A Phase 2/3 interventional study of ICP-332 Tablets and ICP-332 placebo Tablets in Chronic Spontaneous Urticaria (CSU), sponsored by Beijing InnoCare Pharma Tech Co., Ltd.. Recruiting at 30 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Beijing InnoCare Pharma Tech Co., Ltd. · Phase 2/3, Interventional, and Treatment
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
214 studies on the registry are indexed under Chronic Urticaria; 47 are open to participants now.
This study's planned enrollment of 344 is above the median of 83 across 164 interventional studies indexed under Chronic Urticaria.
Browse Chronic Urticaria studies →Beijing InnoCare Pharma Tech Co., Ltd. is the lead sponsor of 57 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
ICP-332 will be administered as tablet
Drug: ICP-332 Tablets
ICP-332 will be administered as tablet
Drug: ICP-332 Tablets
ICP-332 will be administered as tablet
Drug: ICP-332 Tablets
ICP-332 Placebo will be administered as tablet
Drug: ICP-332 placebo Tablets
ICP-332 will be administered as tablet
Drug: ICP-332 Tablets
ICP-332 Placebo will be administered as tablet
Drug: ICP-332 placebo Tablets
ICP-332 will be administered as tablet for 12 weeks
ICP-332 placebo will be administered as tablet for 12 weeks
ICP-332 will be administered as tablet for 24 weeks
Phase 2: Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4.
The Weekly Urticaria Activity Score (UAS7) is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42 (highest urticaria severity), and a minimum possible score of 0.
Time frame: 4 weeks
Phase 3: Change from baseline in UAS7 at Week 12.
The Weekly Urticaria Activity Score (UAS7) is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The possible range of the UAS7 score is 0 - 42 (highest hives and itch severity).
Time frame: 12 weeks
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Beijing InnoCare Pharma Tech Co., Ltd.