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.

Timeline

Start

2020-02-05

Primary completion

2025-04-15

Completion

2025-05-02

Publications

• Results Long AJ, Sindher S, Martinez K, Choi JH, Albarran M, Schuetz J, Parry A, Tang J, Garcia Llorett M, Zedeck SS, Grissinger A, Kiernan E, Leonard S, Raeber O, Feight C, Anderson B, Sharma R, Bogetic D, Chin AR, Woch M, Poyser J, Laurienzo Panza J, Togias A, Wheatley L, Boyd S, Galli SJ, Nadeau KC, Chinthrajah RS. A phase 2 randomized controlled trial using biologics to improve multi OIT outcomes (COMBINE): design, rationale, and methods. Front Allergy. 2025 Dec 18;6:1729111. doi: 10.3389/falgy.2025.1729111. eCollection 2025.
• Ghelli C, Costanzo G, Canonica GW, Heffler E, Paoletti G. New evidence in food allergies treatment. Curr Opin Allergy Clin Immunol. 2024 Aug 1;24(4):251-256. doi: 10.1097/ACI.0000000000000999. Epub 2024 May 30.

Drugs

Indications