A Phase 2 interventional study of omalizumab in Peanut Hypersensitivity, sponsored by Genentech, Inc.. Completed. Open to participants aged 6 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Phase 2, Interventional, and Treatment
This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who provide consent to participate in this study.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's enrollment of 11 is below the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →Genentech, Inc. is the lead sponsor of 517 studies on the registry; 20 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 52 (55%) have results posted.
First submitted after Genentech, Inc. became part of Hoffmann-La Roche.
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.
Exclusion Criteria:
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.
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.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
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.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: omalizumab
Subcutaneous repeating dose
Serious Adverse Events
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator
Time frame: Through Week 52
Food Allergen Exposure, Assessed on Patient-reported Questionnaire
Participants were asked to record every 4 weeks in the food-related allergic event questionnaire: "Whether you were exposed to peanut, tree nut (cashew, almond, etc.), shellfish (shrimp, crab, etc.), eggs, milk, or other (please specify)" and "Did you have a reaction? (Yes/No)."
Time frame: Every 4 weeks through Week 52
Food-allergic Reactions As Assessed by the Ewan Scale
The Ewan scale has five ascending grades of severity from "Grade 1" to "Grade 5" (as well, there is a possible value of "Not Applicable"). Grade 1 criteria: localized cutaneous erythema/urticaria/angioedema/oral pruritus. Grade 2 criteria: generalized erythema/urticaria/angioedema. Grade 3 criteria: Grade 1 or 2 events plus GI symptoms/rhinoconjunctivitis. Grade 4 criteria: mild laryngeal edema (voice change, tight throat) and/or mild asthma. Grade 5 criteria: pronounced dyspnea and/or hypotensive symptoms (light headedness/collapse/loss of consciousness). Following a report of an allergic reaction to food on a patient-reported questionnaire, the reaction is graded by the study coordinator or Principle Investigator.
Time frame: Through Week 52
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All AEs that do not meet any of the criteria for serious should be regarded as nonserious AEs.
Time frame: Through Week 52
| Milestone | Omalizumab (Placebo in Q2788g) | Omalizumab (Omalizumab in Q2788g) |
|---|---|---|
| Started | 4 | 7 |
| Completed | 3 | 7 |
| Not completed | 1 | 0 |
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator
| participants | Omalizumab (Placebo in Q2788g) | Omalizumab (Omalizumab in Q2788g) |
|---|---|---|
| Overdose | 0 | 1 |
| Depression | 0 | 1 |
Participants were asked to record every 4 weeks in the food-related allergic event questionnaire: "Whether you were exposed to peanut, tree nut (cashew, almond, etc.), shellfish (shrimp, crab, etc.), eggs, milk, or other (please specify)" and "Did you have a reaction? (Yes/No)."
| participants | Omalizumab (Placebo in Q2788g) | Omalizumab (Omalizumab in Q2788g) |
|---|---|---|
| Food Allergen Exposure, Assessed on Patient-reported Questionnaire | 1 | 3 |
The Ewan scale has five ascending grades of severity from "Grade 1" to "Grade 5" (as well, there is a possible value of "Not Applicable"). Grade 1 criteria: localized cutaneous erythema/urticaria/angioedema/oral pruritus. Grade 2 criteria: generalized erythema/urticaria/angioedema. Grade 3 criteria: Grade 1 or 2 events plus GI symptoms/rhinoconjunctivitis. Grade 4 criteria: mild laryngeal edema (voice change, tight throat) and/or mild asthma. Grade 5 criteria: pronounced dyspnea and/or hypotensive symptoms (light headedness/collapse/loss of consciousness). Following a report of an allergic reaction to food on a patient-reported questionnaire, the reaction is graded by the study coordinator or Principle Investigator.
| participants | Omalizumab (Placebo in Q2788g) | Omalizumab (Omalizumab in Q2788g) |
|---|---|---|
| Grade 1 | 0 | 1 |
| Grade 2 | 0 | 0 |
| Grade 3 | 1 | 2 |
| Grade 4 | 0 | 0 |
| Grade 5 | 0 | 0 |
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All AEs that do not meet any of the criteria for serious should be regarded as nonserious AEs.
| participants | Omalizumab (Placebo in Q2788g) | Omalizumab (Omalizumab in Q2788g) |
|---|---|---|
| Lymphadenopathy | 0 | 1 |
| Motion Sickness | 0 | 1 |
| Tinnitus | 0 | 1 |
| Diarrhoea | 0 | 2 |
| Abdominal Pain | 0 | 2 |
| Nausea | 0 | 2 |
| Vomiting | 0 | 1 |
| Lip Swelling | 0 | 1 |
| Oral Pruritis | 0 | 1 |
| Pyrexia | 0 | 2 |
| Injection Site Bruising | 1 | 1 |
| Fatigue | 0 | 1 |
| Nasopharyngitis | 0 | 2 |
| Laryngitis | 0 | 1 |
| Sinusitis | 0 | 1 |
| Upper Respiratory Tract Infection | 1 | 0 |
| Pharyngitis Streptococcal | 1 | 1 |
| Gastroenteritis | 0 | 1 |
| Otitis Media | 0 | 1 |
| Localised Infection | 0 | 1 |
| Anorexia | 0 | 1 |
| Arthralgia | 1 | 0 |
| Loss of Consciousness | 0 | 1 |
| Headache | 0 | 1 |
| Migraine | 0 | 1 |
| Dizziness | 0 | 1 |
| Hypoaesthesia | 0 | 1 |
| Menstruation Irregular | 1 | 0 |
| Cough | 0 | 3 |
| Nasal Congestion | 0 | 2 |
| Rhinitis Allergic | 1 | 0 |
| Asthma | 0 | 2 |
| Pharyngolaryngeal Pain | 0 | 2 |
| Rhinorrhoea | 0 | 1 |
| Throat Irritation | 0 | 1 |
| Eczema | 1 | 1 |
| Rash | 0 | 1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omalizumab (Placebo in Q2788g) | — | 0/4 (0%) | 3/4 (75%) |
| Omalizumab (Omalizumab in Q2788g) | — | 1/7 (14.3%) | 6/7 (85.7%) |
| Event | Omalizumab (Placebo in Q2788g) | Omalizumab (Omalizumab in Q2788g) |
|---|---|---|
| DepressionPsychiatric disorders | 0/4 | 1/7 |
| OverdoseInjury, poisoning and procedural complications | 0/4 | 1/7 |
| Event | Omalizumab (Placebo in Q2788g) | Omalizumab (Omalizumab in Q2788g) |
|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 0/4 | 3/7 |
| Abdominal PainGastrointestinal disorders | 0/4 | 2/7 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/4 | 2/7 |
| DiarrhoeaGastrointestinal disorders | 0/4 | 2/7 |
| Nasal CongestionRespiratory, thoracic and mediastinal disorders | 0/4 | 2/7 |
| NasopharyngitisInfections and infestations | 0/4 | 2/7 |
| NauseaGastrointestinal disorders | 0/4 | 2/7 |
| Pharyngolaryngeal PainRespiratory, thoracic and mediastinal disorders | 0/4 | 2/7 |
| PyrexiaGeneral disorders | 0/4 | 2/7 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/4 | 0/7 |
| Age, Customized(participants) | Omalizumab (Placebo in Q2788g) | Omalizumab (Omalizumab in Q2788g) | Total |
|---|---|---|---|
| 6 to < 12 Years | 0 | 2 | 2 |
| >= 12 Years | 4 | 5 | 9 |
| Age, Continuous(years) | Omalizumab (Placebo in Q2788g) | Omalizumab (Omalizumab in Q2788g) | Total |
|---|---|---|---|
| Mean | 32.0 ± 23.5 | 17.3 ± 8.9 | 22.6 ± 16.4 |
| Sex: Female, Male(Participants) | Omalizumab (Placebo in Q2788g) | Omalizumab (Omalizumab in Q2788g) | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 2 | 5 | 7 |
No study locations are listed for this record.
The record gives a start of Nov 2006, a primary completion of Jun 2008 and a completion of Jun 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2009, 1 year 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omalizumab