Novartis has initiated phase III trials for its monoclonal anti-IgE antibody ligelizumab (QGE031) 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.
Charité-Universitätsmedizin Allergie-Centrum-Charité Department of Dermatology and Allergy Dermatology and Allergy Professor and Research Director Marcus Maurer said: “CSU has a big impact on patients’ lives.
“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 immunology, hepatology and dermatology global development unit head Eric Hughes said: “Novartis is committed to leveraging our strong heritage and expertise in immuno-dermatology to reimagine and discover potential new treatments which can benefit patients.
“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.
Source: Company Press Release