Actively Recruiting
Omalizumab Weight-Based Dosing Efficacy Trial
Led by Massachusetts General Hospital · Updated on 2026-02-05
30
Participants Needed
3
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.
CONDITIONS
Official Title
Omalizumab Weight-Based Dosing Efficacy Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Positive skin prick test with a wheal 6 mm or larger to at least two relevant foods (peanut, cashew, walnut, egg, or milk)
- Positive food-specific IgE level of 2.0 kUA/L or higher to at least two relevant foods
- History of allergic reaction to at least one qualifying food other than the challenge food
- Positive oral food challenge to one qualifying food at a cumulative dose of 144 mg or less (maximum tolerated dose 30 mg)
You will not qualify if you...
- Weight over 80 kg at screening
- Clinically significant lab abnormalities at screening
- Allergy or suspected allergy to omalizumab or its ingredients
- Poorly controlled or severe asthma or wheezing at screening
- History of severe anaphylaxis to study foods with neurological compromise or intensive care admission
- Use of oral, IM, or IV steroids for more than 2 days (except for asthma/wheezing) within 30 days before screening
- Current use of oral, IM, or IV corticosteroids, tricyclic antidepressants, or beta-blockers
- Past or current eosinophilic gastrointestinal disease within 3 years
- Past or current history of cancer or under investigation for cancer
- Food immunotherapy within 6 months before screening
- Monoclonal antibody or immunomodulatory therapy within 6 months before screening
- Inability to stop antihistamines for required washout periods before tests
- Pregnant, breastfeeding, or planning pregnancy during the study
- Presence of clinically significant chronic disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
3
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
J
Jannat Gill
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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