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

Sponsor
Incyte Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT04052425
Collaborator
(none)
330
Enrollment
57
Locations
2
Arms
25
Actual Duration (Months)
5.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
330 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants will receive ruxolitinib cream or vehicle for 24 weeks, after which they will be offered the opportunity to continue in the treatment extension period. Participants initially randomized to vehicle will be crossed over to active drug, and participants treated with ruxolitinib cream will receive an additional 28 weeks of treatment with ruxolitinib cream.Participants will receive ruxolitinib cream or vehicle for 24 weeks, after which they will be offered the opportunity to continue in the treatment extension period. Participants initially randomized to vehicle will be crossed over to active drug, and participants treated with ruxolitinib cream will receive an additional 28 weeks of treatment with ruxolitinib cream.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1): A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo
Actual Study Start Date :
Sep 20, 2019
Actual Primary Completion Date :
Mar 18, 2021
Actual Study Completion Date :
Oct 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ruxolitinib cream

Ruxolitinib cream 1.5% twice daily (BID) for 24 weeks followed by ruxolitinib cream 1.5% BID for an additional 28-week treatment extension period.

Drug: Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Other Names:
  • INCB018424 cream

    		•
    Placebo Comparator: Vehicle

    Vehicle cream for 24 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 28-week treatment extension period.

    Drug: Vehicle
    Vehicle cream is a topical formulation applied as a thin film to affected areas.

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants achieving F-VASI75 [Week 24]

      ≥ 75% improvement from baseline in Face Vitiligo Area Scoring Index (F-VASI) score.

    Secondary Outcome Measures

    1. Percentage change from baseline in facial body surface area (F-BSA) [Week 24]

    2. Proportion of participants achieving F-VASI50 [Week 24]

      ≥ 50% improvement from baseline in F-VASI score.

    3. Proportion of participants achieving F-VASI75 [Week 52]

      ≥ 75% improvement from baseline in F-VASI score.

    4. Proportion of participants achieving F-VASI90 [Week 24]

      ≥ 90% improvement from baseline in F-VASI score.

    5. Proportion of participants achieving F-VASI90 [Week 52]

      ≥ 90% improvement from baseline in F-VASI score.

    6. Proportion of participants achieving T-VASI50 [Week 24]

      ≥ 50% improvement in total body Vitiligo Area Scoring Index (T-VASI).

    7. Proportion of participants achieving T-VASI50 [Week 52]

      ≥ 50% improvement in T-VASI.

    8. Proportion of participants achieving T-VASI75 [Week 52]

      ≥ 75% improvement in T-VASI.

    9. Proportion of participants achieving a Vitiligo Noticeability Scale (VNS) of "4 - A lot less noticeable" or "5 - No longer noticeable" [Week 24]

    10. Number of treatment-emergent adverse events [Up to 56 weeks]

      Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

    11. Proportion of participants achieving F-VASI25/50/75/90 [During the treatment period (double-blind and treatment extension periods), up to 52 weeks.]

      ≥ 25%/ 50%/ 75%/90% improvement from baseline in F-VASI score.

    12. Percentage change from baseline in F-VASI [From baseline to during the treatment period (double-blind and treatment extension periods), up to 52 weeks.]

    13. Percentage change from baseline in F-BSA [From baseline to during the treatment period (double-blind and treatment extension periods), up to 52 weeks.]

    14. Percentage change from baseline in T-VASI [From baseline to during the treatment period (double-blind and treatment extension periods), up to 52 weeks.]

    15. Percentage change from baseline in total body surface area (T-BSA) [From baseline to during the treatment period (double-blind and treatment extension periods), up to 52 weeks.]

    16. Proportion of participants achieving T-VASI25/50/75/90 [During the treatment period (double-blind and treatment extension periods), up to 52 weeks.]

      ≥ 25%/ 50%/ 75%/90% improvement in T-VASI.

    17. Proportion of participants in each category of VNS [During the treatment period (double-blind and treatment extension periods), up to 52 weeks.]

    18. Population-based (trough) plasma concentrations of ruxolitinib [Week 4]

    19. Population-based (trough) plasma concentrations of ruxolitinib [Week 24]

    20. Population-based (trough) plasma concentrations of ruxolitinib [Week 40]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key 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.

    • Must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation.

    Key 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).

    • Have used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.

    • Use of protocol-defined treatments within the indicated washout period before baseline.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cahaba Dermatology Hoover Alabama United States 35244
    2 Cognitive Clinical Trials Scottsdale Btc Ppds Scottsdale Arizona United States 85260
    3 Burke Pharmaceutical Research Hot Springs National Park Arkansas United States 71913
    4 First Oc Dermatology Fountain Valley California United States 92708
    5 Marvel Clinical Research Llc Huntington Beach California United States 92647
    6 Rady Children'S Hospital - San Diego San Diego California United States 92123
    7 University of California San Francisco Sub Location San Francisco California United States 94158
    8 Clinical Research Center of Ct Danbury Connecticut United States 06810
    9 Harmony Medical Research Institute Hialeah Florida United States 33016
    10 San Marcus Research Clinic Inc. Miami Lakes Florida United States 33014
    11 ForCare Medical Center Tampa Florida United States 33613
    12 Forcare Clinical Research Fcr Forward Clinical Trials, Inc Tampa Florida United States 33624
    13 Metabolic Research Institute Inc West Palm Beach Florida United States 33401
    14 Northwestern University Chicago Illinois United States 60611
    15 Clinical Trials Management Llc Metairie Louisiana United States 70006
    16 Great Lakes Research Group Inc Bay City Michigan United States 48706
    17 Dermatology Specialists of Brighton Brighton Michigan United States 48114
    18 Suny Downstate Medical Center Brooklyn New York United States 11203
    19 Forest Hills Dermatology Group Forest Hills New York United States 11375
    20 The Dermatology Specialists Greenwich New York New York United States 10012
    21 Wake Research Associates Llc Raleigh North Carolina United States 27612
    22 Wake Forest University Winston-Salem North Carolina United States 27157
    23 Kgl Skin Study Center Broomall Pennsylvania United States 19008
    24 Dermatology Associates of Plymouth Meeting Plymouth Meeting Pennsylvania United States 19462
    25 Palmetto Clinical Trial Services Anderson South Carolina United States 29621
    26 International Clinical Research Tennessee Llc Murfreesboro Tennessee United States 37130
    27 Progressive Clinical Research San Antonio Texas United States 78213
    28 Dermatology Clinical Research Center of San Antonio San Antonio Texas United States 78229
    29 Dermatology Specialists of Spokane Spokane Washington United States 99202
    30 Multiprofile Hospital For Active Treatement - Clinic of Dermatology and Venerology Pleven Bulgaria 05800
    31 DCC 28 Sofia Bulgaria 01592
    32 Medical Center Eurohealth Sofia Bulgaria 01606
    33 Dermatology Research Institute Calgary Alberta Canada T1Y 0B4
    34 Institute For Skin Advancement Calgary Alberta Canada T3A 2N1
    35 Skin Centre For Dermatology Peterborough Ontario Canada K9J 5K2
    36 Windsor Clinical Research Inc Windsor Ontario Canada N8W 5L7
    37 McGill University Health Centre / Carey/Wang Clinic Montreal Quebec Canada H3Z2S6
    38 Siena Medical Reserch Corporation Westmount Quebec Canada H3Z 2S6
    39 Centre Hospitalier Universitaire de Nantes Nantes France 44000
    40 Chu de Nice - Hopital L'Archet 1 Nice Cedex 3 France 06202
    41 Hopital Charles Nicolle Chu Rouen - Hopital de Bois-Guillaume Rouen France 76031
    42 Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol Toulouse France 31059
    43 University Clinic Carl Gustav Carus, Technical University Dresden Dresden Germany 01307
    44 Universitatsklinik Munster Dermatologie Muenster Germany 48149
    45 Presidio Ospedaliero Piero Palagi Firenze Italy 50125
    46 Istituto Dermatologico San Gallicano Rome Italy 00144
    47 Synexus - Polska Sp Z Oo Oddzial W Gdansk Gdansk Poland 80-382
    48 Synexus Polska Sp. Z O.O. Oddzial W Gdyni Gdynia Poland 81-537
    49 Synexus - Sp Z Oo Oddzial W Katowice Katowice Poland 40-040
    50 Dermedic Dr. Zdybski Ostrowiec Poland 27-400
    51 Synexus Polska Sp. Z O.O. Oddzial W Poznaniu Poznan Poland 60-702
    52 Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz Torun Poland 87-100
    53 Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu Wroclaw Poland 50-381
    54 Hospital Cima Sanitas Barcelona Spain 08034
    55 Hospital Clinic de Barcelona Barcelona Spain 08036
    56 Hospital Universitario San Cecilio Granada Spain 18016
    57 Clinica Universidad de Navarra (Cun) Pamplona Spain 31008

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Kathleen Butler, MD, Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT04052425
    Other Study ID Numbers:
    • INCB 18424-306
    First Posted:
    Aug 9, 2019
    Last Update Posted:
    Mar 14, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Incyte Corporation
    Vitiligo
    non-segmental
    JAK inhibitor
    Additional relevant MeSH terms:
    Vitiligo

    Study Results

    No Results Posted as of Mar 14, 2022