Oral Food Challenge After Starting Omalizumab in Food Allergy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 interventional study looks at the early and longer-term effects of omalizumab on food allergy. Researchers compare baseline food challenges with results at 2–4 weeks and again at 4–6 months after initiating omalizumab, alongside skin tests and blood tests. Participants are children and young adults with diagnosed food allergies who are already receiving omalizumab as part of their regular care at Johns Hopkins. The study uses open oral food challenges to assess changes in reaction thresholds over time. Eligibility requires documented allergy to common foods and a positive IgE or skin-prick test, with insurance authorization in place.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 1 to 30 years.
* Patients with diagnosed food allergy to at least one of the following foods (milk, egg, wheat, peanut, cashew, or walnut) who were prescribed omalizumab for food allergy in the clinical setting at the Johns Hopkins pediatric or adult allergy clinic.
* Positive food-specific IgE (≥2.0 kUA/L) to the relevant food OR a positive skin-prick test with a wheal ≥4 mm larger than the saline control.
* Positive open oral food challenge at baseline screening evaluation to the relevant food with dose-limiting symptoms at a single dose of ≤1000 mg (cumulative dose of ≤2043 mg) prior to starting omalizumab (using incremental doses of 3, 10, 30, 100, 300, 600, 1000 mg).
* Prior authorization from the patient's insurance provider for clinical use of omalizumab.

Exclusion Criteria:

* Clinically significant laboratory abnormalities in the past 6 months.
* Sensitivity or suspected/known allergy to any ingredients (including excipients) of omalizumab
* Poorly controlled or severe asthma/wheezing at screening
* History of severe anaphylaxis to the participant-specific food that will be used in this study, defined as neurological compromise or requiring intubation.
* Currently receiving oral, intramuscular (IM), or intravenous (IV) corticosteroids, tricyclic antidepressants, or β-blockers.
* Past or current history of cancer, or currently being investigated for possible cancer.
* Past or current history of any food immunotherapy, such as oral immunotherapy (OIT), sublingual immunotherapy (SLIT), epicutaneous immunotherapy (EPIT) within 6 months of screening.
* Treatment with monoclonal antibody therapy, such as omalizumab, dupilumab, benralizumab, mepolizumab, reslizumab, tezepelumab, or other immunomodulatory therapy within 6 months of screening.
* Inability to discontinue antihistamines for minimum wash-out periods required for skin-prick test or oral food challenge.
* Pregnant or breastfeeding, or intending to become pregnant during the study
* Evidence of clinically significant chronic disease.

Where it's running

• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Robert Wood, MD — Johns Hopkins University
• Study coordinator: Hao Tseng, MD
• Email: htseng9@jh.edu
• Phone: 410-955-5883

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.