Ligelizumab fails to show superiority to omalizumab in chronic spontaneous urticaria: Clinical trials
Ligelizumab, an investigational treatment for chronic spontaneous urticaria (CSU), failed to show superiority to omalizumab in two identical phase 3 trial.
Novartis today announced top-line results from PEARL 1 and PEARL 2 Phase III studies in chronic spontaneous urticaria (CSU), which showed that the studies met their primary endpoints of superiority for ligelizumab versus placebo at Week 12, but not versus omalizumab1.
"We are disappointed that we have been unable to demonstrate superior efficacy for ligelizumab versus standard of care in the treatment of CSU," said John Tsai, M.D., Head of Global Drug Development and Chief Medical Officer, Novartis. "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."
Full PEARL 1 and 2 Phase III data will be made publicly available after study completion in the second half of 2022.
Novartis recently began Phase III studies for remibrutinib (LOU064), a highly selective, potent oral BTK inhibitor that has previously shown rapid and effective CSU disease control8,9.
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