Last updated on June 2019

A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately Controlled With H1- Antihistamines


Brief description of study

The purpose of this study is to evaluate the safety and efficacy of ligelizumab in adult Japanese subjects with CSU, who remain symptomatic despite treatment with H1-antihistamines (AHs) at locally approved doses.

The study population will consist of approximately 65 male and female subjects aged 18 years who have been diagnosed with CSU and who remain symptomatic despite the use of H1-AH.

This is a Phase III multi-center, open-label, single arm study. There is a screening period of up to 28 days, a 52 week treatment period, and a 12 week post-treatment follow-up period.

Clinical Study Identifier: NCT03907878

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Novartis Investigative Site

Itabashi-ku, Japan
2.35miles
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