Novartis Terminates Second Phase III Trial of IgE Monoclonal Antibody Ligelizumab for Peanut Allergy

On January 16, the clinicaltrials.gov website showed that Novartis terminated the Phase III clinical trial (CQGE031G12301 study) of immunoglobulin E (IgE) monoclonal antibody Ligelizumab for the treatment of peanut allergy.

This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial that originally planned to enroll 486 patients medically diagnosed with IgE-mediated peanut allergy, aiming to evaluate the efficacy and safety of Ligelizumab (120/240mg, once monthly) compared to placebo. As of the trial termination date, the study had enrolled 211 patients.

This termination marks the second setback for Ligelizumab in the autoimmune field. In September 2023, Novartis officially halted the Phase III PEARL-PROVOKE study of Ligelizumab for the treatment of Chronic Inducible Urticaria (CIU). The reason was that the results obtained from two Phase III studies (PEARL 1 and PEARL 2) for the treatment of Chronic Spontaneous Urticaria (CSU) did not demonstrate significant therapeutic advantages.Ligelizumab is more effective than placebo but less effective than omalizumab.

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