Ligelizumab, an investigational treatment for chronic spontaneous urticaria (CSU), failed to show superiority to omalizumab in two identical phase 3 trials.
Ligelizumab is a high-affinity monoclonal anti-immunoglobulin E (IgE) antibody. It was assessed in the PEARL 1 (ClinicalTrials.gov Identifier: NCT03580369) and PEARL 2 (ClinicalTrials.gov Identifier: NCT03580356) trials, which included more than 2000 participants 12 years and older with CSU. Both trials were double-blind, parallel-group, active- and placebo-controlled.
Patients were randomly assigned to receive ligelizumab 72mg, ligelizumab 120mg, omalizumab 300mg, or placebo every 4 weeks for 1 year. The primary endpoint was change from baseline in Urticaria Activity Score over 7 days (UAS7) at week 12. Results showed that ligelizumab met the primary endpoint demonstrating superiority compared with placebo, but not vs omalizumab.
Complete data from the trial will not be available until the second half of 2022, according to the manufacturer, Novartis. John Tsai, MD, CMO of Novartis said, “We will continue to evaluate the potential for ligelizumab to bring benefit to patients in the areas of chronic inducible urticaria (CIndU) and food allergy, where there is significant unmet need.”
The Company is also investigating remibrutinib, (LOU064) a potent oral BTK inhibitor, for CSU disease control in two phase 3 trials (ClinicalTrials.gov Identifier: NCT05030311 and NCT05032157).
Novartis provides an update on Phase III ligelizumab (QGE031) studies in chronic spontaneous urticaria (CSU). News Release. Accessed December 20, 2021. https://www.globenewswire.com/news-release/2021/12/20/2354923/0/en/Novartis-provides-an-update-on-Phase-III-ligelizumab-QGE031-studies-in-chronic-spontaneous-urticaria-CSU.html.