What this study is
The goal of this clinical trial is to learn how quickly omalizumab begins to work in people with food allergy. The main question it aims to answer is:
- Does omalizumab begin to work as early as 2 to 4 weeks after after starting treatment in people with food allergy?
Researchers will compare each participant's food challenge results at baseline before starting omalizumab, 2 to 4 weeks after starting omalizumab, and 4 to 6 months after starting omalizumab treatment.
Participants will:
- Have a baseline food challenge before starting omalizumab.
- Start omalizumab treatment as prescribed by the participant's doctor as part of regular clinical care.
- Have food challenges 2 to 4 weeks after starting omalizumab and again 4 to 6 months after starting omalizumab.
- Have skin prick testing and blood tests at study visits.
What's being tested
- Omalizumab
Intervention · DRUG
Prior to starting omalizumab, participants will undergo a baseline oral food challenge. Participants will then initiate omalizumab treatment as prescribed by their doctor as part of routine clinical care. After 2 to 4 weeks of treatment (following one to two doses of omalizumab), participants will undergo a first post-treatment oral food challenge to assess treatment response. After 4 to 6 months of omalizumab treatment, participants will undergo a second post-treatment oral food challenge. The study will conclude following the second post-treatment oral food challenge.
Study details
- Sponsor
- Johns Hopkins University
- Conditions
- Food Allergy
- Enrolling
- 20 people
- Starts
- 2026-10-19
- Est. completion
- 2028-10
- Design
- Open-label, single group, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 1 Year – 30 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openJohns Hopkins Hospital
Baltimore, Maryland, United States
- Kim Mudd · Contact410-955-5883kmudd2@jhmi.edu
- Robert Wood, MD · Contact410-955-5883rwood@jhmi.edu
- Robert Wood, MD · Principal investigator
Recruiting
Study team
Sponsor
Johns Hopkins University
Study ID IRB00570914
Principal investigator
Robert Wood, MD
Johns Hopkins University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.