Actively Recruiting
Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels
Led by Johns Hopkins University · Updated on 2025-06-05
32
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 have a total immunoglobulin E (IgE) above the current FDA approved dosing regimen enabling a person to increase tolerance to the food(s) that the person is allergic to. The investigators would also like to learn if participants who demonstrate increased tolerance to food after 24 weeks of omalizumab, can introduce the food into the diet utilizing an additional 8 weeks (about 2 months) of twice weekly omalizumab injections.
CONDITIONS
Official Title
Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 1 to 55 years
- Positive skin prick test with a wheal of 6 mm or more to at least one relevant food (peanut, cashew, walnut, egg, milk, or wheat)
- Positive food-specific IgE of 2.0 kUA/L or higher to at least one study food
- Weight and IgE level that exclude participation in the OUTMATCH study based on dosing guidelines
- Positive double-blind, placebo-controlled food challenge to a relevant food with cumulative dose of 144 mg or less (maximum tolerated dose 30 mg)
You will not qualify if you...
- Clinically significant laboratory abnormalities at screening
- Dose-limiting symptoms during blinded placebo food challenge at screening
- Poorly controlled or severe asthma or wheezing at screening
- History of severe anaphylaxis to study foods defined as neurological compromise or requiring intubation
- Treatment with oral, IM, or IV steroids for more than two days (except for asthma/wheezing) within 30 days of screening
- Current use of oral, IM, or IV corticosteroids, tricyclic antidepressants, or beta-blockers
- Past or current eosinophilic gastrointestinal disease within three years
- Past or current history of cancer or current cancer investigation
- Past or current food immunotherapy within six months
- Treatment with monoclonal antibody or other immunomodulatory therapy within six months
- Inability to stop antihistamines for necessary wash-out periods
- Pregnant, breastfeeding, or planning pregnancy during the study
- Evidence of clinically significant chronic disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
R
Robert Wood, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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