A Phase 3 interventional study of Omalizumab and Placebo for Omalizumab in Peanut Allergy and Multi-food Allergy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 10 sites in United States. Open to participants aged 1 Year to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 3, Interventional, and Treatment
This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 1 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may be allergic to more than two other foods, the primary endpoint/outcome in this study will only be assessed in peanut and two other foods for each participant. The primary objective of the study is to compare the ability to consume foods without dose-limiting symptoms during a double-blind placebo-controlled food challenge (DBPCFC), after treatment with either omalizumab or placebo for omalizumab.
Food allergy affects about 15 million people in the United States. This includes 6 million children. The current treatment for food allergy is to avoid eating the foods that may cause an allergic reaction and have medications such as epinephrine (adrenaline) in case of a reaction. However, accidental exposures can be extremely difficult to avoid, particularly if you are allergic to multiple foods. The risks of accidental exposures and life-threatening reactions can place a large burden on patients and their families.
Investigators in this study would like to learn if omalizumab injections alone or in combination with multi-allergen oral immunotherapy (OIT) will help people with multiple food allergies eat foods to which they are allergic. Oral means that you will take the food allergen (peanut and 2 other foods to which you are allergic) by mouth. If you are allergic to more than 3 foods, this study will only provide OIT for peanut and 2 other foods.
There are 3 stages to the study:
In Stage 1, investigators would like to learn:
Stage 1 will also have an extra part so that 60 participants will receive omalizumab and everyone (the investigators conducting the research and study participants) will know it. This is why it is called the open label extension. This part of the study will assist investigators in learning if receiving omalizumab for a longer time may work better at decreasing allergic reactions.
In Stage 2, investigators would like to learn:
In Stage 3, investigators would like to learn:
In all stages, investigators would like to learn:
Participation will last up to 56 months (4 years and 8 months).
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's enrollment of 458 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Individuals who meet all of the following criteria are eligible for enrollment as study participants:
Peanut allergic: participant must meet all of the following criteria to minimize the chance that the participant will develop natural tolerance to peanut over the course of the study:
Allergic to at least two of the six other foods (milk, egg, wheat, cashew, hazelnut, walnut): each participant must meet all of the following criteria for at least two of the six other foods to minimize the chance that the participant will develop natural tolerance to at least two of the six other foods over the course of the study:
For women of childbearing potential, must agree to,during the treatment period and for 60 days after the last dose of study drug:
Exclusion Criteria:
Individuals who meet any of the following criteria are not eligible for enrollment as study participants:
Sensitivity or suspected/known allergy to any ingredients (including ) of the
drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin).
Poorly controlled or severe asthma/wheezing at Screening, defined by at least one of the following criteria:
Past or current medical problems (e.g., severe latex allergy), history of other chronic diseases (other than asthma/wheezing, AD, or rhinitis) requiring therapy (e.g., heart disease, diabetes), findings from physical assessment, or abnormalities in clinical laboratory testing that are not listed above, which, in the opinion of the PI, may:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible participants are randomized to receive omalizumab by subcutaneous injection either every 2 weeks or every 4 weeks for 16 to 20 weeks. The dose administered and the dosing interval are determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table. After 16 weeks of treatment, each participant will complete double-blind placebo-controlled food challenge (DBPCFCs) to each of their three specific foods to a cumulative dose of 6044 mg protein of each food. Throughout Stage 1, each participant will be instructed to strictly avoid all foods to which they are allergic. The first 60 participants who complete all four DBPCFCs at the end of Stage 1 will participate in the Stage 1 Open Label Extension (OLE).All other participants who complete all four DBPCFCs will move Stage 2 of the study.
Drug: Omalizumab
OLE: Open Label Extension, Long-Term Treatment with Omalizumab. Participants will receive 24 weeks of open label omalizumab in accordance with the omalizumab dosing table defined in the study protocol. Omalizumab is administered by subcutaneous injection either every 2 weeks or every 4 weeks for 24 weeks. The dose administered and the dosing interval are determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table. After 24 weeks of treatment, each participant will complete DBPCFCs to each of their three specific foods to a cumulative dose of 8044 mg protein of each food. Each participant who completes all four DBPCFCs at the end of the Stage 1 OLE will move on to Stage 3 of the study. Throughout Stage 1 OLE, each participant will be instructed to strictly avoid all foods to which they are allergic.
Drug: Omalizumab
Eligible participants are randomized to receive placebo for omalizumab by subcutaneous injection either every 2 weeks or every 4 weeks for 16 to 20 weeks. The dose administered and the dosing interval are determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table. After 16 weeks of treatment, each participant will complete DBPCFCs to each of their three specific foods to a cumulative dose of 6044 mg protein of each food. Throughout Stage 1, each participant will be instructed to strictly avoid all foods to which they are allergic. The first 60 participants who complete all four DBPCFCs at the end of Stage 1 will participate in the Stage 1 OLE. All other participants who complete all four DBPCFCs will move Stage 2 of the study.
Drug: Placebo for Omalizumab
Participants will receive eight weeks of treatment with open label omalizumab in accordance with the omalizumab dosing table specified in the study protocol, administered by subcutaneous injection. The dose administered and the dosing interval are determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table. After completion of eight weeks of open label omalizumab, participants will be randomized 1:1 to either: * Omalizumab-facilitated oral immunotherapy (OIT): Open label omalizumab + Multi-allergen OIT for eight weeks, followed by placebo for omalizumab + Multi-allergen OIT for 44 weeks OR * Omalizumab + placebo OIT: Open label omalizumab + placebo for Multi-allergen OIT for eight weeks, followed by omalizumab + placebo for Multi-allergen OIT for 44 weeks. Throughout Stage 2, each participant will be instructed to strictly avoid all foods to which they are allergic.
Drug: Omalizumab
OIT: oral immunotherapy-Omalizumab as Adjunct Therapy to Multi-Allergen Oral Immunotherapy Participants randomized to open label omalizumab + Multi-allergen OIT for eight weeks, followed by placebo for omalizumab + Multi-allergen OIT for 44 weeks. Throughout Stage 2, each participant will be instructed to strictly avoid all foods to which they are allergic.
Drug: Omalizumab · Drug: Multi-Allergen Oral Immunotherapy
OIT: oral immunotherapy Participants randomized to open label omalizumab + placebo for Multi-allergen OIT for eight weeks, followed by omalizumab + placebo for Multi-allergen OIT for 44 weeks. Throughout Stage 2, each participant will be instructed to strictly avoid all foods to which they are allergic.
Drug: Omalizumab · Drug: Placebo for Multi-Allergen Oral Immunotherapy
DBPCFC Based Treatment-Long-term Follow-up Treatment Plan for Peanut and Each of the Two Other Participant-Specific Foods. Upon completion of the DBPCFCs at the end of Stage 1 OLE or Stage 2, each participant will receive a separate treatment plan for peanut and each of the two other participant-specific foods based on the results of the DBPCFCs. A treatment plan will include instructions for one of the following: * Long-term follow-up with dietary consumption of a food; * Long-term follow-up with avoidance of a food; or * Rescue OIT for a food. The treatment plan for each food may change throughout Stage 3 depending on a participant's response to treatment. Once a participant enters Stage 3, the participant will have a minimum of 12 months follow-up until at least December 2022. Note: Participants will be instructed to strictly avoid a food if they receive rescue OIT for the food during Stage 3.
Other: Double-Blind Placebo-Controlled Food Challenge Based Treatment
Omalizumab will be supplied in pre-filled syringes (PFS). PFS of omalizumab will be provided to the clinical research units as 75 mg and 150 mg dosage forms.
Also known as: Xolair®
Placebo contains the same ingredients as the omalizumab formulation, excluding omalizumab. Placebo will be supplied in pre-filled syringes (PFS). PFS of placebo will be provided to the clinical research units as 75 mg and 150 mg dosage forms.
Also known as: Placebo
Multi-allergen OIT will be any of the following drug products: peanut, milk, egg, wheat, cashew, hazelnut, and walnut (all food protein flours). A prescription for each participant for the appropriate dose of each of the allergens will be prepared. The pharmacist will compound the appropriate allergens and dispense the Multi-allergen OIT dose in a blinded (masked) fashion. The Clinical Research Unit (CRU) staff will administer food flour to the participant orally in an age-appropriate food vehicle (e.g., applesauce, pudding, etc.). Dosage will be administered according to the study protocol.
Also known as: Multi-Allergen OIT
Oat flour will be used for placebo for Multi-allergen OIT. Route: by mouth/oral. Dosage will be administered according to the study protocol.
Also known as: Placebo for Multi-Allergen OIT
Each participant will receive a separate treatment plan for peanut and each of the two other participant-specific foods. A treatment plan will include instructions for one of the following: * Long-term follow-up with dietary consumption of a food; or * Long-term follow-up with avoidance of a food; or * Rescue OIT for a food. The treatment plan for each food may change depending on a participant's response to prescribed treatment over time.
Also known as: DBPCFC Based Treatment
Number of Participants by Stage 1 Treatment Assignment, Omalizumab Versus Placebo, Who Successfully Consume a Single Dose of ≥600 mg of Peanut Protein Without Dose-Limiting Symptoms During the DBPCFC Conducted at the End of Treatment Stage 1
Number of participants who successfully consume a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants by Stage 1 Treatment Assignment, Omalizumab Versus Placebo, Who Successfully Consume a Single Dose of ≥1000 mg of Cashew Protein Without Dose-limiting Symptoms During the DBPCFC Conducted at the End of Stage 1
Number of participants who successfully consume a single dose of ≥1000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants by Stage 1 Treatment Assignment, Omalizumab Versus Placebo, Who Successfully Consume a Single Dose of ≥1000 mg of Milk Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 1
Number of participants who successfully consume a single dose of ≥1000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants by Stage 1 Treatment Assignment, Omalizumab Versus Placebo, Who Successfully Consume a Single Dose of ≥1000 mg of Egg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 1
Number of participants who successfully consume a single dose of ≥1000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Milk Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Proportion of participants who successfully consume a single dose of ≥600 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Egg Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Proportion of participants who successfully consume a single dose of ≥600 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Wheat Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Proportion of participants who successfully consume a single dose of ≥600 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Cashew Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Proportion of participants who successfully consume a single dose of ≥600 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Hazelnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Proportion of participants who successfully consume a single dose of ≥600 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Walnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Proportion of participants who successfully consume a single dose of ≥600 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Food Protein Without Dose-limiting Symptoms for at Least Two Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC), at the End of Stage 1
Proportion of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Food Protein Without Dose-limiting Symptoms for All Three Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC), at the End of Stage
Proportion of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Peanut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1.
Proportion of participants who successfully consume a single dose of ≥1000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Wheat Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1.
Proportion of participants who successfully consume a single dose of ≥1000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Hazelnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1.
Proportion of participants who successfully consume a single dose of ≥1000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Walnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1.
Proportion of participants who successfully consume a single dose of ≥1000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Food Protein Without Dose-limiting Symptoms for at Least Two Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Proportion of participants who successfully consume a single dose of ≥1000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥1000mg of Food Protein Without Dose-limiting Symptoms for All Three Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Proportion of participants who successfully consume a single dose of ≥1000mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Peanut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Number of participants who successfully consume ≥1 dose of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Milk Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Number of participants who successfully consume ≥1 dose of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Egg Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Number of participants who successfully consume ≥1 dose of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Wheat Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Number of participants who successfully consume ≥1 dose of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Cashew Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Number of participants who successfully consume ≥1 dose of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Hazelnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Number of participants who successfully consume ≥1 dose of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Walnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Number of participants who successfully consume ≥1 dose of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Food Protein Without Dose-limiting Symptoms for at Least Two Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1.
Number of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Food Protein Without Dose-limiting Symptoms for All Three Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1.
Number of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Peanut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1.
Number of participants who successfully consume 2 doses of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Milk Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Number of participants who successfully consume 2 doses of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Egg Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Number of participants who successfully consume 2 doses of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Wheat Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Number of participants who successfully consume 2 doses of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Cashew Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Number of participants who successfully consume 2 doses of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Hazelnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Number of participants who successfully consume 2 doses of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Walnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Number of participants who successfully consume 2 doses of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Food Protein Without Dose-limiting Symptoms for at Least Two Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Number of participants who successfully consume 2 doses of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Food Protein Without Dose-limiting Symptoms for All Three Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1
Number of participants who successfully consume 2 doses of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Foods Consumed at a Single Dose of ≥600 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 1.
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 600 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Foods Consumed at a Single Dose of ≥1000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 1.
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥1000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Foods Consumed at ≥1 Dose of 2000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 1
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 1 dose of 2000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Foods Consumed at 2 Doses of 2000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 1
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of 2 doses of 2000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Peanut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Milk Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥600 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Egg Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥600 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Wheat Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥600 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Cashew Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥600 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Hazelnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥600 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Walnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥600 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Food Protein Without Dose-limiting Symptoms for at Least Two Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Food Protein Without Dose-limiting Symptoms for All Three Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Peanut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥1000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Milk Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥1000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Egg Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥1000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Wheat Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥1000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Cashew Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥1000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Hazelnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥1000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Walnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥1000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Food Protein Without Dose-limiting Symptoms for at Least Two Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥1000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Food Protein Without Dose-limiting Symptoms for All Three Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume a single dose of ≥1000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Peanut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥1 dose of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Milk Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥1 dose of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Egg Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥1 dose of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Wheat Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥1 dose of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Cashew Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥1 dose of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Hazelnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥1 dose of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Walnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥1 dose of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Food Protein Without Dose-limiting Symptoms for at Least Two Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: Time Frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Food Protein Without Dose-limiting Symptoms for All Three Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥2 Doses of 2000 mg of Peanut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥2 doses of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥2 Doses of 2000 mg of Milk Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥2 doses of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥2 Doses of 2000 mg of Egg Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥2 doses of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥2 Doses of 2000 mg of Wheat Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥2 doses of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥2 Doses of 2000 mg of Cashew Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥2 doses of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥2 Doses of 2000 mg of Hazelnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥2 doses of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥2 Doses of 2000 mg of Walnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥2 doses of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥2 Doses of 2000 mg of Food Protein Without Dose-limiting Symptoms for at Least Two Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥2 doses of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume ≥2 Doses of 2000 mg of Food Protein Without Dose-limiting Symptoms for All Three Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume ≥2 doses of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume 3 Doses of 2000 mg of Peanut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume 3 doses of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume 3 Doses of 2000 mg of Milk Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume 3 doses of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume 3 Doses of 2000 mg of Egg Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume 3 doses of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume 3 Doses of 2000 mg of Wheat Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume 3 doses of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume 3 Doses of 2000 mg of Cashew Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume 3 doses of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume 3 Doses of 2000 mg of Hazelnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume 3 doses of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume 3 Doses of 2000 mg of Walnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume 3 doses of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume 3 Doses of 2000 mg of Food Protein Without Dose-limiting Symptoms for at Least Two Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume 3 doses of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Who Successfully Consume 3 Doses of 2000 mg of Food Protein Without Dose-limiting Symptoms for All Three Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
Number of participants who successfully consume 3 doses of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Foods Consumed at a Single Dose of ≥600 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 2.
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 600 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Foods Consumed at a Single Dose of ≥1000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 2.
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 1000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Foods Consumed at ≥1 Dose of 2000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 2.
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 1 dose of 2000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Foods Consumed at ≥2 Doses of 2000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 2.
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 2 doses of 2000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Foods Consumed at 3 Doses of 2000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 2.
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 3 doses of 2000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
Time frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
Number of Participants Demonstrating Success on the Dietary Consumption Treatment Plan for Peanut at 3 and 6 Months Following the Start of Stage 3.
Success is defined as a median daily peanut intake of ≥300mg on the dietary consumption treatment plan where participants were assigned to follow guided dietary instructions. The median consumption amount is derived from available daily diaries between day 77 and 105 for the Month 3 timepoint and days 153 and 213 for the Month 6 timepoint. The outcome was considered a failure if the participant discontinued prior to the window, diary data were not provided, the median amount was \<300mg, or the participant transitioned off the dietary consumption treatment plan to avoidance or rescue OIT.
Time frame: Month 3 and Month 6 following the start of Stage 3
Number of Participants Demonstrating Success on the Dietary Consumption Treatment Plan for Cashew at 3 and 6 Months Following the Start of Stage 3.
Among participants with cashew as an assigned food, success is defined as a median daily cashew intake of ≥300 mg on the dietary consumption treatment plan where participants were assigned to follow guided dietary instructions. The median dietary consumption amount is derived from available daily diaries between day 77 and 105 for the Month 3 timepoint and days 153 and 213 for the Month 6 timepoint. The outcome was considered a failure if the participant discontinued prior to the window, diary data were not provided, the median amount was \<300mg, or the participant transitioned off the dietary consumption treatment plan to avoidance or rescue OIT.
Time frame: Month 3 and Month 6 following the start of Stage 3
Number of Participants Demonstrating Success on the Dietary Consumption Treatment Plan for Milk at 3 and 6 Months Following the Start of Stage 3.
Among participants with milk as an assigned food, success is defined as a median daily milk intake of ≥300 mg on the dietary consumption treatment plan where participants were assigned to follow guided dietary instructions. The median dietary consumption amount is derived from available daily diaries between day 77 and 105 for the Month 3 timepoint and days 153 and 213 for the Month 6 timepoint. The outcome was considered a failure if the participant discontinued prior to the window, diary data were not provided, the median amount was \<300mg, or the participant transitioned off the dietary consumption treatment plan to avoidance or rescue OIT.
Time frame: Month 3 and Month 6 following the start of Stage 3
Number of Participants Demonstrating Success on the Dietary Consumption Treatment Plan for Egg at 3 and 6 Months Following the Start of Stage 3.
Among participants with egg as an assigned food, success is defined as a median daily egg intake of ≥300 mg on the dietary consumption treatment plan where participants were assigned to follow guided dietary instructions. The median dietary consumption amount is derived from available daily diaries between day 77 and 105 for the Month 3 timepoint and days 153 and 213 for the Month 6 timepoint. The outcome was considered a failure if the participant discontinued prior to the window, diary data were not provided, the median amount was \<300mg, or the participant transitioned off the dietary consumption treatment plan to avoidance or rescue OIT.
Time frame: Month 3 and Month 6 following the start of Stage 3
Number of Participants Demonstrating Success on the Dietary Consumption Treatment Plan for Walnut at 3 and 6 Months Following the Start of Stage 3.
Among participants with walnut as an assigned food, success is defined as a median daily walnut intake of ≥300 mg on the dietary consumption treatment plan where participants were assigned to follow guided dietary instructions. The median dietary consumption amount is derived from available daily diaries between day 77 and 105 for the Month 3 timepoint and days 153 and 213 for the Month 6 timepoint. The outcome was considered a failure if the participant discontinued prior to the window, diary data were not provided, the median amount was \<300mg, or the participant transitioned off the dietary consumption treatment plan to avoidance or rescue OIT.
Time frame: Month 3 and Month 6 following the start of Stage 3
Number of Participants Demonstrating Success on the Dietary Consumption Treatment Plan for Hazelnut at 3 and 6 Months Following the Start of Stage 3.
Among participants with hazelnut as an assigned food, success is defined as a median daily hazelnut intake of ≥300 mg on the dietary consumption treatment plan where participants were assigned to follow guided dietary instructions. The median dietary consumption amount is derived from available daily diaries between day 77 and 105 for the Month 3 timepoint and days 153 and 213 for the Month 6 timepoint. The outcome was considered a failure if the participant discontinued prior to the window, diary data were not provided, the median amount was \<300mg, or the participant transitioned off the dietary consumption treatment plan to avoidance or rescue OIT.
Time frame: Month 3 and Month 6 following the start of Stage 3
Number of Participants Demonstrating Success on the Dietary Consumption Treatment Plan for Wheat at 3 and 6 Months Following the Start of Stage 3.
Among participants with wheat as an assigned food, success is defined as a median daily wheat intake of ≥300 mg on the dietary consumption treatment plan where participants were assigned to follow guided dietary instructions. The median dietary consumption amount is derived from available daily diaries between day 77 and 105 for the Month 3 timepoint and days 153 and 213 for the Month 6 timepoint. The outcome was considered a failure if the participant discontinued prior to the window, diary data were not provided, the median amount was \<300mg, or the participant transitioned off the dietary consumption treatment plan to avoidance or rescue OIT.
Time frame: Month 3 and Month 6 following the start of Stage 3
Enrollment was open from July 2019 through March 2023.
| Milestone | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab | Stage 1 OLE (From Stage 1 Omalizumab) | Stage 1 OLE (From Stage 1 Placebo) | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT | Stage 3 (From OLE) | Stage 3 (From Stage 2 Omalizumab - Facilitated OIT) | Stage 3 (From Stage 2 Omalizumab + Placebo OIT) |
|---|---|---|---|---|---|---|---|---|---|
| Started | 120 | 60 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 115 | 60 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Subject withdrawal by parent or guardian | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab | Stage 1 OLE (From Stage 1 Omalizumab) | Stage 1 OLE (From Stage 1 Placebo) | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT | Stage 3 (From OLE) | Stage 3 (From Stage 2 Omalizumab - Facilitated OIT) | Stage 3 (From Stage 2 Omalizumab + Placebo OIT) |
|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 39 | 21 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 39 | 21 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab | Stage 1 OLE (From Stage 1 Omalizumab) | Stage 1 OLE (From Stage 1 Placebo) | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT | Stage 3 (From OLE) | Stage 3 (From Stage 2 Omalizumab - Facilitated OIT) | Stage 3 (From Stage 2 Omalizumab + Placebo OIT) |
|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 59 | 58 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 30 | 51 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 29 | 7 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 9 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 3 | 4 | 0 | 0 | 0 |
| Withdrew: Subject withdrawal by parent or guardian | 0 | 0 | 0 | 0 | 16 | 2 | 0 | 0 | 0 |
| Withdrew: To use commercially available xolair | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Milestone | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab | Stage 1 OLE (From Stage 1 Omalizumab) | Stage 1 OLE (From Stage 1 Placebo) | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT | Stage 3 (From OLE) | Stage 3 (From Stage 2 Omalizumab - Facilitated OIT) | Stage 3 (From Stage 2 Omalizumab + Placebo OIT) |
|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 60 | 30 | 51 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 55 | 25 | 45 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 5 | 6 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 |
| Withdrew: Subject withdrawal by parent or guardian | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 |
| Withdrew: To use commercially available xolair | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 |
| Milestone | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab | Stage 1 OLE (From Stage 1 Omalizumab) | Stage 1 OLE (From Stage 1 Placebo) | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT | Stage 3 (From OLE) | Stage 3 (From Stage 2 Omalizumab - Facilitated OIT) | Stage 3 (From Stage 2 Omalizumab + Placebo OIT) |
|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 55 | 25 | 45 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 45 | 21 | 35 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 4 | 10 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Pregnancy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 2 | 0 |
| Withdrew: Subject withdrawal by parent or guardian | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 1 | 5 |
| Withdrew: To use commercially available xolair | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Number of participants who successfully consume a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Omalizumab | Placebo for Omalizumab |
|---|---|---|
| Success | 79 | 4 |
| Failure | 39 | 55 |
Number of participants who successfully consume a single dose of ≥1000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 28 | 1 |
| Failure | 40 | 30 |
Number of participants who successfully consume a single dose of ≥1000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 27 | 2 |
| Failure | 14 | 19 |
Number of participants who successfully consume a single dose of ≥1000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 34 | 0 |
| Failure | 17 | 20 |
Proportion of participants who successfully consume a single dose of ≥600 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 29 | 2 |
| Failure | 12 | 19 |
Proportion of participants who successfully consume a single dose of ≥600 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 37 | 0 |
| Failure | 14 | 20 |
Proportion of participants who successfully consume a single dose of ≥600 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 9 | 1 |
| Failure | 3 | 7 |
Proportion of participants who successfully consume a single dose of ≥600 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 32 | 1 |
| Failure | 36 | 30 |
Proportion of participants who successfully consume a single dose of ≥600 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 13 | 1 |
| Failure | 4 | 6 |
Proportion of participants who successfully consume a single dose of ≥600 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 32 | 4 |
| Failure | 15 | 27 |
Proportion of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 82 | 4 |
| Failure | 36 | 55 |
Proportion of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 55 | 2 |
| Failure | 63 | 57 |
Proportion of participants who successfully consume a single dose of ≥1000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 75 | 2 |
| Failure | 43 | 57 |
Proportion of participants who successfully consume a single dose of ≥1000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 9 | 1 |
| Failure | 3 | 7 |
Proportion of participants who successfully consume a single dose of ≥1000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 11 | 1 |
| Failure | 6 | 6 |
Proportion of participants who successfully consume a single dose of ≥1000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 30 | 4 |
| Failure | 17 | 27 |
Proportion of participants who successfully consume a single dose of ≥1000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 78 | 3 |
| Failure | 40 | 56 |
Proportion of participants who successfully consume a single dose of ≥1000mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 44 | 1 |
| Failure | 74 | 58 |
Number of participants who successfully consume ≥1 dose of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 67 | 1 |
| Failure | 51 | 58 |
Number of participants who successfully consume ≥1 dose of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 25 | 0 |
| Failure | 16 | 21 |
Number of participants who successfully consume ≥1 dose of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 28 | 0 |
| Failure | 23 | 20 |
Number of participants who successfully consume ≥1 dose of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 8 | 1 |
| Failure | 4 | 7 |
Number of participants who successfully consume ≥1 dose of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 21 | 1 |
| Failure | 47 | 30 |
Number of participants who successfully consume ≥1 dose of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 10 | 1 |
| Failure | 7 | 6 |
Number of participants who successfully consume ≥1 dose of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 29 | 3 |
| Failure | 18 | 28 |
Number of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 64 | 3 |
| Failure | 54 | 56 |
Number of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 36 | 0 |
| Failure | 82 | 59 |
Number of participants who successfully consume 2 doses of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 52 | 1 |
| Failure | 66 | 58 |
Number of participants who successfully consume 2 doses of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 24 | 0 |
| Failure | 17 | 21 |
Number of participants who successfully consume 2 doses of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 25 | 0 |
| Failure | 26 | 20 |
Number of participants who successfully consume 2 doses of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 8 | 0 |
| Failure | 4 | 8 |
Number of participants who successfully consume 2 doses of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 16 | 0 |
| Failure | 52 | 31 |
Number of participants who successfully consume 2 doses of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 7 | 1 |
| Failure | 10 | 6 |
Number of participants who successfully consume 2 doses of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 23 | 1 |
| Failure | 24 | 30 |
Number of participants who successfully consume 2 doses of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 49 | 1 |
| Failure | 69 | 58 |
Number of participants who successfully consume 2 doses of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| Success | 28 | 0 |
| Failure | 90 | 59 |
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 600 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| 0 | 24 | 52 |
| 1 | 12 | 3 |
| 2 | 27 | 2 |
| 3 | 55 | 2 |
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥1000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| 0 | 26 | 52 |
| 1 | 14 | 4 |
| 2 | 34 | 2 |
| 3 | 44 | 1 |
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 1 dose of 2000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| 0 | 30 | 55 |
| 1 | 24 | 1 |
| 2 | 28 | 3 |
| 3 | 36 | 0 |
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of 2 doses of 2000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab |
|---|---|---|
| 0 | 40 | 57 |
| 1 | 29 | 1 |
| 2 | 21 | 1 |
| 3 | 28 | 0 |
Number of participants who successfully consume a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 24 | 45 |
| Failure | 35 | 13 |
Number of participants who successfully consume a single dose of ≥600 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 7 | 13 |
| Failure | 10 | 5 |
Number of participants who successfully consume a single dose of ≥600 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 8 | 16 |
| Failure | 15 | 4 |
Number of participants who successfully consume a single dose of ≥600 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 3 | 5 |
| Failure | 1 | 1 |
Number of participants who successfully consume a single dose of ≥600 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 17 | 21 |
| Failure | 24 | 11 |
Number of participants who successfully consume a single dose of ≥600 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 2 | 9 |
| Failure | 4 | 2 |
Number of participants who successfully consume a single dose of ≥600 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 11 | 21 |
| Failure | 16 | 8 |
Number of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 25 | 45 |
| Failure | 34 | 13 |
Number of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 22 | 37 |
| Failure | 37 | 21 |
Number of participants who successfully consume a single dose of ≥1000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 19 | 38 |
| Failure | 40 | 20 |
Number of participants who successfully consume a single dose of ≥1000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 4 | 13 |
| Failure | 13 | 5 |
Number of participants who successfully consume a single dose of ≥1000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 8 | 16 |
| Failure | 15 | 4 |
Number of participants who successfully consume a single dose of ≥1000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 3 | 5 |
| Failure | 1 | 1 |
Number of participants who successfully consume a single dose of ≥1000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 15 | 17 |
| Failure | 26 | 15 |
Number of participants who successfully consume a single dose of ≥1000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 2 | 7 |
| Failure | 4 | 4 |
Number of participants who successfully consume a single dose of ≥1000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 9 | 20 |
| Failure | 18 | 9 |
Number of participants who successfully consume a single dose of ≥1000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 21 | 39 |
| Failure | 38 | 19 |
Number of participants who successfully consume a single dose of ≥1000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 15 | 31 |
| Failure | 44 | 27 |
Number of participants who successfully consume ≥1 dose of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 16 | 34 |
| Failure | 43 | 24 |
Number of participants who successfully consume ≥1 dose of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 4 | 12 |
| Failure | 13 | 6 |
Number of participants who successfully consume ≥1 dose of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 6 | 14 |
| Failure | 17 | 6 |
Number of participants who successfully consume ≥1 dose of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 3 | 5 |
| Failure | 1 | 1 |
Number of participants who successfully consume ≥1 dose of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 14 | 14 |
| Failure | 27 | 18 |
Number of participants who successfully consume ≥1 dose of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 2 | 5 |
| Failure | 4 | 6 |
Number of participants who successfully consume ≥1 dose of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 8 | 16 |
| Failure | 19 | 13 |
Number of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 19 | 35 |
| Failure | 40 | 23 |
Number of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 11 | 21 |
| Failure | 48 | 37 |
Number of participants who successfully consume ≥2 doses of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 14 | 31 |
| Failure | 45 | 27 |
Number of participants who successfully consume ≥2 doses of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 3 | 10 |
| Failure | 14 | 8 |
Number of participants who successfully consume ≥2 doses of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 5 | 13 |
| Failure | 18 | 7 |
Number of participants who successfully consume ≥2 doses of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 1 | 5 |
| Failure | 3 | 1 |
Number of participants who successfully consume ≥2 doses of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 8 | 10 |
| Failure | 33 | 22 |
Number of participants who successfully consume ≥2 doses of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 2 | 5 |
| Failure | 4 | 6 |
Number of participants who successfully consume ≥2 doses of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 7 | 15 |
| Failure | 20 | 14 |
Number of participants who successfully consume ≥2 doses of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 13 | 31 |
| Failure | 46 | 27 |
Number of participants who successfully consume ≥2 doses of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 6 | 16 |
| Failure | 53 | 42 |
Number of participants who successfully consume 3 doses of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 12 | 27 |
| Failure | 47 | 31 |
Number of participants who successfully consume 3 doses of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 3 | 10 |
| Failure | 14 | 8 |
Number of participants who successfully consume 3 doses of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 4 | 12 |
| Failure | 19 | 8 |
Number of participants who successfully consume 3 doses of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 1 | 5 |
| Failure | 3 | 1 |
Number of participants who successfully consume 3 doses of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 7 | 8 |
| Failure | 34 | 24 |
Number of participants who successfully consume 3 doses of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 2 | 5 |
| Failure | 4 | 6 |
Number of participants who successfully consume 3 doses of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 6 | 13 |
| Failure | 21 | 16 |
Number of participants who successfully consume 3 doses of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 12 | 27 |
| Failure | 47 | 31 |
Number of participants who successfully consume 3 doses of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| Success | 6 | 14 |
| Failure | 53 | 44 |
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 600 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| 0 | 34 | 10 |
| 1 | 0 | 3 |
| 2 | 3 | 8 |
| 3 | 22 | 37 |
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 1000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| 0 | 35 | 12 |
| 1 | 3 | 7 |
| 2 | 6 | 8 |
| 3 | 15 | 31 |
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 1 dose of 2000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| 0 | 36 | 14 |
| 1 | 4 | 9 |
| 2 | 8 | 14 |
| 3 | 11 | 21 |
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 2 doses of 2000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| 0 | 38 | 16 |
| 1 | 8 | 11 |
| 2 | 7 | 15 |
| 3 | 6 | 16 |
Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 3 doses of 2000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.
| Participants | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT |
|---|---|---|
| 0 | 42 | 19 |
| 1 | 5 | 12 |
| 2 | 6 | 13 |
| 3 | 6 | 14 |
Success is defined as a median daily peanut intake of ≥300mg on the dietary consumption treatment plan where participants were assigned to follow guided dietary instructions. The median consumption amount is derived from available daily diaries between day 77 and 105 for the Month 3 timepoint and days 153 and 213 for the Month 6 timepoint. The outcome was considered a failure if the participant discontinued prior to the window, diary data were not provided, the median amount was \<300mg, or the participant transitioned off the dietary consumption treatment plan to avoidance or rescue OIT.
| Participants | Stage 3 (From Stage 2 Omalizumab - Facilitated OIT) | Stage 3 (From Stage 2 Omalizumab + Placebo OIT) |
|---|---|---|
| Month 3 | 20 | 32 |
| Month 6 | 17 | 29 |
Among participants with cashew as an assigned food, success is defined as a median daily cashew intake of ≥300 mg on the dietary consumption treatment plan where participants were assigned to follow guided dietary instructions. The median dietary consumption amount is derived from available daily diaries between day 77 and 105 for the Month 3 timepoint and days 153 and 213 for the Month 6 timepoint. The outcome was considered a failure if the participant discontinued prior to the window, diary data were not provided, the median amount was \<300mg, or the participant transitioned off the dietary consumption treatment plan to avoidance or rescue OIT.
| Participants | Stage 3 (From Stage 2 Omalizumab - Facilitated OIT) | Stage 3 (From Stage 2 Omalizumab + Placebo OIT) |
|---|---|---|
| Month 3 | 16 | 13 |
| Month 6 | 13 | 14 |
Among participants with milk as an assigned food, success is defined as a median daily milk intake of ≥300 mg on the dietary consumption treatment plan where participants were assigned to follow guided dietary instructions. The median dietary consumption amount is derived from available daily diaries between day 77 and 105 for the Month 3 timepoint and days 153 and 213 for the Month 6 timepoint. The outcome was considered a failure if the participant discontinued prior to the window, diary data were not provided, the median amount was \<300mg, or the participant transitioned off the dietary consumption treatment plan to avoidance or rescue OIT.
| Participants | Stage 3 (From Stage 2 Omalizumab - Facilitated OIT) | Stage 3 (From Stage 2 Omalizumab + Placebo OIT) |
|---|---|---|
| Month 3 | 6 | 11 |
| Month 6 | 4 | 10 |
Among participants with egg as an assigned food, success is defined as a median daily egg intake of ≥300 mg on the dietary consumption treatment plan where participants were assigned to follow guided dietary instructions. The median dietary consumption amount is derived from available daily diaries between day 77 and 105 for the Month 3 timepoint and days 153 and 213 for the Month 6 timepoint. The outcome was considered a failure if the participant discontinued prior to the window, diary data were not provided, the median amount was \<300mg, or the participant transitioned off the dietary consumption treatment plan to avoidance or rescue OIT.
| Participants | Stage 3 (From Stage 2 Omalizumab - Facilitated OIT) | Stage 3 (From Stage 2 Omalizumab + Placebo OIT) |
|---|---|---|
| Month 3 | 8 | 12 |
| Month 6 | 8 | 11 |
Among participants with walnut as an assigned food, success is defined as a median daily walnut intake of ≥300 mg on the dietary consumption treatment plan where participants were assigned to follow guided dietary instructions. The median dietary consumption amount is derived from available daily diaries between day 77 and 105 for the Month 3 timepoint and days 153 and 213 for the Month 6 timepoint. The outcome was considered a failure if the participant discontinued prior to the window, diary data were not provided, the median amount was \<300mg, or the participant transitioned off the dietary consumption treatment plan to avoidance or rescue OIT.
| Participants | Stage 3 (From Stage 2 Omalizumab - Facilitated OIT) | Stage 3 (From Stage 2 Omalizumab + Placebo OIT) |
|---|---|---|
| Month 3 | 10 | 16 |
| Month 6 | 9 | 15 |
Among participants with hazelnut as an assigned food, success is defined as a median daily hazelnut intake of ≥300 mg on the dietary consumption treatment plan where participants were assigned to follow guided dietary instructions. The median dietary consumption amount is derived from available daily diaries between day 77 and 105 for the Month 3 timepoint and days 153 and 213 for the Month 6 timepoint. The outcome was considered a failure if the participant discontinued prior to the window, diary data were not provided, the median amount was \<300mg, or the participant transitioned off the dietary consumption treatment plan to avoidance or rescue OIT.
| Participants | Stage 3 (From Stage 2 Omalizumab - Facilitated OIT) | Stage 3 (From Stage 2 Omalizumab + Placebo OIT) |
|---|---|---|
| Month 3 | 2 | 4 |
| Month 6 | 2 | 4 |
Among participants with wheat as an assigned food, success is defined as a median daily wheat intake of ≥300 mg on the dietary consumption treatment plan where participants were assigned to follow guided dietary instructions. The median dietary consumption amount is derived from available daily diaries between day 77 and 105 for the Month 3 timepoint and days 153 and 213 for the Month 6 timepoint. The outcome was considered a failure if the participant discontinued prior to the window, diary data were not provided, the median amount was \<300mg, or the participant transitioned off the dietary consumption treatment plan to avoidance or rescue OIT.
| Participants | Stage 3 (From Stage 2 Omalizumab - Facilitated OIT) | Stage 3 (From Stage 2 Omalizumab + Placebo OIT) |
|---|---|---|
| Month 3 | 2 | 4 |
| Month 6 | 1 | 4 |
Collected over AEs were collected during study participation and followed until resolution, end of participation, or ≥30 days after discontinuation. AE were mapped to stage by onset date: Stage 1 (S1) ~16-20 weeks: 1st S1 injection-discontinuation or up to start of the succeeding stage Stage 1 OLE (S1OLE) ~24 weeks: 1st S1OLE injection-S3 start Stage 2 (S2) ~54 weeks: 1st S2 injection-S2 discontinuation or up to S3 start Stage 3 (S3) ~12 months: 1st S3 visit-S3 discontinuation or study completion. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stage 1 Omalizumab | 0/120 (0%) | 4/120 (3.3%) | 77/120 (64.2%) |
| Stage 1 Placebo for Omalizumab | 0/60 (0%) | 1/60 (1.7%) | 47/60 (78.3%) |
| Stage 1 OLE (From Stage 1 Omalizumab) | 0/39 (0%) | 0/39 (0%) | 26/39 (66.7%) |
| Stage 1 OLE (From Stage 1 Placebo for Omalizumab) | 0/21 (0%) | 0/21 (0%) | 19/21 (90.5%) |
| Stage 2 Omalizumab-Facilitated OIT | 0/59 (0%) | 18/59 (30.5%) | 57/59 (96.6%) |
| Stage 2 Omalizumab + Placebo OIT | 0/58 (0%) | 0/58 (0%) | 57/58 (98.3%) |
| Stage 3 (From OLE) | 0/60 (0%) | 8/60 (13.3%) | 58/60 (96.7%) |
| Stage 3 (From Stage 2 Omalizumab - Facilitated OIT) | 0/30 (0%) | 3/30 (10%) | 26/30 (86.7%) |
| Stage 3 (From Stage 2 Omalizumab + Placebo OIT) | 0/51 (0%) | 5/51 (9.8%) | 49/51 (96.1%) |
| Event | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab | Stage 1 OLE (From Stage 1 Omalizumab) | Stage 1 OLE (From Stage 1 Placebo for Omalizumab) | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT | Stage 3 (From OLE) | Stage 3 (From Stage 2 Omalizumab - Facilitated OIT) | Stage 3 (From Stage 2 Omalizumab + Placebo OIT) |
|---|---|---|---|---|---|---|---|---|---|
| HypersensitivityImmune system disorders | 0/120 | 1/60 | 0/39 | 0/21 | 18/59 | 0/58 | 8/60 | 2/30 | 4/51 |
| Enterovirus infectionInfections and infestations | 0/120 | 0/60 | 0/39 | 0/21 | 0/59 | 0/58 | 0/60 | 1/30 | 0/51 |
| Rhinovirus infectionInfections and infestations | 0/120 | 0/60 | 0/39 | 0/21 | 0/59 | 0/58 | 0/60 | 1/30 | 0/51 |
| Status asthmaticusRespiratory, thoracic and mediastinal disorders | 0/120 | 0/60 | 0/39 | 0/21 | 0/59 | 0/58 | 0/60 | 1/30 | 0/51 |
| Subchorionic haemorrhagePregnancy, puerperium and perinatal conditions | 0/120 | 0/60 | 0/39 | 0/21 | 0/59 | 0/58 | 0/60 | 0/30 | 1/51 |
| NauseaGastrointestinal disorders | 0/120 | 0/60 | 0/39 | 0/21 | 1/59 | 0/58 | 0/60 | 0/30 | 0/51 |
| PallorVascular disorders | 0/120 | 0/60 | 0/39 | 0/21 | 1/59 | 0/58 | 0/60 | 0/30 | 0/51 |
| Systemic inflammatory response syndromeGeneral disorders and administration site conditions | 1/120 | 0/60 | 0/39 | 0/21 | 0/59 | 0/58 | 0/60 | 0/30 | 0/51 |
| Infectious mononucleosisInfections and infestations | 1/120 | 0/60 | 0/39 | 0/21 | 0/59 | 0/58 | 0/60 | 0/30 | 0/51 |
| Liver function test increasedInvestigations | 1/120 | 0/60 | 0/39 | 0/21 | 0/59 | 0/58 | 0/60 | 0/30 | 0/51 |
| Event | Stage 1 Omalizumab | Stage 1 Placebo for Omalizumab | Stage 1 OLE (From Stage 1 Omalizumab) | Stage 1 OLE (From Stage 1 Placebo for Omalizumab) | Stage 2 Omalizumab-Facilitated OIT | Stage 2 Omalizumab + Placebo OIT | Stage 3 (From OLE) | Stage 3 (From Stage 2 Omalizumab - Facilitated OIT) | Stage 3 (From Stage 2 Omalizumab + Placebo OIT) |
|---|---|---|---|---|---|---|---|---|---|
| HypersensitivityImmune system disorders | 26/120 | 25/60 | 8/39 | 4/21 | 44/59 | 20/58 | 38/60 | 14/30 | 32/51 |
| Upper respiratory tract infectionInfections and infestations | 5/120 | 3/60 | 0/39 | 4/21 | 24/59 | 24/58 | 19/60 | 9/30 | 11/51 |
| Corona virus infectionInfections and infestations | 9/120 | 4/60 | 1/39 | 0/21 | 15/59 | 22/58 | 18/60 | 3/30 | 4/51 |
| VomitingGastrointestinal disorders | 5/120 | 1/60 | 2/39 | 1/21 | 21/59 | 7/58 | 5/60 | 3/30 | 8/51 |
| Viral infectionInfections and infestations | 6/120 | 3/60 | 1/39 | 1/21 | 11/59 | 8/58 | 11/60 | 1/30 | 6/51 |
| PyrexiaGeneral disorders and administration site conditions | 6/120 | 2/60 | 1/39 | 0/21 | 9/59 | 10/58 | 3/60 | 4/30 | 8/51 |
| Abdominal painGastrointestinal disorders | 4/120 | 2/60 | 0/39 | 1/21 | 10/59 | 5/58 | 3/60 | 3/30 | 5/51 |
| CoughRespiratory, thoracic and mediastinal disorders | 5/120 | 3/60 | 1/39 | 0/21 | 8/59 | 9/58 | 3/60 | 1/30 | 5/51 |
| Injection site reactionGeneral disorders and administration site conditions | 12/120 | 5/60 | 5/39 | 3/21 | 3/59 | 8/58 | 2/60 | 0/30 | 0/51 |
| Gastroenteritis viralInfections and infestations | 2/120 | 0/60 | 0/39 | 0/21 | 5/59 | 8/58 | 6/60 | 3/30 | 2/51 |
Full Analysis Set - Stage 1 (FA-S1): All participants who have been randomized to receive either omalizumab or placebo for omalizumab in Stage 1. Participants will be analyzed according to the treatment arm to which they were randomized in Stage 1, regardless of the treatment actually received in Stage 1.
| Age, Continuous(years) | Omalizumab | Placebo for Omalizumab | Total |
|---|---|---|---|
| Mean | 7.8 ± 4.87 | 8.0 ± 5.19 | 7.8 ± 5.0 |
| Age, Customized(Participants) | Omalizumab | Placebo for Omalizumab | Total |
|---|---|---|---|
| < 18 years | 118 | 59 | 177 |
| 18-64 years | 2 | 1 | 3 |
| ≥ 65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Omalizumab | Placebo for Omalizumab | Total |
|---|---|---|---|
| Female | 49 | 28 | 77 |
| Male | 71 | 32 | 103 |
| Ethnicity (NIH/OMB)(Participants) | Omalizumab | Placebo for Omalizumab | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 4 | 14 |
| Not Hispanic or Latino | 110 | 56 | 166 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Omalizumab | Placebo for Omalizumab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 12 | 12 | 24 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 4 | 14 |
| White | 74 | 37 | 111 |
| More than one race | 23 | 7 | 30 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Omalizumab | Placebo for Omalizumab | Total |
|---|---|---|---|
| United States | 120 | 60 | 180 |
| Body Mass Index(kg/m²) | Omalizumab | Placebo for Omalizumab | Total |
|---|---|---|---|
| Mean | 17.457 ± 3.0438 | 17.215 ± 3.6763 | 17.377 ± 3.2599 |
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Studies of the drug tested here: Omalizumab
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