Food Allergy & Anaphylaxis
Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants (OUtMATCH)
Brief 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.
Omalizumab is a medication approved to treat people whose asthma is not well controlled with the usual prescription medications. It is also approved to treat people who have chronic, unexplained hives. Omalizumab is not approved to treat food allergies, but the FDA has allowed it to be used in this research study.
By participating in the OUtMATCH clinical trial, you will have the opportunity to help researchers test new treatments that can help reduce food allergies. If you think you, or someone you know might be eligible, speak with your doctor, consider participating, and spread the word about the trial.
Visit ClinicalTrials.gov for all details.
