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This a phase II/III randomized, double-blind, placebo-controlled, parallel group, adaptive design, multi-center study to evaluate the efficacy and safety of ICP-332 in subjects with non-segmental vitiligo。The study consisted an phase 2 part and an phase 3 part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-332 dose A(Phase2) | Experimental |
| |
| Placebo(Phase2) | Placebo Comparator |
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| ICP-332 dose B(Phase2:) | Experimental |
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| ICP-332 dose A or dose B(Phase3) | Experimental |
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| Placebo(Phase3) | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-332 Tablets | Drug | ICP-332 will be administered as tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase2: Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24. | 24 weeks | |
| Phase3: Proportion of subjects achieving F-VASI 75 at Week 52. | 52 weeks |
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Inclusion Criteria:
Male or female subjects aged ≥18 years and ≤75 years (Phase II portion). Male or female subjects ≥12 years of age and ≤75 years of age, adolescent subjects must weigh ≥40 kg (Phase III portion).
Eligible subjects must meet all of the following criteria at screening and baseline:
Women of childbearing potential (WOCBP) and Men must agree to contraception.
Before beginning any screening or study specific procedures, subjects must voluntarily sign informed consent.
Exclusion Criteria:
Any of the following vitiligo related medical conditions and other skin diseases/conditions.
a) Subjects had other types of vitiligo (including but not limited to segmental vitiligo and mixed vitiligo) that did not meet the criteria for active or stable vitiligo described in Inclusion criteria 2.
History of any clinically major diseases, with the exception of vitiligo.
Pregnant or breastfeeding females.
The investigator considers that the subject is not suitable for participation in this study for any reason.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Flora Xiang, Doctor | Contact | 021-52887775 | flora_xiang@vip.163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Wannan Medical College | Not yet recruiting | Wuhu | Anhui | 241001 | China |
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| ICP-332 Placebo Tablets | Drug | ICP-332 Placebo will be administered as tablet |
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| The Second Affiliated Hospital of Wannan Medical College | Not yet recruiting | Wuhu | Anhui | China |
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| Peking University Third Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100191 | China |
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| Beijing Chao-yang Hospital,Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Beijing Tongren Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| The First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | 400016 | China |
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| Chongqing Traditional Chinese Medicine Hospital | Recruiting | Chongqing | Chongqing Municipality | 400021 | China |
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| Union Hospital affiliated to Fujian Medical | Not yet recruiting | Fuzhou | Fujian | 350001 | China |
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| The First Affiliated Hospital of Fujian Medical | Not yet recruiting | Fuzhou | Fujian | 350005 | China |
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| Sun Yat-sen Memorial Hospital,Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | 510120 | China |
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| Deramatology Hospital of Southern Medical Univercity | Not yet recruiting | Guangzhou | Guangdong | 516006 | China |
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| Nanfang Hospital | Not yet recruiting | Guangzhou | Guangdong | China |
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| The Second Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | 050051 | China |
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| The Second Affiliated Hospital of Henan University of Science and Technology | Not yet recruiting | Luoyang | Henan | China |
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| Nanyang First People's Hospital | Not yet recruiting | Nanyang | Henan | 473000 | China |
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| The First Affiliated Hospital of Xinxiang Medical College | Not yet recruiting | Weihui | Henan | 453100 | China |
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| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | China |
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| Zhengzhou Central Hospital Affiliated to Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | China |
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| Jingzhou Central Hospital | Not yet recruiting | Jingzhou | Hubei | 434020 | China |
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| Shiyan People's Hospital | Not yet recruiting | Shiyan | Hubei | China |
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| Wuhan NO.1 Hospital(Wuhan Hospital of Traditional Chinese and Western Medicine) | Not yet recruiting | Wuhan | Hubei | 430022 | China |
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| Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410008 | China |
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| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410011 | China |
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| The First Affiliated Hospital of University Of South China | Not yet recruiting | Hengyang | Hunan | China |
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| The First People's Hospital of Lianyungang | Not yet recruiting | Lianyungang | Jiangsu | 222061 | China |
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| Hospital for Skin Diseases, Chinese Academy of Medical Sciences | Not yet recruiting | Nanjing | Jiangsu | 210042 | China |
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| Suzhou Municipal Hospital | Not yet recruiting | Suzhou | Jiangsu | 215002 | China |
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| Dermatology hospital of jiangxi province | Not yet recruiting | Nanchang | Jiangxi | 330000 | China |
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| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
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| The first hospital of Jilin Univercity | Not yet recruiting | Changchun | Jilin | 130021 | China |
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| Shenyang Medical College Affiliated Central Hospital | Not yet recruiting | Shenyang | Liaoning | China |
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| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| Shandong First Medical University Affiliated Dermatology Hospital (Shandong Institute of Dermatology and Venereology, Shandong Dermatology Hospital) | Not yet recruiting | Jinan | Shandong | 250022 | China |
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| Zibo Central Hospital | Not yet recruiting | Zibo | Shandong | China |
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| Huashan Hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| Shanghai Dermatology Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200050 | China |
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| Shaanxi Provincial People's Hospital | Not yet recruiting | Xian | Shanxi | 710068 | China |
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| Chengdu Second People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610021 | China |
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| Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610072 | China |
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| The First Affiliated Hospital Of Kunming Medical University | Not yet recruiting | Kunming | Yunnan | 650032 | China |
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| Hangzhou Third People's Hospital | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University | Not yet recruiting | Hangzhou | Zhejiang | China |
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| The First Affiliated Hospital Of Ningbo University | Not yet recruiting | Ningbo | Zhejiang | 315100 | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | Zhejiang | 325000 | China |
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| The Fourth Affiliated Hospital, Zhejiang University School Of Medicine | Not yet recruiting | Yiwu | Zhejiang | 322000 | China |
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