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Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE)
Sponsor: Stanford University
Summary
Food allergy is a serious public health concern that causes potentially-life threatening reactions in affected patients. The prevalence of food allergy in the United States (U.S.) has increased substantially and now affects 15 million patients:4-8% of children (6 million children, 30% with multiple food allergies) and about 9% of adults. This is a prospective Phase 2, multi-center, multi-allergen OIT study in participants with proven allergies to 2 or 3 different foods in which one must be peanut. The intent-to-treat population in the clinical study will be 110 participants, ages 4 to 55 years with a history of multiple food allergies of 2 to 3 different foods including peanut. Allergy will be confirmed by food allergen (FA)-specific Immunoglobulin E (IgE) levels or positive Skin Prick Test (SPT). Enrolled participants must be positive during the Double-blind Placebo-controlled Food challenge (DBPCFC) at or before the 300 mg protein (444 mg cumulative) dosing level of FA proteins.
Official title: Phase 2 Randomized Controlled Trial Using Biologics to Improve Multi OIT Outcomes
Key Details
Gender
All
Age Range
4 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2020-02-05
Completion Date
2025-05-02
Last Updated
2026-05-29
Healthy Volunteers
No
Interventions
Omalizumab
Omalizumab is injected every 2 or 4 weeks
Dupilumab
Dupilumab is injected every 2 or 4 weeks combination, or placebo.
Placebo for Dupilumab
Placebo for dupilumab is injected every 2 or 4 weeks
Placebo for Omalizumab
Placebo for omalizumab is injected every 2 or 4 weeks
Locations (3)
University of California Los Angeles (UCLA)
Los Angeles, California, United States
Sean N. Parker Center for Allergy & Asthma Research at Stanford University
Palo Alto, California, United States
University of California San Diego (UCSD)
San Diego, California, United States