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ICP-332 in Subjects With Non-...

ICP-332 in Subjects With Non-segmental Vitiligo

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

603 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-09

Study Completion Date

2029-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Non Segmental Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ICP-332 dose A（Phase2）

Group Type EXPERIMENTAL

ICP-332 Tablets

Intervention Type DRUG

ICP-332 will be administered as tablet

Placebo（Phase2）

Group Type PLACEBO_COMPARATOR

ICP-332 Placebo Tablets

Intervention Type DRUG

ICP-332 Placebo will be administered as tablet

ICP-332 dose B（Phase2:）

Group Type EXPERIMENTAL

ICP-332 Tablets

Intervention Type DRUG

ICP-332 will be administered as tablet

ICP-332 dose A or dose B（Phase3）

Group Type EXPERIMENTAL

ICP-332 Tablets

Intervention Type DRUG

ICP-332 will be administered as tablet

Placebo（Phase3）

Group Type PLACEBO_COMPARATOR

ICP-332 Placebo Tablets

Intervention Type DRUG

ICP-332 Placebo will be administered as tablet

Interventions

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ICP-332 Tablets

ICP-332 will be administered as tablet

Intervention Type DRUG

ICP-332 Placebo Tablets

ICP-332 Placebo will be administered as tablet

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Exclusion Criteria

1. Any of the following vitiligo related medical conditions and other skin diseases/conditions.

Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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