Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)
NCT ID: NCT04052425
Last Updated: 2025-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
330 participants
INTERVENTIONAL
2019-09-20
2021-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Double-Blind Period: Ruxolitinib cream 1.5% BID
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.
Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Double-Blind Period: Vehicle cream BID
Participants applied matching vehicle cream BID for 24 weeks.
Vehicle
Vehicle cream is a topical formulation applied as a thin film to affected areas.
Treatment-Extension Period: Ruxolitinib cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.
Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Treatment-Extension Period: Vehicle cream to Ruxolitinib cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5%m BID for 28 weeks in the Treatment-Extension Period.
Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle
Vehicle cream is a topical formulation applied as a thin film to affected areas.
Interventions
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Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle
Vehicle cream is a topical formulation applied as a thin film to affected areas.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
12 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Kathleen Butler, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Cahaba Dermatology
Hoover, Alabama, United States
Cognitive Clinical Trials Scottsdale Btc Ppds
Scottsdale, Arizona, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
First Oc Dermatology
Fountain Valley, California, United States
Marvel Clinical Research Llc
Huntington Beach, California, United States
Rady Children'S Hospital - San Diego
San Diego, California, United States
University of California San Francisco Sub Location
San Francisco, California, United States
Clinical Research Center of Ct
Danbury, Connecticut, United States
Harmony Medical Research Institute
Hialeah, Florida, United States
San Marcus Research Clinic Inc.
Miami Lakes, Florida, United States
ForCare Medical Center
Tampa, Florida, United States
Forcare Clinical Research Fcr Forward Clinical Trials, Inc
Tampa, Florida, United States
Metabolic Research Institute Inc
West Palm Beach, Florida, United States
Northwestern University
Chicago, Illinois, United States
Clinical Trials Management Llc
Metairie, Louisiana, United States
Great Lakes Research Group Inc
Bay City, Michigan, United States
Dermatology Specialists of Brighton
Brighton, Michigan, United States
Suny Downstate Medical Center
Brooklyn, New York, United States
Forest Hills Dermatology Group
Forest Hills, New York, United States
The Dermatology Specialists Greenwich
New York, New York, United States
Wake Research Associates Llc
Raleigh, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Kgl Skin Study Center
Broomall, Pennsylvania, United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States
Palmetto Clinical Trial Services
Anderson, South Carolina, United States
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee, United States
Progressive Clinical Research
San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Dermatology Specialists of Spokane
Spokane, Washington, United States
Multiprofile Hospital For Active Treatement - Clinic of Dermatology and Venerology
Pleven, , Bulgaria
DCC 28
Sofia, , Bulgaria
Medical Center Eurohealth
Sofia, , Bulgaria
Dermatology Research Institute
Calgary, Alberta, Canada
Institute For Skin Advancement
Calgary, Alberta, Canada
Skin Centre For Dermatology
Peterborough, Ontario, Canada
Windsor Clinical Research Inc
Windsor, Ontario, Canada
McGill University Health Centre / Carey/Wang Clinic
Montreal, Quebec, Canada
Siena Medical Reserch Corporation
Westmount, Quebec, Canada
Centre Hospitalier Universitaire de Nantes
Nantes, , France
Chu de Nice - Hopital L'Archet 1
Nice, , France
Hopital Charles Nicolle Chu Rouen - Hopital de Bois-Guillaume
Rouen, , France
Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol
Toulouse, , France
University Clinic Carl Gustav Carus, Technical University Dresden
Dresden, , Germany
Universitatsklinik Munster Dermatologie
Münster, , Germany
Presidio Ospedaliero Piero Palagi
Florence, , Italy
Istituto Dermatologico San Gallicano
Rome, , Italy
Synexus - Polska Sp Z Oo Oddzial W Gdansk
Gdansk, , Poland
Synexus Polska Sp. Z O.O. Oddzial W Gdyni
Gdynia, , Poland
Synexus - Sp Z Oo Oddzial W Katowice
Katowice, , Poland
Dermedic Dr. Zdybski
Ostrowiec, , Poland
Synexus Polska Sp. Z O.O. Oddzial W Poznaniu
Poznan, , Poland
Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz
Torun, , Poland
Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu
Wroclaw, , Poland
Hospital Cima Sanitas
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario San Cecilio
Granada, , Spain
Clinica Universidad de Navarra (Cun)
Pamplona, , Spain
Countries
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References
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Rosmarin D, Pandya AG, Passeron T, Forman SB, Zdybski J, Amster M, Feser C, Papp KA, Nuara A, Kornacki D, Wei S, Ren H, Harris JE, Ezzedine K. Long-Term Integrated Safety Summary of Ruxolitinib Cream in Phase 3 Clinical Trials of Patients with Vitiligo. Dermatol Ther (Heidelb). 2025 Oct 22. doi: 10.1007/s13555-025-01555-3. Online ahead of print.
Seneschal J, Wolkerstorfer A, Desai SR, Grimes P, Ezzedine K, Pandya AG, Kornacki D, Wei S, Passeron T, Rosmarin D. Efficacy and Safety of Ruxolitinib Cream in Vitiligo by Patient Characteristic Subgroups: Descriptive Pooled Analysis From Two Phase 3 Studies. Dermatol Ther (Heidelb). 2025 May;15(5):1227-1238. doi: 10.1007/s13555-025-01381-7. Epub 2025 Mar 29.
Rosmarin D, Passeron T, Pandya AG, Grimes P, Harris JE, Desai SR, Lebwohl M, Ruer-Mulard M, Seneschal J, Wolkerstorfer A, Kornacki D, Sun K, Butler K, Ezzedine K; TRuE-V Study Group. Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo. N Engl J Med. 2022 Oct 20;387(16):1445-1455. doi: 10.1056/NEJMoa2118828.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Results Plain Language Summary for Upload to Incyteclinicaltrials.com
Other Identifiers
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2019-000846-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 18424-306
Identifier Type: -
Identifier Source: org_study_id
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