Study of ICP-332 Tablets for Treating Moderate to Severe Chronic Spontaneous Urticaria in Adults Not Controlled by Second Generation H1-antihistamines Phase 23 Randomized, Double-blind, Placebo-controlled Trial

What this Trial Is About

Researchers are evaluating the efficacy and safety of ICP-332 in adults with moderate to severe chronic spontaneous urticaria CSU who have not responded well to second generation H1-antihistamines. This study is a Phase IIIII randomized, double-blind, placebo-controlled trial conducted by Beijing InnoCare Pharma Tech Co., Ltd. It aims to understand how well ICP-332 works and how safe it is for this patient group. Participants will receive ICP-332 tablets or a placebo tablet. In Phase 2, there are three different doses of ICP-332 being tested against placebo, with treatment lasting 4 weeks. In Phase 3, participants receive one of the doses or placebo for 12 weeks. Some participants may receive ICP-332 tablets for up to 24 weeks as well. All treatments are given as tablets. During the study, participants will be monitored regularly with assessments focusing on changes in their Weekly Urticaria Activity Score UAS7 at 4 weeks for Phase 2 and 12 weeks for Phase 3. Researchers will collect data on symptoms, safety, and overall health. The trial runs until September 2028, with participants involved for the full treatment period and follow-up evaluations to track effectiveness and safety.

Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria