Novartis advances ligelizumab (QGE031) in urticaria to Phase III on basis of strong Phase II head-to-head data

Novartis announced the initiation of Phase III trials for ligelizumab (QGE031) – a high-affinity monoclonal anti-IgE antibody – in chronic spontaneous urticaria (CSU) patients whose symptoms are inadequately controlled by H1-antihistamines. Phase III studies PEARL1 and PEARL 2 are planned to include more than 2,000 CSU patients.

“CSU has a big impact on patients’ lives,” said Marcus Maurer, MD, Professor of Dermatology and Allergy and Director of Research at the Department of Dermatology and Allergy, Allergie-Centrum-Charité of the Charité-Universitätsmedizin in Berlin, Germany. “Despite existing treatment options, too many people continue to struggle with the debilitating and potentially painful symptoms of CSU. Advancing ligelizumab to Phase III is encouraging news for physicians and patients who have difficulty in controlling symptoms.”

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

“Novartis is committed to leveraging our strong heritage and expertise in immuno-dermatology to reimagine and discover potential new treatments which can benefit patients,” said Eric Hughes, Global Development Unit Head, Immunology, Hepatology and Dermatology. “By initiating ligelizumab to Phase III studies we continue to honor that commitment.”

The purpose of Phase III studies PEARL 1 and PEARL 2 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. Both trials are multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group studies in 48 countries including the US, Germany and Japan.