ICP-332 in Subjects With Non-segmental Vitiligo

Not Applicable

Recruiting

• Conditions: Non Segmental Vitiligo
• Interventions: Drug: ICP-332 Tablets; Drug: ICP-332 Placebo Tablets

• Registration Number: NCT07047612
• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-05-09
• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-23
• Study First Posted: 2025-07-02
• Last Update Submitted: 2025-08-05
• Last Update Posted: 2025-08-07
• Primary Completion: 2029-04
• Study Completion: 2029-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 603

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICP-332 dose A（Phase2）	ICP-332 Tablets	-
Placebo（Phase2）	ICP-332 Placebo Tablets	-
ICP-332 dose B（Phase2:）	ICP-332 Tablets	-
ICP-332 dose A or dose B（Phase3）	ICP-332 Tablets	-
Placebo（Phase3）	ICP-332 Placebo Tablets	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (45)

The Second Affiliated Hospital of Wannan Medical College; 🇨🇳 Wuhu, Anhui, China

Beijing Chao-yang Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Tongren Hospital; 🇨🇳 Beijing, Beijing, China

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China

The Second Affiliated Hospital of Henan University of Science and Technology; 🇨🇳 Luoyang, Henan, China

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

Zhengzhou Central Hospital Affiliated to Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Shiyan People's Hospital; 🇨🇳 Shiyan, Hubei, China

The First Affiliated Hospital of University Of South China; 🇨🇳 Hengyang, Hunan, China

Shenyang Medical College Affiliated Central Hospital; 🇨🇳 Shenyang, Liaoning, China

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