Food allergy treatment could enter a new phase as researchers prepare to test whether combining powerful immune-modulating drugs with traditional oral immunotherapy can overcome the dose-limiting side effects that plague current approaches. This represents a potential breakthrough for the millions suffering from multiple food allergies who currently face limited treatment options.
The COMBINE trial will evaluate omalizumab and dupilumab—biologics already approved for asthma and eczema—alongside multi-food oral immunotherapy in 110 participants aged 4-55 with multiple food allergies including peanut. Participants receive either omalizumab alone, both biologics together, or placebo, all combined with gradual exposure to their specific allergens. The primary endpoint measures successful desensitization to at least 1,043 mg of cumulative protein after 32 weeks, equivalent to consuming about four peanuts worth of allergen.
This approach addresses a critical limitation in current food allergy treatment. While oral immunotherapy can desensitize patients to specific foods, up to 20% discontinue due to gastrointestinal symptoms, eczema flares, or systemic reactions. Omalizumab blocks IgE antibodies responsible for immediate allergic reactions, while dupilumab inhibits IL-4 and IL-13 pathways driving chronic inflammation. The combination could theoretically suppress both immediate and delayed hypersensitivity reactions.
The trial design reflects growing sophistication in allergy therapeutics, moving beyond single-target approaches toward comprehensive pathway modulation. However, the complexity of managing multiple biologics alongside food challenges will require careful safety monitoring. If successful, this multi-modal strategy could establish a new standard of care, potentially allowing patients to achieve tolerance to multiple foods simultaneously while minimizing treatment-related adverse events.