NIH and partners to assess Omalizumab effect on food allergy

Clinical trial to evaluate experimental treatment in people allergic to multiple foods

Though food allergy affects more than 4.8 million children in the United States, no approved preventative treatments currently exist. While experimental desensitization strategies are available in research settings, people with food allergies must avoid known allergens and are advised to carry injectable epinephrine to prevent potentially life-threatening allergic reactions caused by  accidental exposures.

To help alleviate this risk, a new study to evaluate an experimental treatment for food allergy has been launched. The study is supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health; Genentech, a member of the Roche Group; and Novartis Pharmaceuticals Corporation.

The study is called Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food Allergic Children and Adults, or OUtMATCH. It will test the ability of biweekly or monthly injections of omalizumab—alone or together with multi-allergen oral immunotherapy (OIT)—to increase a person’s ability to tolerate foods to which they are allergic.

Multi-allergen OIT involves consuming small, gradually increasing amounts of several allergens in a controlled setting to build the body’s tolerance to those food allergens. Investigators will assess whether the experimental treatment regimens help prevent allergic reactions to small amounts of food that may be consumed unintentionally, thereby mitigating the danger of life-threatening emergencies among people with multiple food allergies.

The NIAID-supported Consortium of Food Allergy Research, or CoFAR, will conduct OUtMATCH at 10 clinical sites throughout the United States. The study aims to enroll 225 participants ages 2 to less than 56 years with allergy to peanut and at least two other foods, such as cow’s milk, egg white, wheat, cashew, hazelnut or walnut. Rho Federal Systems Division, Inc., will serve as the Statistical and Clinical Coordinating Center.