ICP-332 in Subjects With Non-segmental Vitiligo
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
1 other identifier
interventional
603
1 country
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2025
Typical duration for phase_2
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 9, 2025
CompletedFirst Submitted
Initial submission to the registry
June 23, 2025
CompletedFirst Posted
Study publicly available on registry
July 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
August 7, 2025
April 1, 2025
3.9 years
June 23, 2025
August 5, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (5)
ICP-332 dose A（Phase2）
EXPERIMENTALPlacebo（Phase2）
PLACEBO COMPARATORICP-332 dose B（Phase2:）
EXPERIMENTALICP-332 dose A or dose B（Phase3）
EXPERIMENTALPlacebo（Phase3）
PLACEBO COMPARATORInterventions
ICP-332 will be administered as tablet
ICP-332 Placebo will be administered as tablet
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any of the following vitiligo related medical conditions and other skin diseases/conditions.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001, China
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Beijing Chao-yang Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, 400021, China
Union Hospital affiliated to Fujian Medical
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital of Fujian Medical
Fuzhou, Fujian, 350005, China
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
Deramatology Hospital of Southern Medical Univercity
Guangzhou, Guangdong, 516006, China
Nanfang Hospital
Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051, China
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Nanyang First People's Hospital
Nanyang, Henan, 473000, China
The First Affiliated Hospital of Xinxiang Medical College
Weihui, Henan, 453100, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Zhengzhou, Henan, China
Jingzhou Central Hospital
Jingzhou, Hubei, 434020, China
Shiyan People's Hospital
Shiyan, Hubei, China
Wuhan NO.1 Hospital(Wuhan Hospital of Traditional Chinese and Western Medicine)
Wuhan, Hubei, 430022, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The First Affiliated Hospital of University Of South China
Hengyang, Hunan, China
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222061, China
Hospital for Skin Diseases, Chinese Academy of Medical Sciences
Nanjing, Jiangsu, 210042, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215002, China
Dermatology hospital of jiangxi province
Nanchang, Jiangxi, 330000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The first hospital of Jilin Univercity
Changchun, Jilin, 130021, China
Shenyang Medical College Affiliated Central Hospital
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Shandong First Medical University Affiliated Dermatology Hospital (Shandong Institute of Dermatology and Venereology, Shandong Dermatology Hospital)
Jinan, Shandong, 250022, China
Zibo Central Hospital
Zibo, Shandong, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, 200050, China
Shaanxi Provincial People's Hospital
Xian, Shanxi, 710068, China
Chengdu Second People's Hospital
Chengdu, Sichuan, 610021, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
The First Affiliated Hospital Of Kunming Medical University
Kunming, Yunnan, 650032, China
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, 310009, China
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, China
The First Affiliated Hospital Of Ningbo University
Ningbo, Zhejiang, 315100, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
The Fourth Affiliated Hospital, Zhejiang University School Of Medicine
Yiwu, Zhejiang, 322000, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2025
First Posted
July 2, 2025
Study Start
May 9, 2025
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
August 7, 2025
Record last verified: 2025-04