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Clinical Trial NCT07047612 for Non Segmental Vitiligo is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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ICP-332 in Subjects With Non-segmental Vitiligo Phase 2, Phase 3 603 Randomized Double-Blind Placebo-Controlled Adaptive Design
Clinical Trial NCT07047612 is designed to study Treatment for Non Segmental Vitiligo. It is a Phase 2 Phase 3 interventional study that is recruiting, having started on May 9, 2025, with plans to enroll 603 participants. Led by Beijing InnoCare Pharma Tech Co., Ltd., it is expected to complete by April 1, 2029. The latest data from ClinicalTrials.gov was last updated on August 7, 2025.
Brief 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.
Official Title
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
Conditions
Non Segmental VitiligoOther Study IDs
- ICP-CL-00607
NCT ID Number
Start Date (Actual)
2025-05-09
Last Update Posted
2025-08-07
Completion Date (Estimated)
2029-04
Enrollment (Estimated)
603
Study Type
Interventional
PHASE
Phase 2
Phase 3
Phase 3
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalICP-332 dose A（Phase2） | ICP-332 Tablets ICP-332 will be administered as tablet |
Placebo ComparatorPlacebo（Phase2） | ICP-332 Placebo Tablets ICP-332 Placebo will be administered as tablet |
ExperimentalICP-332 dose B（Phase2:） | ICP-332 Tablets ICP-332 will be administered as tablet |
ExperimentalICP-332 dose A or dose B（Phase3） | ICP-332 Tablets ICP-332 will be administered as tablet |
Placebo ComparatorPlacebo（Phase3） | ICP-332 Placebo Tablets ICP-332 Placebo will be administered as tablet |
Primary Outcome Measures
| Outcome Measure | 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Minimum Age
12 Years
Eligible Sexes
All
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.
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.
Beijing InnoCare Pharma Tech Co., Ltd.Study Central Contact
Contact: Flora Xiang, Doctor, 021-52887775, [email protected]
45 Study Locations in 1 Countries
Anhui
The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, 241001, China
Chao Ci, Contact
Not yet recruiting
The Second Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China
Ruzhi Zhang, Contact
Not yet recruiting
Beijing Municipality
Peking University Third Hospital, Beijing, Beijing Municipality, 100191, China
Chunlei Zhang, Contact
Not yet recruiting
Beijing Chao-yang Hospital,Capital Medical University, Beijing, Beijing Municipality, China
Fang Liu, Contact
Not yet recruiting
Beijing Tongren Hospital, Beijing, Beijing Municipality, China
Aihua Wei, Contact
Not yet recruiting
Chongqing Municipality
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, 400016, China
Bin Wei, Contact
Not yet recruiting
Chongqing Traditional Chinese Medicine Hospital, Chongqing, Chongqing Municipality, 400021, China
Qingchun 400000 Diao, Contact
Recruiting
Fujian
Union Hospital affiliated to Fujian Medical, Fuzhou, Fujian, 350001, China
Huichun Su, Contact
Not yet recruiting
The First Affiliated Hospital of Fujian Medical, Fuzhou, Fujian, 350005, China
Niu Xiang, Contact
Not yet recruiting
Guangdong
Sun Yat-sen Memorial Hospital,Sun Yat-sen University, Guangzhou, Guangdong, 510120, China
Liangchun Wang, Contact
Not yet recruiting
Deramatology Hospital of Southern Medical Univercity, Guangzhou, Guangdong, 516006, China
Xiaowei Shi, Contact
Not yet recruiting
Nanfang Hospital, Guangzhou, Guangdong, China
Yue Zheng, Contact
Not yet recruiting
Hebei
The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050051, China
Yanling Li, Contact
Not yet recruiting
Henan
The Second Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, China
Bin Zhang, Contact
Not yet recruiting
Nanyang First People's Hospital, Nanyang, Henan, 473000, China
Rixin Chen, Contact
Not yet recruiting
The First Affiliated Hospital of Xinxiang Medical College, Weihui, Henan, 453100, China
Dandan Fu, Contact
Not yet recruiting
Henan Provincial People's Hospital, Zhengzhou, Henan, China
Jianguo Li, Contact
Not yet recruiting
Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou, Henan, China
Zixue Chen, Contact
Not yet recruiting
Hubei
Jingzhou Central Hospital, Jingzhou, Hubei, 434020, China
Yi Sun, Contact
Not yet recruiting
Shiyan People's Hospital, Shiyan, Hubei, China
Zudong Meng, Contact
Not yet recruiting
Wuhan NO.1 Hospital(Wuhan Hospital of Traditional Chinese and Western Medicine), Wuhan, Hubei, 430022, China
Liuqing Chen, Contact
Not yet recruiting
Hunan
Xiangya Hospital of Central South University, Changsha, Hunan, 410008, China
Juan Li, Contact
Not yet recruiting
The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China
Yunsheng Liang, Contact
Not yet recruiting
The First Affiliated Hospital of University Of South China, Hengyang, Hunan, China
Zhijun Liu, Contact
Not yet recruiting
Jiangsu
The First People's Hospital of Lianyungang, Lianyungang, Jiangsu, 222061, China
Hong Ren, Contact
Not yet recruiting
Hospital for Skin Diseases, Chinese Academy of Medical Sciences, Nanjing, Jiangsu, 210042, China
Qianjin Lu, Contact
Not yet recruiting
Suzhou Municipal Hospital, Suzhou, Jiangsu, 215002, China
Jun Gu, Contact
Not yet recruiting
Jiangxi
Dermatology hospital of jiangxi province, Nanchang, Jiangxi, 330000, China
Xiaoyi Wen, Contact
Not yet recruiting
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, China
Xianwei Cao, Contact
Not yet recruiting
Jilin
The first hospital of Jilin Univercity, Changchun, Jilin, 130021, China
Shanshan Li, Contact
Not yet recruiting
Liaoning
Shenyang Medical College Affiliated Central Hospital, Shenyang, Liaoning, China
Xiaodong Li, Contact
Not yet recruiting
Shandong
Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China
Yin Li, Contact
Recruiting
Shandong First Medical University Affiliated Dermatology Hospital (Shandong Institute of Dermatology and Venereology, Shandong Dermatology Hospital), Jinan, Shandong, 250022, China
Furen Zhang, Contact
Not yet recruiting
Zibo Central Hospital, Zibo, Shandong, China
Guowei Zhao, Contact
Not yet recruiting
Shanghai Municipality
Huashan Hospital Fudan University, Shanghai, Shanghai Municipality, 200040, China
Folra Xiang, Contact
Recruiting
Shanghai Dermatology Hospital, Shanghai, Shanghai Municipality, 200050, China
Yangfeng Ding, Contact
Not yet recruiting
Shanxi
Shaanxi Provincial People's Hospital, Xian, Shanxi, 710068, China
Li Yang, Contact
Not yet recruiting
Sichuan
Chengdu Second People's Hospital, Chengdu, Sichuan, 610021, China
Yanping Feng, Contact
Not yet recruiting
Sichuan Provincial People's Hospital, Chengdu, Sichuan, 610072, China
Lixia Zhang, Contact
Not yet recruiting
Yunnan
The First Affiliated Hospital Of Kunming Medical University, Kunming, Yunnan, 650032, China
Dongjie Sun, Contact
Not yet recruiting
Zhejiang
Hangzhou Third People's Hospital, Hangzhou, Zhejiang, 310009, China
Aie Xu, Contact
Recruiting
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, China
Liming Wu, Contact
Not yet recruiting
The First Affiliated Hospital Of Ningbo University, Ningbo, Zhejiang, 315100, China
Bingjiang Lin, Contact
Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China
Zhiming Li, Contact
Not yet recruiting
The Fourth Affiliated Hospital, Zhejiang University School Of Medicine, Yiwu, Zhejiang, 322000, China
Lunfei Liu, Contact
Not yet recruiting