ICP-332 in Subjects With Non-segmental Vitiligo

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Non Segmental Vitiligo

In brief

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.

Key facts

Study ID

NCT07047612

Run by

Beijing InnoCare Pharma Tech Co., Ltd.

People needed

603

Starts

2025-05-09

Expected to finish

2029-04-01

Last updated by the study team

2025-08-07

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• Huashan Hospital Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• Chongqing Traditional Chinese Medicine Hospital — Chongqing, Chongqing Municipality, China (enrolling)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)
• Hangzhou Third People's Hospital — Hangzhou, Zhejiang, China (enrolling)
• Beijing Tongren Hospital — Beijing, Beijing Municipality, China
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
• Union Hospital affiliated to Fujian Medical — Fuzhou, Fujian, China
• The First Affiliated Hospital of Fujian Medical — Fuzhou, Fujian, China
• Sun Yat-sen Memorial Hospital,Sun Yat-sen University — Guangzhou, Guangdong, China
• Deramatology Hospital of Southern Medical Univercity — Guangzhou, Guangdong, China
• Nanfang Hospital — Guangzhou, Guangdong, China
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
• The Second Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China
• Nanyang First People's Hospital — Nanyang, Henan, China
• The First Affiliated Hospital of Xinxiang Medical College — Weihui, Henan, China
• Henan Provincial People's Hospital — Zhengzhou, Henan, China
• Zhengzhou Central Hospital Affiliated to Zhengzhou University — Zhengzhou, Henan, China
• Jingzhou Central Hospital — Jingzhou, Hubei, China
• Shiyan People's Hospital — Shiyan, Hubei, China
• Wuhan NO.1 Hospital(Wuhan Hospital of Traditional Chinese and Western Medicine) — Wuhan, Hubei, China
• Xiangya Hospital of Central South University — Changsha, Hunan, China
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China
• The First Affiliated Hospital of University Of South China — Hengyang, Hunan, China
• The First People's Hospital of Lianyungang — Lianyungang, Jiangsu, China
• Hospital for Skin Diseases, Chinese Academy of Medical Sciences — Nanjing, Jiangsu, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.