Food allergy (FA) is a significant public health issue that causes potentially life-threatening reactions. This study explores whether suppression of allergic responses by anti-IgE followed by the combination of oral immunotherapy (OIT) with IL4Ra blockade will increase the ability to sustain clinical tolerance in the absence of continued therapy. 

This is a prospective Phase 2, multi-center study, multi-allergen OIT study in participants with proven allergies to 2 or 3 different foods in which one must be peanut. The target number of total participants is 110, ages 4 to 55 years. FA is confirmed through sIgE levels, skin prick tests (SPT) and a positive Double-blind Placebo-controlled Food Challenge (DBPCFC) at 300 mg or lower dose of protein for each food. The study consists of 3 cohorts: Cohort A (n=50) treated with omalizumab for 8 weeks followed by 24 weeks of placebo. Cohort B (n=50) treated with omalizumab for 8 weeks, followed by 24 weeks of dupilumab. Cohort C (n=10) treated with placebo for 8 weeks followed by 24 weeks of dupilumab. All cohorts receive multifood allergen OIT.

Blinded safety data from 108 participants (as of July 2024) are presented. Adverse events (AEs), defined as any unfavorable medical occurrence associated with the use of the intervention, whether or not considered intervention related, were reported in 93% of subjects. Allergic AEs occurred in 37% of participants. Of the allergic AEs, 60% were CoFAR Grade 1, 16% Grade 2, and 25% Grade 3, with no Grade 4 or 5 events. Non-allergic AEs were reported in 15% of subjects, mostly mild (72%) or moderate (28%). No severe non-allergic AEs were observed. Two serious allergic adverse events (SAEs) were observed resulting in withdrawal from the study, one at week 8 and the other at week 44. Both cases resolved with epinephrine and no lasting effects.

These blinded safety data from a trial involving multi-food OIT and two biologics do not raise concerns, but unblinding at the end of the trial will provide more specific information.