A Phase 4 interventional study of Omalizumab Injection in Food Allergy and Food Allergy in Children, sponsored by National Jewish Health. Recruiting at 1 site in United States. Open to participants aged 1 Year to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-02.
Sponsored by National Jewish Health · Phase 4, Interventional, and Basic science
The goal of this interventional study is to evaluate whether skin barrier abnormalities occur in subjects with a food allergy, as determined by positive oral food challenge (OFC). The main question it aims to answer is whether these skin barrier abnormalities can be reversed by omalizumab.
If there is a comparison group: Researchers will compare non-food allergic participants (who do not receive omalizumab) to see if they experience skin barrier abnormalities.
All food allergic participants will receive 4 months of Omalizumab treatment as well as two Oral Food Challenges. Participants will all undergo skin barrier assessments.
This is a phase IV open-label interventional pilot study of 30 patients enrolled at National Jewish Health to examine skin barrier function and response to OFC in patients with FA before and after 4 months of treatment with omalizumab. If enrollment is insufficient at National Jewish, Children's Hospital Colorado or another similarly qualified site will be used as a back-up site. Efficacy assessment will be assessed by the ability of Omalizumab to reduce clinical response to OFC. The safety of omalizumab will be concomitantly recorded. Specifically, we will:
Sample size will be 30 completed subjects. Enrollment will occur over the course of 16 months, with 2-4 participants enrolling each month. Up to ten healthy control subjects will also be enrolled for skin tape strip analysis and TEWL as a comparator group to the FA group.
All participants will have an initial screening visit where their clinical history of having an IgE-mediated reaction to specified food(s) will be elucidated, along with review of relevant skin prick test (SPT), food-specific IgE values, and Total IgE. If these values were not obtained within the last 12 months, SPT, sIgE, and/or Total IgE will be performed at screening. All food-allergic participants will undergo an open Screening OFC to one of their food allergens. For continuation in the study, the participant must experience dose-limiting symptoms consistent with an IgE-mediated reaction, at or before 444mg of food protein cumulatively. If they have a negative OFC, additional screening OFCs may be performed to any eligible food. STS and TEWL measurements will be performed prior to the first dose, as well as before the second and third doses. If/when the participant has dose-limiting symptoms, STS and TEWL will be stopped immediately.
All food-allergic participants will receive omalizumab for 4 months. All injections will be administered by a research nurse on the clinical research unit. At the midway point of the study (2 months after the first omalizumab injection), the participant will have STS and TEWL measurements performed.
After 4 months of omalizumab administration, an end of study OFC will be performed to the same food that was positive at the screening OFC to assess treatment effect, along with analysis of the STS and TEWL.
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 246 interventional studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →National Jewish Health is the lead sponsor of 109 studies on the registry; 14 are open to participants now.
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.
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.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will receive 4 months of Omalizumab treatment, and undergo regular skin barrier assessments.
Drug: Omalizumab Injection
This group will undergo skin barrier assessment.
Omalizumab is a monoclonal antibody FDA-approved for treatment of food allergy.
Also known as: Xolair
Lipidomic analysis
Lipid measurements from Skin Tape Strips (STS), as detected at respective m/z from mass spectrometry
Time frame: 5 months
Metabolomic analysis
Metabolomics from STS, evaluated as a relative signal proportion of metabolites against the sum of all signals in the samples
Time frame: 5 months
Proteomic analysis
Proteomics from STS, comparison of global protein expression before vs after omalizumab treatment
Time frame: 5 months
Cytokine analysis
Cytokine levels from STS measured using preconfigured multiplex assays normalized to the total protein in each sample. Cytokines that will be measured: IL-1a, IL-1b, IL-18, IL-6, IL-8, TARC, MDC, TSLP, IL-33, IL-4, IL-13, IL-22, IL-31, eotaxins, IL-10, IL-17A/F, IL-17C, IL-12p70, IL-23, IP-10
Time frame: 5 months
Measurement of Transepidermal Water Loss
Transepidermal Water Loss (TEWL) is measured by the loss through the skin of grams of water per square meter per hour (g/m\^2/h).
Time frame: 5 months
Measurement of Transepidermal Water Loss in non Food-Allergic Subjects
Transepidermal Water Loss (TEWL), grams water per square meter per hour (g/m\^2/h)
Time frame: 5 months
Lipidomic analysis in non Food-Allergic participants
Lipid measurements from Skin Tape Strips (STS), as detected at respective m/z from mass spectrometry
Time frame: 5 months
Metabolomic analysis in non Food-Allergic Participants
Metabolomics from STS, evaluated as a relative signal proportion of metabolites against the sum of all signals in the samples
Time frame: 5 months
Proteomic analysis in non Food-Allergic Participants
Proteomics from STS, baseline expression levels of proteins found in non-allergic skin tapes.
Time frame: 5 months
Cytokine analysis
Cytokine levels from STS from non-Food Allergic participants, measured using preconfigured multiplex assays normalized to the total protein in each sample. Cytokines that will be measured: IL-1a, IL-1b, IL-18, IL-6, IL-8, TARC, MDC, TSLP, IL-33, IL-4, IL-13, IL-22, IL-31, eotaxins, IL-10, IL-17A/F, IL-17C, IL-12p70, IL-23, IP-10
Time frame: 5 months
Plan to share: No
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Studies of the drug tested here: Omalizumab