ICP-332 treatment for 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

This trial will test whether oral ICP-332 tablets help people with non-segmental vitiligo (including adolescents in the Phase III part) who have at least 5% body surface area affected and facial involvement regain skin pigment better than placebo.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 603 (estimated)
• Ages: 12 Years to 75 Years
• Sex: All
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry-sponsored)
• Locations: 45 sites (Wuhu, Anhui and 44 other locations)
• Trial ID: NCT07047612 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled, parallel-group, adaptive Phase II/III multi-center trial with distinct Phase 2 and Phase 3 portions. Eligible participants have non-segmental vitiligo for at least three months with total body VASI between 5 and 50, facial VASI ≥0.5, at least 5% body surface area affected, and meet age and weight criteria for the relevant phase. Participants are randomized to receive oral ICP-332 tablets or matching placebo and are followed for efficacy and safety outcomes related to repigmentation and tolerability. Sites for the trial are located in China at affiliated hospitals in Wuhu and at Peking University Third Hospital in Beijing.

Who should consider this trial

Good fit: Ideal candidates are people with non-segmental vitiligo (≥3 months), total body involvement of at least 5% including ≥0.5% facial involvement, T-VASI between 5 and 50 and F-VASI ≥0.5, who meet the age and weight requirements for the trial phase.

Not a fit: People with segmental vitiligo, other interfering skin diseases, disease extent outside the trial's VASI range, adolescents under 40 kg, or those who cannot use required contraception or attend study visits are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, ICP-332 could become an effective oral option to restore pigment and improve appearance for people with non-segmental vitiligo.

How similar studies have performed: Some other targeted vitiligo therapies (for example topical and systemic JAK inhibitors) have shown benefit in clinical trials, but ICP-332 is a novel oral agent that is still being tested in Phase II/III.

Eligibility criteria

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.

Where this trial is running

Wuhu, Anhui and 44 other locations

• The First Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China (Not_yet_recruiting)
• Peking University Third Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing Chao-yang Hospital,Capital Medical University — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing Tongren Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Chongqing Traditional Chinese Medicine Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
• Union Hospital affiliated to Fujian Medical — Fuzhou, Fujian, China (Not_yet_recruiting)
• The First Affiliated Hospital of Fujian Medical — Fuzhou, Fujian, China (Not_yet_recruiting)
• Sun Yat-sen Memorial Hospital,Sun Yat-sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Deramatology Hospital of Southern Medical Univercity — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Nanfang Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (Not_yet_recruiting)
• Nanyang First People's Hospital — Nanyang, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xinxiang Medical College — Weihui, Henan, China (Not_yet_recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Zhengzhou Central Hospital Affiliated to Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Jingzhou Central Hospital — Jingzhou, Hubei, China (Not_yet_recruiting)
• Shiyan People's Hospital — Shiyan, Hubei, China (Not_yet_recruiting)
• Wuhan NO.1 Hospital(Wuhan Hospital of Traditional Chinese and Western Medicine) — Wuhan, Hubei, China (Not_yet_recruiting)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• The First Affiliated Hospital of University Of South China — Hengyang, Hunan, China (Not_yet_recruiting)
• The First People's Hospital of Lianyungang — Lianyungang, Jiangsu, China (Not_yet_recruiting)
• Hospital for Skin Diseases, Chinese Academy of Medical Sciences — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Suzhou Municipal Hospital — Suzhou, Jiangsu, China (Not_yet_recruiting)
• Dermatology hospital of jiangxi province — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The first hospital of Jilin Univercity — Changchun, Jilin, China (Not_yet_recruiting)
• Shenyang Medical College Affiliated Central Hospital — Shenyang, Liaoning, China (Not_yet_recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
• Shandong First Medical University Affiliated Dermatology Hospital (Shandong Institute of Dermatology and Venereology, Shandong Dermatology Hospital) — Jinan, Shandong, China (Not_yet_recruiting)
• Zibo Central Hospital — Zibo, Shandong, China (Not_yet_recruiting)
• Huashan Hospital Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai Dermatology Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shaanxi Provincial People's Hospital — Xian, Shanxi, China (Not_yet_recruiting)
• Chengdu Second People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• The First Affiliated Hospital Of Kunming Medical University — Kunming, Yunnan, China (Not_yet_recruiting)
• Hangzhou Third People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
• Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• The First Affiliated Hospital Of Ningbo University — Ningbo, Zhejiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Not_yet_recruiting)
• The Fourth Affiliated Hospital, Zhejiang University School Of Medicine — Yiwu, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Flora Xiang, Doctor

Conditions Non Segmental Vitiligo