NCT07378527

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

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of ICP-332 in Moderate to Severe Chronic Spontaneous Urticaria Subjects Inadequately Controlled by Second Generation H1-antihistamines

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 344 (estimated)
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of ICP-332 in moderate to severe chronic spontaneous urticaria subjects inadequately controlled by second generation H1-antihistamines

Conditions

• Chronic Spontaneous Urticaria (CSU)

Interventions

Type	Name	Description
DRUG	ICP-332 Tablets	ICP-332 will be administered as tablet for 12 weeks
DRUG	ICP-332 placebo Tablets	ICP-332 placebo will be administered as tablet for 12 weeks
DRUG	ICP-332 Tablets	ICP-332 will be administered as tablet for 24 weeks

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2026-01-30
• Last updated: 2026-01-30

Locations

30 sites across 1 country: China