Policy & Regulation
Novartis starts phase three trials for ligelizumab
6 December 2018 -

Switzerland-based Novartis has started phase three trials for its monoclonal anti-IgE antibody (ligelizumab) in chronic spontaneous urticarial (CSU) patients whose symptoms are inadequately controlled by H1-antihistamines, it was reported yesterday.

Phase three studies PEARL one and PEARL two are planned to include more than 2,000 CSU patients. The main aim of the Phase III studies is to establish efficacy and safety of ligelizumab in adolescent and adult patients >= 12 years of age with CSU who remain symptomatic despite the use of H1-antihistamines.

Results from the placebo- and active-controlled Phase IIb trial indicated that the product met the primary endpoint by showcasing a clear dose-response relationship, and improvements over Xolair (omalizumab) in CSU patients. The product achieved rapid onset of action and improved and sustained efficacy in patients, whose symptoms are not adequately controlled by H1-antihistamines.

Both trials are multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group studies in 48 countries including the US, Germany and Japan.