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
Status: Recruiting
Location: See all (45) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 75
Healthy Volunteers: f
View:
• 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:
‣ The clinical diagnosis was non-segmental vitiligo for at least 3 months.
⁃ Involvement of BSA≥5%.
⁃ Facial involvement BSA≥0.5%.
⁃ F-VASI≥0.5 and T-VASI between 5 and 50.
⁃ Active or stable non-segmental vitiligo was present at both screening and baseline visits.
• 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.
Locations
Other Locations
China
Beijing Chao-yang Hospital,Capital Medical University
NOT_YET_RECRUITING
Beijing
Beijing Tongren Hospital
NOT_YET_RECRUITING
Beijing
Peking University Third Hospital
NOT_YET_RECRUITING
Beijing
The first hospital of Jilin Univercity
NOT_YET_RECRUITING
Changchun
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Chengdu Second People's Hospital
NOT_YET_RECRUITING
Chengdu
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
Chongqing Traditional Chinese Medicine Hospital
RECRUITING
Chongqing
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
The First Affiliated Hospital of Fujian Medical
NOT_YET_RECRUITING
Fuzhou
Union Hospital affiliated to Fujian Medical
NOT_YET_RECRUITING
Fuzhou
Deramatology Hospital of Southern Medical Univercity
NOT_YET_RECRUITING
Guangzhou
Nanfang Hospital
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen Memorial Hospital,Sun Yat-sen 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
RECRUITING
Hangzhou
The First Affiliated Hospital of University Of South China
NOT_YET_RECRUITING
Hengyang
Qilu Hospital of Shandong University
RECRUITING
Jinan
Shandong First Medical University Affiliated Dermatology Hospital (Shandong Institute of Dermatology and Venereology, Shandong Dermatology Hospital)
NOT_YET_RECRUITING
Jinan
Jingzhou Central Hospital
NOT_YET_RECRUITING
Jingzhou
The First Affiliated Hospital Of Kunming Medical University
NOT_YET_RECRUITING
Kunming
The First People's Hospital of Lianyungang
NOT_YET_RECRUITING
Lianyungang
The Second Affiliated Hospital of Henan University of Science and Technology
NOT_YET_RECRUITING
Luoyang
Dermatology hospital of jiangxi province
NOT_YET_RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Hospital for Skin Diseases, Chinese Academy of Medical Sciences
NOT_YET_RECRUITING
Nanjing
Nanyang First People's Hospital
NOT_YET_RECRUITING
Nanyang
The First Affiliated Hospital Of Ningbo University
NOT_YET_RECRUITING
Ningbo
Huashan Hospital Fudan University
RECRUITING
Shanghai
Shanghai Dermatology Hospital
NOT_YET_RECRUITING
Shanghai
Shenyang Medical College Affiliated Central Hospital
NOT_YET_RECRUITING
Shenyang
The Second Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Shiyan People's Hospital
NOT_YET_RECRUITING
Shiyan
Suzhou Municipal Hospital
NOT_YET_RECRUITING
Suzhou
The First Affiliated Hospital of Xinxiang Medical College
NOT_YET_RECRUITING
Weihui
The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Wuhan NO.1 Hospital(Wuhan Hospital of Traditional Chinese and Western Medicine)
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Wannan Medical College
NOT_YET_RECRUITING
Wuhu
The Second Affiliated Hospital of Wannan Medical College
NOT_YET_RECRUITING
Wuhu
Shaanxi Provincial People's Hospital
NOT_YET_RECRUITING
Xian
The Fourth Affiliated Hospital, Zhejiang University School Of Medicine
NOT_YET_RECRUITING
Yiwu
Henan Provincial People's Hospital
NOT_YET_RECRUITING
Zhengzhou
Zhengzhou Central Hospital Affiliated to Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Zibo Central Hospital
NOT_YET_RECRUITING
Zibo
Contact Information
Primary
Flora Xiang, Doctor
flora_xiang@vip.163.com
021-52887775
Time Frame
Start Date: 2025-05-09
Estimated Completion Date: 2029-04
Participants
Target number of participants: 603
Treatments
Experimental: ICP-332 dose A（Phase2）
Placebo_comparator: Placebo（Phase2）
Experimental: ICP-332 dose B（Phase2:）
Experimental: ICP-332 dose A or dose B（Phase3）
Placebo_comparator: Placebo（Phase3）
Related Therapeutic Areas
Sponsors
Leads: Beijing InnoCare Pharma Tech Co., Ltd.