Vitiligo

A Study to evaluate the mechanism of action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)

Incyte Study ID:
INCB 18424-214
CT.gov ID:
NCT04896385
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

The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Vitiligo
    • PRODUCT
  • Drug: Ruxolitinib cream
  • Drug: Vehicle Cream
    • COLLABORATORS
    N/A
    DATE
    Jun 2021 - Nov 2022
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • A clinical diagnosis of nonsegmental vitiligo with depigmented areas including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, and ≥ 3 T-VASI; total body vitiligo area (facial and nonfacial) should not exceed 50% BSA.
    • At least 1 active vitiligo lesion (eg, such as confetti lesion, trichrome appearance, pinkish

    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 skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).

    Clinical Study Locations

    Location
    Status
    Location
    FIRST OC DERMATOLOGY
    FOUNTAIN VALLEY, CA, US, 92708
    Status
    Active, not recruiting
    Location
    DERMATOLOGY SPECIALISTS OF SPOKANE
    SPOKANE, WA, US, 99202
    Status
    Active, not recruiting
    Location
    DERMATOLOGY RESEARCH INSTITUTE
    CALGARY, AB, Canada, T1Y 0B4
    Status
    Active, not recruiting
    Location
    JRB RESEARCH INC
    OTTAWA, ON, Canada, K1H 7X8
    Status
    Active, not recruiting
    Location
    SIMCODERM MEDICAL AND SURGICAL DERMATOLOGY CENTER
    BARRIE, ON, Canada, L4M 7G1
    Status
    Active, not recruiting
    Location
    LYNDERM RESEARCH INC
    MARKHAM, ON, Canada, L3P 1X2
    Status
    Active, not recruiting

    Protocol Summary

    Incyte Study ID:
    INCB 18424-214
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Crossover Assignment
    Masking:
    Triple (Participant, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    60
    Primary Outcome
    Open

    To evaluate change in Immune Biomarkers

    Timeframe: First 24 weeks of study

    Secondary Outcome
    Open

    Correlation of CXCL10 biomarker to Vitiligo Area Scoring Index (VASI) Repigmentation response in target lesions

    Timeframe: First 24 weeks of study

    Number of treatment emergency Adverse Events

    Timeframe: 56 weeks