The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, has partnered with Genentech (Roche) and Novartis to conduct a new study to evaluate an experimental treatment for food allergies.
More than 4.8 million children in the United States suffer from food allergies. Not one approved preventative treatment exists. Although experimental desensitization strategies are present 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.
Called Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergan Oral Immunotherapy in Food Allergic Children and Adults, or OUtMATCH, the study 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.
Research Site network: Consortium of Food Allergy Research (CoFAR)
The NIAID-supported Consortium of Food Allergy Research (CoFar) will conduct OUtMATCH at 10 clinical sties throughout the United States. The study aims to enroll 225 patients ages 2 to less than 56 with am allergy to peanuts and at least two other foods, such as cow’s milk, egg whites, wheat, cashews, hazelnuts, or walnuts. Rho Federal Systems Division Inc., will serve as the Statistical and Clinical Coordinating Center.
Omalizumab, sold under the trade name Xolair, is a medication originally designed to reduce sensitivity to allergens. It has been used to try to control severe allergic asthma, which does not respond to high doses of corticosteroids and less widely for chronic spontaneous urticaria.
Omalizumab is a manufactured antibody that reduces immunoglobulin E (IgE). IgE is a class of human antibodies that trigger reactions to allergens, including certain foods. These reactions can progress to dangerous airway constriction and a sudden drop in blood pressure—symptoms of a life-threatening reaction known as anaphylaxis. Last year, the FDA granted Breakthrough Therapy Designation for omalizumab for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies.Source: National Institutes of Health