ICP-332 in Subjects With 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
Beijing InnoCare Pharma Tech Co., Ltd.
603 participants
May 9, 2025
INTERVENTIONAL
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.
Eligibility
Inclusion Criteria12
- 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.
- 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.
Exclusion Criteria1
- Any of the following vitiligo related medical conditions and other skin diseases/conditions.
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Interventions
ICP-332 will be administered as tablet
ICP-332 Placebo will be administered as tablet
Locations(45)
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NCT07047612