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: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 1\. Men and women aged 18 to 75 years.
• 2\. Diagnosis of CSU inadequately controlled by second generation H1-antihistamines.
• 3\. CSU duration for ≥ 6 months prior to randomization.
• 4\. Before initiating any screening or study-specific procedures, the subject must voluntarily sign the informed consent form.
Locations
Other Locations
China
Beijing Tongren Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
Bengbu Medical University First Affiliated Hospital
NOT_YET_RECRUITING
Bengbu
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Xiangya hospital central south university
NOT_YET_RECRUITING
Changsha
Chengdu Second People's Hospital
NOT_YET_RECRUITING
Chengdu
Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
Chongqing Traditional Chinese Medicine Hospital
NOT_YET_RECRUITING
Chongqing
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
First Affiliated Hospital of Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
Dermatology Hospital of Southern Medical University
NOT_YET_RECRUITING
Guangzhou
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
NOT_YET_RECRUITING
Hangzhou
Hangzhou Third People's Hospital
NOT_YET_RECRUITING
Hangzhou
Jinan Central Hospital
NOT_YET_RECRUITING
Jinan
Shandong Provincial Hospital for Skin Disease, Shandong First Medical University
NOT_YET_RECRUITING
Jinan
Jingzhou Central Hospital
NOT_YET_RECRUITING
Jingzhou
The First Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITING
Kunming
The Second Affiliated Hospital of Henan University of Science and Technology
NOT_YET_RECRUITING
Luoyang
Shanghai Skin Disease Hospital
NOT_YET_RECRUITING
Shanghai
Shenyang Hospital of Integrated Traditional Chinese and Western Medicine （Shenyang Seventh People's Hospital）
NOT_YET_RECRUITING
Shenyang
The Second Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Shiyan Taihe Hospital
NOT_YET_RECRUITING
Shiyan
Suzhou Municipal Hospital
NOT_YET_RECRUITING
Suzhou
First Hospital of Shanxi Medical University
NOT_YET_RECRUITING
Taiyuan
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
NOT_YET_RECRUITING
Tianjin
The Second Affiliated Hospital of Wannan Medical College
NOT_YET_RECRUITING
Wuhu
Wuxi No. 2 People's Hospital
NOT_YET_RECRUITING
Wuxi
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
Henan Provincial People's Hospital
NOT_YET_RECRUITING
Zhengzhou
Affiliated Hospital of Jiangsu University
NOT_YET_RECRUITING
Zhenjiang
Contact Information
Primary
Jianzhong Zhang
rmzjz@126.com
+86-010-88325474
Time Frame
Start Date: 2026-02-13
Estimated Completion Date: 2028-09
Participants
Target number of participants: 344
Treatments
Experimental: ICP-332 dose A（Phase2）
ICP-332 will be administered as tablet
Experimental: ICP-332 dose B（Phase2）
ICP-332 will be administered as tablet
Experimental: ICP-332 dose C（Phase2）
ICP-332 will be administered as tablet
Placebo_comparator: Placebo（Phase2）
ICP-332 Placebo will be administered as tablet
Experimental: ICP-332 dose A or dose B or dose C（Phase3）
ICP-332 will be administered as tablet
Placebo_comparator: Placebo（Phase3）
ICP-332 Placebo will be administered as tablet
Related Therapeutic Areas
Sponsors
Leads: Beijing InnoCare Pharma Tech Co., Ltd.