Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)
NCT ID: NCT04057573
Last Updated: 2025-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
344 participants
INTERVENTIONAL
2019-10-03
2021-10-01
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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Desert Sky Dermatology
Gilbert, Arizona, United States
Center For Dermatology Cosmetic and Laser Surgery
Fremont, California, United States
Uci Beckman Laser Institute and Medical Clinic
Irvine, California, United States
UCI Health Beckman Laser Institute and Medical Center
Irvine, California, United States
Vitiligo & Pigmentation Institute of Southern California
Los Angeles, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Dermatology Specialists Inc
Murrieta, California, United States
Dermatology Specialists Inc
Oceanside, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
Acrc Studies
San Diego, California, United States
Central Sooner Research
San Diego, California, United States
Colorado Medical Research Center Inc
Denver, Colorado, United States
Advanced Pharma Cr
Miami, Florida, United States
Leavitt Medical Associates of Florida
Ormond Beach, Florida, United States
Avita Clinical Research
Tampa, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
Ashira Dermatology Llc
Gurnee, Illinois, United States
Randall Dermatology of West Lafayette
West Lafayette, Indiana, United States
Randall Dermatology
West Lafayette, Indiana, United States
Delricht Clinical Research - Clinedge - Ppds Baton Rouge
Baton Rouge, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Tufts Medical Center
Boston, Massachusetts, United States
Metro Boston Clinical Partners
Brighton, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Henry Ford Medical Center
Detroit, Michigan, United States
Minnesota Clinical Study Center
Minneapolis, Minnesota, United States
Jdr Dermatology Research
Las Vegas, Nevada, United States
Northwell Physician Partners
New Hyde Park, New York, United States
Icahn School of Medicine At Mount Sinai
New York, New York, United States
Derm Research Center of New York Inc
Stony Brook, New York, United States
Central Sooner Research
Norman, Oklahoma, United States
Oregon Medical Research Center
Portland, Oregon, United States
Clinical Research Partners Llc
Richmond, Virginia, United States
Medical Center Unimed Eood
Sevlievo, , Bulgaria
Medical Center Unimed EOOD
Sevlievo, , Bulgaria
Diagnostic Consultative Center Ii Sofia Eood
Sofia, , Bulgaria
University Multiprofile Hospital For Active Treatment Aleksandrovska
Sofia, , Bulgaria
Diagnostic Consultative Center II Sofia EOOD
Sofia, , Bulgaria
Diagnostic Consultative Center II Sofia EOOD
Sofia, , Bulgaria
University Hospital Prof Dr Stoyan Kirkovich
Stara Zagora, , Bulgaria
University Hospital " Prof. Dr Stoyan Kirkovich"
Stara Zagora, , Bulgaria
Simcoderm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada
Kingsway Clinical Research
Etobicoke, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
Xlr8 Medical Research
Windsor, Ontario, Canada
Centre Hospitalier Universitaire de Besancon
Besançon, , France
CHU Besancon
Besançon, , France
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, , France
CHU de Bordeaux, Hospital Saint Andre
Bordeaux, , France
University Hospital Henri Mondor
Créteil, , France
CENTRE HOSpITALIER UNIVERSITAIRE HENRI MONDOR
Créteil, , France
Le Bateau Blanc
Martigues, , France
Emovis GMBH
Berlin, , Germany
Universitatsklinikum Bonn Aoer
Bonn, , Germany
Hautarztpraxis Mahlow
Mahlow, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, , Germany
University Medical Center (Universitätsmedizin der Johannes Gutenberg-Universität Mainz)
Mainz, , Germany
Policlinico S. Orsola Malpighi
Bologna, , Italy
Istituto Dermatologico San Gallicano
Rome, , Italy
Amsterdam University Medical Centre
Amsterdam, , Netherlands
Synexus Polska Sp. Z o.o. Oddział w Częstochowie
Częstochowa, , Poland
Synexus Affiliate - Krakowskie Centrum Medyczne
Krakow, , Poland
Synexus Polska Sp Z Oo Oddzial W Lodzi
Lodz, , Poland
Synexus Polska Sp Z Oo Oddzial W Czestochowie
Lublin, , Poland
Lubeskie Centrum Diagnostyczne
Świdnik, , Poland
Synexus Polska Sp. Z O.O. Oddzial Warszawie
Warsaw, , Poland
High-Med Przychodnia Specjalistycza
Warsaw, , Poland
Dermmedica Sp. Z O.O.
Wroclaw, , Poland
Ico Hospital Germans Trias I Pujol
Badalona, , Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, , Spain
Dermomedic
Madrid, , Spain
IDEI (Instituto de Dermatología Integral).
Madrid, , Spain
Hospital La Paz (Hospital Universitario La Paz )
Madrid, , Spain
Hospital Universitario de La Paz
Madrid, , 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.
Bibeau K, Butler K, Wang M, Skaltsa K, Hamzavi IH. Psychometric Evaluation of the Facial and Total Vitiligo Area Scoring Index Instruments in the TRuE-V Phase 3 Studies. Dermatol Ther (Heidelb). 2024 Aug;14(8):2223-2234. doi: 10.1007/s13555-024-01223-y. Epub 2024 Jul 30.
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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Plain Language Summary for Upload to Incyteclinicaltrials.com
Other Identifiers
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2019-000847-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 18424-307
Identifier Type: -
Identifier Source: org_study_id
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