ICP-332 in Subjects With Non-segmental Vitiligo

Last updated: August 5, 2025
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Vitiligo

Treatment

ICP-332 Placebo Tablets

ICP-332 Tablets

Clinical Study ID

NCT07047612
ICP-CL-00607
  • Ages 12-75
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subjects aged ≥18 years and ≤75 years (Phase II portion). Male orfemale subjects ≥12 years of age and ≤75 years of age, adolescent subjects mustweigh ≥40 kg (Phase III portion).

  2. Eligible subjects must meet all of the following criteria at screening and baseline:

  3. The clinical diagnosis was non-segmental vitiligo for at least 3 months.

  4. Involvement of BSA≥5%.

  5. Facial involvement BSA≥0.5%.

  6. F-VASI≥0.5 and T-VASI between 5 and 50.

  7. Active or stable non-segmental vitiligo was present at both screening andbaseline visits.

  8. Women of childbearing potential (WOCBP) and Men must agree to contraception.

  9. Before beginning any screening or study specific procedures, subjects mustvoluntarily sign informed consent.

Exclusion

Exclusion Criteria:

  1. Any of the following vitiligo related medical conditions and other skindiseases/conditions. a) Subjects had other types of vitiligo (including but not limited to segmentalvitiligo and mixed vitiligo) that did not meet the criteria for active or stablevitiligo 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 inthis study for any reason.

Study Design

Total Participants: 603
Treatment Group(s): 2
Primary Treatment: ICP-332 Placebo Tablets
Phase: 2/3
Study Start date:
May 09, 2025
Estimated Completion Date:
April 30, 2029

Connect with a study center

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui 241001
    China

    Site Not Available

  • The Second Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui
    China

    Site Not Available

  • Beijing Chao-yang Hospital,Capital Medical University

    Beijing, Beijing
    China

    Site Not Available

  • Beijing Tongren Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • Chongqing Traditional Chinese Medicine Hospital

    Chongqing, Chongqing 400021
    China

    Active - Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400016
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical

    Fuzhou, Fujian 350005
    China

    Site Not Available

  • Union Hospital affiliated to Fujian Medical

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Deramatology Hospital of Southern Medical Univercity

    Guangzhou, Guangdong 516006
    China

    Site Not Available

  • Nanfang Hospital

    Guangzhou, Guangdong
    China

    Site Not Available

  • Sun Yat-sen Memorial Hospital,Sun Yat-sen University

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050051
    China

    Site Not Available

  • The Second Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan
    China

    Site Not Available

  • Nanyang First People's Hospital

    Nanyang, Henan 473000
    China

    Site Not Available

  • The First Affiliated Hospital of Xinxiang Medical College

    Weihui, Henan 453100
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Zhengzhou Central Hospital Affiliated to Zhengzhou University

    Zhengzhou, Henan
    China

    Site Not Available

  • Jingzhou Central Hospital

    Jingzhou, Hubei 434020
    China

    Site Not Available

  • Shiyan People's Hospital

    Shiyan, Hubei
    China

    Site Not Available

  • Wuhan NO.1 Hospital(Wuhan Hospital of Traditional Chinese and Western Medicine)

    Wuhan, Hubei 430022
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Site Not Available

  • Xiangya Hospital of Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • The First Affiliated Hospital of University Of South China

    Hengyang, Hunan
    China

    Site Not Available

  • The First People's Hospital of Lianyungang

    Lianyungang, Jiangsu 222061
    China

    Site Not Available

  • Hospital for Skin Diseases, Chinese Academy of Medical Sciences

    Nanjing, Jiangsu 210042
    China

    Site Not Available

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu 215002
    China

    Site Not Available

  • Dermatology hospital of jiangxi province

    Nanchang, Jiangxi 330000
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The first hospital of Jilin Univercity

    Changchun, Jilin 130021
    China

    Site Not Available

  • Shenyang Medical College Affiliated Central Hospital

    Shenyang, Liaoning
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Active - Recruiting

  • Shandong First Medical University Affiliated Dermatology Hospital (Shandong Institute of Dermatology and Venereology, Shandong Dermatology Hospital)

    Jinan, Shandong 250022
    China

    Site Not Available

  • Zibo Central Hospital

    Zibo, Shandong
    China

    Site Not Available

  • Huashan Hospital Fudan University

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

  • Shanghai Dermatology Hospital

    Shanghai, Shanghai 200050
    China

    Site Not Available

  • Shaanxi Provincial People's Hospital

    Xian, Shanxi 710068
    China

    Site Not Available

  • Chengdu Second People's Hospital

    Chengdu, Sichuan 610021
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan 610072
    China

    Site Not Available

  • The First Affiliated Hospital Of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Site Not Available

  • Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Hangzhou Third People's Hospital

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

  • The First Affiliated Hospital Of Ningbo University

    Ningbo, Zhejiang 315100
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    WenZhou, Zhejiang 325000
    China

    Site Not Available

  • The Fourth Affiliated Hospital, Zhejiang University School Of Medicine

    Yiwu, Zhejiang 322000
    China

    Site Not Available

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