Abstract
BACKGROUND: The growing burden of food allergy globally has been accompanied by increasing demand for effective treatments. Ligelizumab is a humanised anti-IgE monoclonal antibody that can strongly inhibit allergic pathways. This phase 3 study evaluated the efficacy and safety of ligelizumab in participants with confirmed IgE-mediated peanut allergy.
METHODS: This was a 52-week, multicentre, randomised, double-blind, placebo-controlled study in adults and adolescents with confirmed peanut allergy. Participants received either ligelizumab 120 mg or 240 mg or placebo subcutaneously every 4 weeks. The primary endpoint was the proportion of participants tolerating ≥ 600 mg of peanut protein without dose-limiting symptoms during a double-blind, placebo-controlled, food challenge at week 12. Secondary endpoints included tolerance to higher doses of peanut protein. However, the study was terminated early due to evidence from blinded data reviews that the target efficacy would not be met. All participants enrolled at the time of termination could complete week 12 assessments.
RESULTS: The primary endpoint was met in the ligelizumab 240 mg treatment arm, with 44.7% (21/47) of participants tolerating ≥ 600 mg of peanut protein versus 4.3% (1/23) for placebo. Numerically higher efficacy was observed in the ligelizumab 120 mg treatment arm (15.7% [8/51]) versus placebo. Positive dose-dependent trends were observed across the key secondary endpoints, but statistical significance, per the pre-planned testing strategy, was not achieved. Safety profiles were consistent with known data, with no new safety signals observed.
CONCLUSIONS: Ligelizumab 240 mg demonstrated clinical superiority over placebo, with favourable tolerability, in treating IgE-mediated peanut allergy, despite early termination of the study.