NCT03679676

Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE)

Phase 2 Randomized Controlled Trial Using Biologics to Improve Multi OIT Outcomes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 4 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Food allergy (FA) 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, single-center, multi-allergen OIT study in participants with proven allergies to 2 or 3 different foods in which one must be a peanut. The total of participants in the clinical study will be 110, 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 FA-specific IgE levels and 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 (444 mg cumulative) dosing level of FA proteins.

Detailed description

This is a prospective Phase 2, single-center, multi-allergen OIT study in participants with proven allergies to 2 or 3 different foods in which one must be peanut. The total population will be 110 participants, ages 4 to 55 years that present with a history of multiple food allergies of 2 or 3 different foods including peanut, food-allergen (FA)-specific IgE levels, and positive skin prick test (SPT). Enrolled participants must react positively during DBPCFCs at or before the 300 mg (444 mg cumulative) dosing level of FA proteins of 2 or 3 allergens in which one must be a peanut. There will be three study cohorts, all will be double blinded: Cohort A (50 participants) will be treated with omalizumab for 8 weeks followed by 24 weeks of treatment with placebo. Cohort B (50 participants) will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with dupilumab. Cohort C (10 participants) will be treated with placebo for 8 weeks followed by 24 weeks treatment with dupilumab. All cohorts will receive multifood allergen oral immunotherapy.

Conditions

• Hypersensitivity
• Food Allergy
• Hypersensitivity, Food
• Peanut Hypersensitivity
• Peanut Allergy

Interventions

Type	Name	Description
DRUG	Omalizumab	Omalizumab is injected every 2 to 4 weeks
DRUG	Dupilumab	Dupilumab is injected every 2 weeks combination, or placebo.
OTHER	Placebo	Placebo is injected every 2 to 4 weeks

Timeline

• Start date: 2020-02-05
• Primary completion: 2025-04-15
• Completion: 2025-05-02
• First posted: 2018-09-20
• Last updated: 2025-05-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study