Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
Summary
This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 1 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may be allergic to more than two other foods, the primary endpoint/outcome in this study will only be assessed in peanut and two other foods for each participant. The primary objective of the study is to compare the ability to consume foods without dose-limiting symptoms during a double-blind placebo-controlled food challenge (DBPCFC), after treatment with either omalizumab or placebo for omalizumab.
Timeline
- Start
- 2019-07-22
- Primary completion
- 2023-03-13
- Completion
- 2025-07-01
Outcome
Met primary endpoint
registry analysis (superiority test); Omalizumab vs Placebo for Omalizumab; p <0.00001; Odds Ratio (OR) 27.853 (95% CI 9.1274 to 111.2144) reads as unknown NCT03881696 ↗
paper 79 of the 118 participants (67%) receiving omalizumab met the primary end-point criteria, as compared with 4 of the 59 participants (7%) receiving placebo reads as unknown PMID 38407394 ↗
release “determined the study met its primary endpoint and key secondary endpoints.” reads as met primary endpoint gene.com ↗
release “Interim analysis results from first-of-its-kind Phase III OUtMATCH study showed Xolair significantly increased the amount of peanut” reads as met primary endpoint gene.com ↗
release “the study met its primary endpoint showing 36% of food allergy patients treated with Xolair monotherapy could tolerate at least 2,000 mg of peanut protein” reads as met primary endpoint gene.com ↗
release “These interim results showed that, compared to placebo, Xolair significantly increased the amount of peanut (primary endpoint)” reads as met primary endpoint roche.com ↗
release “In the first head-to-head trial comparing Xolair to OIT, the study met its primary endpoint showing 36% of food allergy patients treated with Xolair monotherapy” reads as met primary endpoint gene.com ↗
Publications
- Background Sampson HA, Berin MC, Plaut M, Sicherer SH, Jones S, Burks AW, Lindblad R, Leung DYM, Wood RA. The Consortium for Food Allergy Research (CoFAR): The first generation. J Allergy Clin Immunol. 2019 Feb;143(2):486-493. doi: 10.1016/j.jaci.2018.12.989. Epub 2018 Dec 23.
- Results Wood RA, Togias A, Sicherer SH, Shreffler WG, Kim EH, Jones SM, Leung DYM, Vickery BP, Bird JA, Spergel JM, Iqbal A, Olsson J, Ligueros-Saylan M, Uddin A, Calatroni A, Huckabee CM, Rogers NH, Yovetich N, Dantzer J, Mudd K, Wang J, Groetch M, Pyle D, Keet CA, Kulis M, Sindher SB, Long A, Scurlock AM, Lanser BJ, Lee T, Parrish C, Brown-Whitehorn T, Spergel AKR, Veri M, Hamrah SD, Brittain E, Poyser J, Wheatley LM, Chinthrajah RS. Omalizumab for the Treatment of Multiple Food Allergies. N Engl J Med. 2024 Mar 7;390(10):889-899. doi: 10.1056/NEJMoa2312382. Epub 2024 Feb 25.
- Sindher SB, Chehade M, Dellon ES, Jones SM, Spergel JM, Lin A, Rogers NH, Wood RA, Shreffler WG, Burk CM, Kim EH, Virkud YV, Scurlock AM, Lanser BJ, Hui-Beckman JW, Vickery BP, Bird JA, Parrish C, Wang J, Sicherer SH, Brown-Whitehorn T, Dantzer J, Ruiz J, Wheatley LM, Chinthrajah RS. Management of Gastrointestinal Symptoms During Oral Immunotherapy: Guidance from OUtMATCH Investigators. J Allergy Clin Immunol Pract. 2026 Apr;14(4):772-779. doi: 10.1016/j.jaip.2026.01.011. Epub 2026 Feb 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cashew | Unknown | — | Oral |
| Subject | Egg | Unknown | — | Oral |
| Subject | Hazelnut | Unknown | — | Oral |
| Subject | Milk | Unknown | — | Oral |
| Subject | Omalizumab | Monoclonal antibody | — | Subcutaneous |
| Subject | Peanut Flour | Protein / enzyme biologic | — | Oral |
| Subject | Walnut | Unknown | — | Oral |
| Subject | Wheat | Unknown | — | Oral |