Vitiligo

A study to evaluate the safety and efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo

Incyte Study ID:
INCB 18424-217
CT.gov ID:
NCT05247489
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
Subscribe to Updates

Clinical Study Purpose

The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream with or without phototherapy in adolescent and adult participants with non-segmental vitiligo for whom vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Vitiligo
    • PRODUCT
  • Drug: Ruxolitinib 1.5% cream
    • COLLABORATORS
    N/A
    DATE
    May 2022 - Dec 2023
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    12 - 99 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • A clinical diagnosis of nonsegmental vitiligo with depigmented area including all of the
    • following:

    Exclusion Criteria

    • No pigmented hair within any of the vitiligo areas on the face.
    • Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other

    Clinical Study Locations

    Location
    Status
    Location
    LYNDERM RESEARCH INC
    MARKHAM, ON, Canada, L3P 1X2
    Status
    Recruiting
    Location
    SIMCOMED HEALTH LTD
    BARRIE, ON, Canada, L4M 7G1
    Status
    Recruiting
    Location
    PRINCIPLE RESEARCH SOLUTIONS
    SPOKANE, WA, US, 99202
    Status
    Recruiting
    Location
    FIRST OC DERMATOLOGY
    FOUNTAIN VALLEY, CA, US, 92708
    Status
    Recruiting
    Location
    AUSTIN INSTITUTE FOR CLINICAL RESEARCH AICR PFLUGERVILLE
    PFLUGERVILLE, TX, US, 78660
    Status
    Recruiting
    Location
    METRO BOSTON CLINICAL PARTNERS
    BRIGHTON, MA, US, 02135
    Status
    Recruiting

    Protocol Summary

    Incyte Study ID:
    INCB 18424-217
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    55
    Primary Outcome
    Open

    Change from Baseline in T-VASI

    Timeframe: Week 48

    Secondary Outcome
    Open

    Number of treatment-related adverse events

    Timeframe: Approximately 14 months

    Percentage of participants achieving F-VASI50/75/90 at each post-baseline visit

    Timeframe: Weeks 4, 8, 12, 16, 24, 32, 40 and 48

    Percentage of participants achieving T-VASI50/75/90 at each post-baseline visit

    Timeframe: Weeks 4, 8, 12, 16, 24, 32, 40 and 48

    Percentage change from baseline in F-VASI at each post-baseline visit

    Timeframe: Weeks 4, 8, 12, 16, 24, 32, 40 and 48

    Percentage change from baseline in T-VASI at each post-baseline visit

    Timeframe: Weeks 4, 8, 12, 16, 24, 32, 40 and 48

    Percentage change from baseline in F-BSA at each post-baseline visit

    Timeframe: Weeks 4, 8, 12, 16, 24, 32, 40 and 48

    Percentage change from baseline in T-BSA at each post-baseline visit

    Timeframe: Weeks 4, 8, 12, 16, 24, 32, 40 and 48

    Population-based (trough) plasma concentrations of ruxolitinib

    Timeframe: Weeks 4, 12, and 16