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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04052425
Recruitment Status : Active, not recruiting
First Posted : August 9, 2019
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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
Non-segmental Vitiligo Drug: Ruxolitinib cream Drug: Vehicle Phase 3

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Study Type : Interventional  (Clinical Trial)
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.
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 : September 20, 2019
Estimated Primary Completion Date : April 16, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

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 Name: 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.




Primary Outcome Measures :
  1. Proportion of participants achieving F-VASI75 [ Time Frame: 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) [ Time Frame: Week 24 ]
  2. Proportion of participants achieving F-VASI50 [ Time Frame: Week 24 ]
    ≥ 50% improvement from baseline in F-VASI score.

  3. Proportion of participants achieving F-VASI75 [ Time Frame: Week 52 ]
    ≥ 75% improvement from baseline in F-VASI score.

  4. Proportion of participants achieving F-VASI90 [ Time Frame: Week 24 ]
    ≥ 90% improvement from baseline in F-VASI score.

  5. Proportion of participants achieving F-VASI90 [ Time Frame: Week 52 ]
    ≥ 90% improvement from baseline in F-VASI score.

  6. Proportion of participants achieving T-VASI50 [ Time Frame: Week 24 ]
    ≥ 50% improvement in total body Vitiligo Area Scoring Index (T-VASI).

  7. Proportion of participants achieving T-VASI50 [ Time Frame: Week 52 ]
    ≥ 50% improvement in T-VASI.

  8. Proportion of participants achieving T-VASI75 [ Time Frame: 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" [ Time Frame: Week 24 ]
  10. Number of treatment-emergent adverse events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: During the treatment period (double-blind and treatment extension periods), up to 52 weeks. ]
  18. Population-based (trough) plasma concentrations of ruxolitinib [ Time Frame: Week 4 ]
  19. Population-based (trough) plasma concentrations of ruxolitinib [ Time Frame: Week 24 ]
  20. Population-based (trough) plasma concentrations of ruxolitinib [ Time Frame: Week 40 ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052425


Locations
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United States, Alabama
Cahaba Dermatology
Hoover, Alabama, United States, 35244
United States, Arizona
Cognitive Clinical Trials Scottsdale Btc Ppds
Scottsdale, Arizona, United States, 85260
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs National Park, Arkansas, United States, 71913
United States, California
First Oc Dermatology
Fountain Valley, California, United States, 92708
Marvel Clinical Research Llc
Huntington Beach, California, United States, 92647
Rady Children'S Hospital - San Diego
San Diego, California, United States, 92123
University of California San Francisco Sub Location
San Francisco, California, United States, 94158
United States, Connecticut
Clinical Research Center of Ct
Danbury, Connecticut, United States, 06810
United States, Florida
Harmony Medical Research Institute
Hialeah, Florida, United States, 33016
San Marcus Research Clinic Inc.
Miami Lakes, Florida, United States, 33014
ForCare Medical Center
Tampa, Florida, United States, 33613
Forcare Clinical Research Fcr Forward Clinical Trials, Inc
Tampa, Florida, United States, 33624
Metabolic Research Institute Inc
West Palm Beach, Florida, United States, 33401
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Louisiana
Clinical Trials Management Llc
Metairie, Louisiana, United States, 70006
United States, Michigan
Great Lakes Research Group Inc
Bay City, Michigan, United States, 48706
Dermatology Specialists of Brighton
Brighton, Michigan, United States, 48114
United States, New York
Suny Downstate Medical Center
Brooklyn, New York, United States, 11203
Forest Hills Dermatology Group
Forest Hills, New York, United States, 11375
The Dermatology Specialists Greenwich
New York, New York, United States, 10012
United States, North Carolina
Wake Research Associates Llc
Raleigh, North Carolina, United States, 27612
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Kgl Skin Study Center
Broomall, Pennsylvania, United States, 19008
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States, 19462
United States, South Carolina
Palmetto Clinical Trial Services
Anderson, South Carolina, United States, 29621
United States, Tennessee
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee, United States, 37130
United States, Texas
Progressive Clinical Research
San Antonio, Texas, United States, 78213
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
Dermatology Specialists of Spokane
Spokane, Washington, United States, 99202
Bulgaria
Multiprofile Hospital For Active Treatement - Clinic of Dermatology and Venerology
Pleven, Bulgaria, 05800
DCC 28
Sofia, Bulgaria, 01592
Medical Center Eurohealth
Sofia, Bulgaria, 01606
Canada, Alberta
Dermatology Research Institute
Calgary, Alberta, Canada, T1Y 0B4
Institute For Skin Advancement
Calgary, Alberta, Canada, T3A 2N1
Canada, Ontario
Skin Centre For Dermatology
Peterborough, Ontario, Canada, K9J 5K2
Windsor Clinical Research Inc
Windsor, Ontario, Canada, N8W 5L7
Canada, Quebec
McGill University Health Centre / Carey/Wang Clinic
Montreal, Quebec, Canada, H3Z2S6
Siena Medical Reserch Corporation
Westmount, Quebec, Canada, H3Z 2S6
France
Centre Hospitalier Universitaire de Nantes
Nantes, France, 44000
Chu de Nice - Hopital L'Archet 1
Nice Cedex 3, France, 06202
Hopital Charles Nicolle Chu Rouen - Hopital de Bois-Guillaume
Rouen, France, 76031
Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol
Toulouse, France, 31059
Germany
University Clinic Carl Gustav Carus, Technical University Dresden
Dresden, Germany, 01307
Universitatsklinik Munster Dermatologie
Muenster, Germany, 48149
Italy
Presidio Ospedaliero Piero Palagi
Firenze, Italy, 50125
Istituto Dermatologico San Gallicano
Rome, Italy, 00144
Poland
Synexus - Polska Sp Z Oo Oddzial W Gdansk
Gdansk, Poland, 80-382
Synexus Polska Sp. Z O.O. Oddzial W Gdyni
Gdynia, Poland, 81-537
Synexus - Sp Z Oo Oddzial W Katowice
Katowice, Poland, 40-040
Dermedic Dr. Zdybski
Ostrowiec, Poland, 27-400
Synexus Polska Sp. Z O.O. Oddzial W Poznaniu
Poznan, Poland, 60-702
Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz
Torun, Poland, 87-100
Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu
Wroclaw, Poland, 50-381
Spain
Hospital Cima Sanitas
Barcelona, Spain, 08034
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital Universitario San Cecilio
Granada, Spain, 18016
Clinica Universidad de Navarra (Cun)
Pamplona, Spain, 31008
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Kathleen Butler, MD Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04052425    
Other Study ID Numbers: INCB 18424-306
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases