Vitiligo

Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)

Incyte Study ID:
INCB 18424-306
CT.gov ID:
NCT04052425
View Results Summary
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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Results Available

Plain Language Summary
Available Languages: English
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Protocol
Available Languages: English
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Statistical Analysis Plan (SAP)
Available Languages: English
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Clinical Study Purpose

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Vitiligo
    • PRODUCT
  • Drug: Ruxolitinib cream
  • Drug: Vehicle
    • COLLABORATORS
    N/A
    DATE
    Sep 2019 - Mar 2021
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    12+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    COGNITIVE CLINICAL TRIALS SCOTTSDALE BTC PPDS
    SCOTTSDALE, AZ, US, 85260
    Name
    BURKE PHARMACEUTICAL RESEARCH
    HOT SPRINGS NATIONAL PARK, AR, US, 71913
    Name
    MARVEL CLINICAL RESEARCH LLC
    HUNTINGTON BEACH, CA, US, 92647
    Name
    CLINICAL RESEARCH CENTER OF CT
    DANBURY, CT, US, 06810
    Name
    HARMONY MEDICAL RESEARCH INSTITUTE
    HIALEAH, FL, US, 33016
    Name
    SAN MARCUS RESEARCH CLINIC INC.
    MIAMI LAKES, FL, US, 33014

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI, and total body vitiligo area (facial and nonfacial) not exceeding 10% BSA.
    • Agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.

    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).

    Protocol Summary

    Incyte Study ID:
    INCB 18424-306
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Crossover Assignment
    Masking:
    Triple (Participant, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    330
    Primary Outcome
    Open

    Proportion of participants achieving F-VASI75

    Timeframe: Week 24

    Secondary Outcome
    Open

    Percentage change from baseline in facial body surface area (F-BSA)

    Timeframe: Week 24

    Proportion of participants achieving F-VASI50

    Timeframe: Week 24

    Proportion of participants achieving F-VASI75

    Timeframe: Week 52

    Proportion of participants achieving F-VASI90

    Timeframe: Week 24

    Proportion of participants achieving F-VASI90

    Timeframe: Week 52

    Proportion of participants achieving T-VASI50

    Timeframe: Week 24

    Proportion of participants achieving T-VASI50

    Timeframe: Week 52

    Proportion of participants achieving T-VASI75

    Timeframe: Week 52

    Proportion of participants achieving a Vitiligo Noticeability Scale (VNS) of "4 - A lot less noticeable" or "5 - No longer noticeable"

    Timeframe: Week 24

    Number of treatment-emergent adverse events

    Timeframe: Up to 56 weeks

    Proportion of participants achieving F-VASI25/50/75/90

    Timeframe: During the treatment period (double-blind and treatment extension periods), up to 52 weeks.

    Percentage change from baseline in F-VASI

    Timeframe: From baseline to during the treatment period (double-blind and treatment extension periods), up to 52 weeks.

    Percentage change from baseline in F-BSA

    Timeframe: From baseline to during the treatment period (double-blind and treatment extension periods), up to 52 weeks.

    Percentage change from baseline in T-VASI

    Timeframe: From baseline to during the treatment period (double-blind and treatment extension periods), up to 52 weeks.

    Percentage change from baseline in total body surface area (T-BSA)

    Timeframe: From baseline to during the treatment period (double-blind and treatment extension periods), up to 52 weeks.

    Proportion of participants achieving T-VASI25/50/75/90

    Timeframe: During the treatment period (double-blind and treatment extension periods), up to 52 weeks.

    Proportion of participants in each category of VNS

    Timeframe: During the treatment period (double-blind and treatment extension periods), up to 52 weeks.

    Population-based (trough) plasma concentrations of ruxolitinib

    Timeframe: Week 4

    Population-based (trough) plasma concentrations of ruxolitinib

    Timeframe: Week 24

    Population-based (trough) plasma concentrations of ruxolitinib

    Timeframe: Week 40