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Clinical Trials in China / NCT07047612
Recruiting Phase 2/3

ICP-332 in Subjects With Non-segmental Vitiligo

NCT07047612 · tracked via the Priya Life Science China tracker
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Phase
Phase 2/3
Started
2025-05-09
Last updated
2025-08-07

Condition(s) studied

Non Segmental Vitiligo

Investigational drug(s) / intervention(s)

ICP-332 Tablets →ICP-332 Placebo Tablets

ICP-332 Tablets: ICP-332 will be administered as tablet

ICP-332 Placebo Tablets: ICP-332 Placebo will be administered as tablet

Study 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

Sex
ALL
Min age
12 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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). 2. Eligible subjects must meet all of the following criteria at screening and baseline: 1. The clinical diagnosis was non-segmental vitiligo for at least 3 months. 2. Involvement of BSA≥5%. 3. Facial involvement BSA≥0.5%. 4. F-VASI≥0.5 and T-VASI between 5 and 50. 5. Active or stable non-segmental vitiligo was present at both screening and baseline visits. 3. Women of childbearing potential (WOCBP) and Men must agree to contraception. 4. Before beginning any screening or study specific procedures, subjects must voluntarily sign informed consent. Exclusion Criteria: 1. 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. 2. History of any clinically major diseases, with the exception of vitiligo. 3. Pregnant or breastfeeding females. 4. The investigator considers that the subject is not suitable for participation in this study for any reason.

Primary outcome measure(s)

Trial sites (45)

FacilityCityRegionStatus
The First Affiliated Hospital of Wannan Medical College Wuhu Anhui Not Yet Recruiting
The Second Affiliated Hospital of Wannan Medical College Wuhu Anhui Not Yet Recruiting
Peking University Third Hospital Beijing Beijing Municipality Not Yet Recruiting
Beijing Chao-yang Hospital,Capital Medical University Beijing Beijing Municipality Not Yet Recruiting
Beijing Tongren Hospital Beijing Beijing Municipality Not Yet Recruiting
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Not Yet Recruiting
Chongqing Traditional Chinese Medicine Hospital Chongqing Chongqing Municipality Recruiting
Union Hospital affiliated to Fujian Medical Fuzhou Fujian Not Yet Recruiting
The First Affiliated Hospital of Fujian Medical Fuzhou Fujian Not Yet Recruiting
Sun Yat-sen Memorial Hospital,Sun Yat-sen University Guangzhou Guangdong Not Yet Recruiting
Deramatology Hospital of Southern Medical Univercity Guangzhou Guangdong Not Yet Recruiting
Nanfang Hospital Guangzhou Guangdong Not Yet Recruiting
The Second Hospital of Hebei Medical University Shijiazhuang Hebei Not Yet Recruiting
The Second Affiliated Hospital of Henan University of Science and Technology Luoyang Henan Not Yet Recruiting
Nanyang First People's Hospital Nanyang Henan Not Yet Recruiting
The First Affiliated Hospital of Xinxiang Medical College Weihui Henan Not Yet Recruiting
Henan Provincial People's Hospital Zhengzhou Henan Not Yet Recruiting
Zhengzhou Central Hospital Affiliated to Zhengzhou University Zhengzhou Henan Not Yet Recruiting
Jingzhou Central Hospital Jingzhou Hubei Not Yet Recruiting
Shiyan People's Hospital Shiyan Hubei Not Yet Recruiting
Wuhan NO.1 Hospital(Wuhan Hospital of Traditional Chinese and Western Medicine) Wuhan Hubei Not Yet Recruiting
Xiangya Hospital of Central South University Changsha Hunan Not Yet Recruiting
The Second Xiangya Hospital of Central South University Changsha Hunan Not Yet Recruiting
The First Affiliated Hospital of University Of South China Hengyang Hunan Not Yet Recruiting
The First People's Hospital of Lianyungang Lianyungang Jiangsu Not Yet Recruiting
Hospital for Skin Diseases, Chinese Academy of Medical Sciences Nanjing Jiangsu Not Yet Recruiting
Suzhou Municipal Hospital Suzhou Jiangsu Not Yet Recruiting
Dermatology hospital of jiangxi province Nanchang Jiangxi Not Yet Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Not Yet Recruiting
The first hospital of Jilin Univercity Changchun Jilin Not Yet Recruiting
Shenyang Medical College Affiliated Central Hospital Shenyang Liaoning Not Yet Recruiting
Qilu Hospital of Shandong University Jinan Shandong Recruiting
Shandong First Medical University Affiliated Dermatology Hospital (Shandong Institute of Dermatology and Venereology, Shandong Dermatology Hospital) Jinan Shandong Not Yet Recruiting
Zibo Central Hospital Zibo Shandong Not Yet Recruiting
Huashan Hospital Fudan University Shanghai Shanghai Municipality Recruiting
Shanghai Dermatology Hospital Shanghai Shanghai Municipality Not Yet Recruiting
Shaanxi Provincial People's Hospital Xian Shanxi Not Yet Recruiting
Chengdu Second People's Hospital Chengdu Sichuan Not Yet Recruiting
Sichuan Provincial People's Hospital Chengdu Sichuan Not Yet Recruiting
The First Affiliated Hospital Of Kunming Medical University Kunming Yunnan Not Yet Recruiting

+ 5 more sites — see the full list on the official registry below.

More Beijing InnoCare Pharma Tech Co., Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07047612 on ClinicalTrials.gov ↗ ← All trials in China