OUtMATCH: A Life-Changing Trial for People with Food Allergies

April 1, 2025

The OUtMATCH trial is a pivotal study for the treatment of food allergy and was conducted by the CoFAR network.

When the study began, Xolair (omalizumab) was approved only for patients with allergic asthma or chronic hives. Using the information that we learned from the trial, the FDA approved Xolair as a treatment to protect patients as young as 1 year from food allergic reactions, including anaphylaxis, which can occur when they accidentally eat foods that they are allergic to.

The OUtMATCH study was separated into three stages. Stage 1 of the trial is the stage that supported the Xolair approval described above. In this stage, study participants with food allergies were randomized 2:1 to receive either Xolair or placebo for up to 20 weeks. Then, these participants completed four supervised sessions where they attempted to eat the food they are allergic to, called an oral food challenge. During each challenge, participants tried to eat more and more of the food that they were allergic to. After treatment, participants were able to tolerate much higher amounts of food they were allergic to without having allergic reactions!

You can learn more about the study in its ClinicalTrials.gov page. The paper describing the results in full was published in the New England Journal of Medicine, and a summary can be found here on NIH PubMed.

In Stages 2 and 3, the OUtMATCH team continues to learn more about the treatment of food allergy. We look forward to the ongoing work and to sharing more data as they become available!

Shining Even Brighter in SUNBEAM II

January 1, 2025

It's official: SUNBEAM II is here!

The Systems Biology of Early Atopy (CoFAR-12/SUNBEAM) is a large study designed to look at how and why food allergies and atopic dermatitis (eczema) develop in early life. Right now, we don't know which babies are most likely to develop food allergies and eczema. The SUNBEAM study will use advanced technology to study genes, the immune system, and gut microbes and look for early warning signs (biomarkers) and biological patterns that lead to food allergy or eczema. This could help create better, more personalized ways to prevent allergies in the future.

In SUNBEAM, pregnant women are enrolled prior to delivery of their babies and both they and the future fathers provide samples and data to the study. After the baby is born, study teams continue to collect samples and data from the newborn child, as well as the mother and father. Originally, the study planned to work with these families until their child turned 3 years old. As of June 2025, the SUNBEAM team is excited to announce that with "SUNBEAM II," the study will continue for three more years, through age 6!

For existing study participants, SUNBEAM II will be more of the same study you've come to know and love! We will continue to see participants in clinic, but only annually for this section of the study. We will continue with home sample collection and surveys. We will also be able to incorporate some new procedures into clinic visits to learn more about asthma as the children get older. Talk to your clinical site team to learn more and thank you for helping us learn more about allergic diseases!