At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Randomized Controlled Trial Using Biologics to Improve Multi OIT Outcomes
In Brief
A Phase 2 clinical trial evaluating Omalizumab, Dupilumab, and 2 other interventions for Hypersensitivity and 4 related conditions. Completed, enrolled 130 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
Omalizumab is injected every 2 or 4 weeks
Dupilumab is injected every 2 or 4 weeks combination, or placebo.
Placebo for dupilumab is injected every 2 or 4 weeks
Placebo for omalizumab is injected every 2 or 4 weeks