ICP-332 in Subjects With Non-segmental Vitiligo

InnoCare Pharma

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Non Segmental Vitiligo

Treatments: Drug: ICP-332 Placebo Tablets; Drug: ICP-332 Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07047612

ICP-CL-00607

Details and patient eligibility

About

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.

Enrollment: 603 estimated patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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603 participants in 5 patient groups, including a placebo group

ICP-332 dose A（Phase2）

Experimental group

Treatment:

Drug: ICP-332 Tablets

Placebo（Phase2）

Placebo Comparator group

Treatment:

Drug: ICP-332 Placebo Tablets

ICP-332 dose B（Phase2:）

Experimental group

Treatment:

Drug: ICP-332 Tablets

ICP-332 dose A or dose B（Phase3）

Experimental group

Treatment:

Drug: ICP-332 Tablets

Placebo（Phase3）

Placebo Comparator group

Treatment:

Drug: ICP-332 Placebo Tablets