Vitiligo

A Study to Assess the Safety and Efficacy of Ruxolitinib Cream in Participants with Genital Vitiligo

Incyte Study ID:
INCB 18424-219
CT.gov ID:
NCT05750823
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Clinical Study Purpose

An open-label study in which participants with non-segmental vitiligo with genital involvement will apply ruxolitinib 1.5% cream twice a day (BID) to all depigmented areas (up to 10% BSA) for up to 48 weeks. Participants should continue to treat depigmented areas identified for treatment at baseline regardless of whether the area begins to improve or fully repigment.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Vitiligo
    • PRODUCT
  • Drug: Ruxolitinib Cream
    • COLLABORATORS
    N/A
    DATE
    Apr 2023 - Mar 2025
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Clinical diagnosis of nonsegmental vitiligo with genital involvement
    • At least ≥ 0.25% BSA of nonsegmental vitiligo in the genital area.

    Exclusion Criteria

    • Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other
    • skin depigmentation disorders.

    Clinical Study Locations

    Location
    Status
    Location
    RESEARCH TORONTO
    TORONTO, ON, Canada, M3H 5Y8
    Status
    Recruiting
    Location
    SKIN CENTRE FOR DERMATOLOGY
    PETERBOROUGH, ON, Canada, K9J 5K2
    Status
    Recruiting
    Location
    SIMCOMED HEALTH LTD
    BARRIE, ON, Canada, L4M 7G1
    Status
    Recruiting
    Location
    DERMATOLOGY RESEARCH INSTITUTE
    CALGARY, AB, Canada, T2J 7E1
    Status
    Recruiting
    Location
    APEX CLINICAL RESEARCH CENTER
    MAYFIELD, OH, US, 44124
    Status
    Recruiting
    Location
    AUSTIN INSTITUTE FOR CLINICAL RESEARCH AICR PFLUGERVILLE
    PFLUGERVILLE, TX, US, 78660
    Status
    Recruiting

    Protocol Summary

    Incyte Study ID:
    INCB 18424-219
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    49
    Primary Outcome
    Open

    Proportion of participants achieving a genital Vitiligo Noticeable Score (VNS) of 4 or 5

    Timeframe: Week 48

    Secondary Outcome
    Open

    Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Timeframe: 52 weeks

    Proportion of participants achieving Genital- Physician Global Vitiligo Assessment (PhGVA)

    Timeframe: Week 48

    Change from baseline in affected Body Surface Area BSA in the genital region

    Timeframe: Week 24 and 48

    Proportion of participants achieving T-VASI50/75/90

    Timeframe: Week 24 and 48

    Proportion of participants achieving a genital Vitiligo Noticeable Score (VNS) of 4 or 5

    Timeframe: Week 24

    Proportion of participants in each category of the color-matching question

    Timeframe: Week 24 and 48