ICP-332 in Subjects With Non-segmental Vitiligo

Launched by BEIJING INNOCARE PHARMA TECH CO., LTD. · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called ICP-332 to see if it can help people with non-segmental vitiligo, a condition where patches of skin lose their color. The study is being done in two parts and compares the effects of ICP-332 to a placebo (a treatment with no active medicine) to check how safe and effective it is.

People who may join the study are men and women between 18 and 75 years old (and in a later part, adolescents aged 12 and up who weigh at least 40 kg). Participants need to have had non-segmental vitiligo for at least 3 months, with at least 5% of their body affected and some patches on their face. Both stable and actively spreading vitiligo are allowed. Before joining, participants will be asked to sign a consent form and agree to use birth control if applicable. The study excludes those with other types of vitiligo, major health problems, or who are pregnant or breastfeeding. If you take part, you can expect to be randomly assigned to receive either ICP-332 or a placebo without knowing which one, and your skin will be monitored regularly to see how the treatment works and if there are any side effects.

Gender

ALL

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.