Last updated on June 2019

A Phase III Study of Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.

Brief description of study

The purpose of this study is to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab.

The study population will consist of approximately 1050 male and female subjects aged 12 years who have been diagnosed with CSU and who remain symptomatic despite the use of H1-antihistamines. Of these, approximately 1000 adults and 50 adolescents are planned for inclusion in the study.

This is a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There is a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.

Clinical Study Identifier: NCT03580356

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Novartis Investigative Site

Mannheim, Germany
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