Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-332 dose A（Phase2） | Experimental | ICP-332 will be administered as tablet |
|
| ICP-332 dose B（Phase2） | Experimental | ICP-332 will be administered as tablet |
|
| ICP-332 dose C（Phase2） | Experimental | ICP-332 will be administered as tablet |
|
| Placebo（Phase2） | Placebo Comparator | ICP-332 Placebo will be administered as tablet |
|
| ICP-332 dose A or dose B or dose C（Phase3） | Experimental | ICP-332 will be administered as tablet |
|
| Placebo（Phase3） | Placebo Comparator | ICP-332 Placebo will be administered as tablet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-332 Tablets | Drug | ICP-332 will be administered as tablet for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianzhong Zhang | Contact | +86-010-88325474 | rmzjz@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bengbu Medical University First Affiliated Hospital | Not yet recruiting | Bengbu | Anhui | 233004 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| ICP-332 placebo Tablets | Drug | ICP-332 placebo will be administered as tablet for 12 weeks |
|
| ICP-332 Tablets | Drug | ICP-332 will be administered as tablet for 24 weeks |
|
| The Second Affiliated Hospital of Wannan Medical College | Not yet recruiting | Wuhu | Anhui | 241000 | China |
|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
|
| Beijing Tongren Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100730 | China |
|
| The First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | 400016 | China |
|
| Chongqing Traditional Chinese Medicine Hospital | Not yet recruiting | Chongqing | Chongqing Municipality | 400021 | China |
|
| First Affiliated Hospital of Fujian Medical University | Not yet recruiting | Fuzhou | Fujian | 350005 | China |
|
| Dermatology Hospital of Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | 510091 | China |
|
| The Second Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | 050000 | China |
|
| The Second Affiliated Hospital of Henan University of Science and Technology | Not yet recruiting | Luoyang | Henan | China |
|
| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
|
| Jingzhou Central Hospital | Not yet recruiting | Jingzhou | Hubei | 434020 | China |
|
| Shiyan Taihe Hospital | Not yet recruiting | Shiyan | Hubei | 442000 | China |
|
| Xiangya hospital central south university | Not yet recruiting | Changsha | Hunan | 410008 | China |
|
| Suzhou Municipal Hospital | Not yet recruiting | Suzhou | Jiangsu | 215002 | China |
|
| Wuxi No. 2 People's Hospital | Not yet recruiting | Wuxi | Jiangsu | 214001 | China |
|
| Affiliated Hospital of Jiangsu University | Not yet recruiting | Zhenjiang | Jiangsu | 210031 | China |
|
| The First Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130021 | China |
|
| Shenyang Hospital of Integrated Traditional Chinese and Western Medicine （Shenyang Seventh People's Hospital） | Not yet recruiting | Shenyang | Liaoning | 110001 | China |
|
| The First Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | 710061 | China |
|
| Jinan Central Hospital | Not yet recruiting | Jinan | Shandong | 250013 | China |
|
| Shandong Provincial Hospital for Skin Disease, Shandong First Medical University | Not yet recruiting | Jinan | Shandong | 250022 | China |
|
| Shanghai Skin Disease Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200443 | China |
|
| First Hospital of Shanxi Medical University | Not yet recruiting | Taiyuan | Shanxi | 030001 | China |
|
| Chengdu Second People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610017 | China |
|
| Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610072 | China |
|
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300131 | China |
|
| The First Affiliated Hospital of Kunming Medical University | Not yet recruiting | Kunming | Yunnan | 650032 | China |
|
| Hangzhou Third People's Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310009 | China |
|
| Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University | Not yet recruiting | Hangzhou | Zhejiang | China |
|
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided