Status:
RECRUITING
Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Food Hypersensitivity
Eligibility:
All Genders
1-55 years
Phase:
PHASE2
Brief Summary
In this project, the investigators would like to learn if 24 weeks (about 5 and a half months) of omalizumab injections, given every 2 weeks, will be safe and effective for food allergic people who ha...
Eligibility Criteria
Inclusion
- Age 1 to 55 years
- A positive prick skin test (PST) with a wheal ≥ 6 mm to at least one of the relevant foods (peanut, cashew, walnut, egg, milk, or wheat)
- Positive food-specific IgE (≥2.0 kilo units of allergen-specific IgE per liter (kUA/L)) to at least one of the study specific foods
- A weight / IgE level that would have excluded the participant from the OUTMATCH study based on the dosing table noted above
- Positive double-blind, placebo-controlled food challenge (DBPCFC) to one of the relevant foods at a cumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg)
Exclusion
- Clinically significant laboratory abnormalities at screening.
- Dose-limiting symptoms during the blinded food challenge to placebo during the screening DBPCFC.
- Poorly controlled or severe asthma/wheezing at screening
- History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise or requiring intubation.
- Treatment with a burst of oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma/wheezing within 30 days of screening.
- Currently receiving oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers.
- Past or current history of eosinophilic gastrointestinal disease within three years of screening.
- Past or current history of cancer, or currently being investigated for possible cancer.
- Past or current history of any food immunotherapy (e.g., 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 tests (SPTs) or oral food challenges (OFCs).
- Pregnant or breastfeeding, or intending to become pregnant during the study
- Evidence of clinically significant chronic disease.
Key Trial Info
Start Date :
May 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2027
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06934200
Start Date
May 19 2025
End Date
October 15 2027
Last Update
June 5 2025
Active Locations (1)
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1
Johns Hopkins
Baltimore, Maryland, United States, 21287