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COMPLETED
NCT03679676
PHASE2

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

Sponsor: Stanford University

View on ClinicalTrials.gov

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

DRUG

Omalizumab

Omalizumab is injected every 2 or 4 weeks

DRUG

Dupilumab

Dupilumab is injected every 2 or 4 weeks combination, or placebo.

OTHER

Placebo for Dupilumab

Placebo for dupilumab is injected every 2 or 4 weeks

OTHER

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