A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
The purpose of this study was to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.
The study population consisted of 1,079 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines.
This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.
This was a Phase III multi-center, randomized, double-blind, active and placebo-controlled, parallel-group study. The study consisted of 3 distinct periods:
Key Inclusion Criteria:
Key Exclusion Criteria:
Scottsdale, Arizona 85251, United States
CABA, Buenos Aires C1181ACH, Argentina
CABA, Buenos Aires C1414AIF, Argentina
CABA, 1035, Argentina
Alphaville Barueri, São Paulo 06454010, Brazil
Halle S, 06120, Germany
Kamimashi-gun, Kumamoto 861-3106, Japan
Itabashi-ku, Tokyo 173-8610, Japan
Setagaya-ku, Tokyo 158-0097, Japan
Shinagawa Ku, Tokyo 141 8625, Japan
Amersfroort, 3818 ES, Netherlands