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

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.

Conditions

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

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Food Allergy Research & Education

  collaborator OTHER

• Harvard School of Public Health (HSPH)

  collaborator OTHER

• Stanford University

  lead OTHER

Principal Investigators

• Rebecca S Chinthrajah, M.D. · Sean N Parker Center for Allergy and Asthma Center at Stanford

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-05

Primary Completion

2025-04-15

Completion

2025-05-02

FDA Drug

Yes

Countries

• United States

Study Locations