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NCT Number: NCT07047612

ICP-332 in Subjects With Non-segmental Vitiligo

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.

Recruiting

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Key information

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

  • 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.

Treatment and study plan

ICP-332 Tablets

Drug

ICP-332 will be administered as tablet

ICP-332 placebo Tablets

Drug

ICP-332 Placebo will be administered as tablet

Primary outcomes

  1. Phase2: Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24.

    Time frame: 24 weeks

  2. Phase3: Proportion of subjects achieving F-VASI 75 at Week 52.

    Time frame: 52 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Flora Xiang, Doctor

CONTACT

[email protected]

021-52887775

Sponsors and collaborators

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 2, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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