Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo
NCT ID: NCT04530344
Last Updated: 2025-08-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
458 participants
INTERVENTIONAL
2020-09-24
2022-11-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort A : ruxolitinib cream
Participants who achieve complete or almost complete facial repigmentation (achieve ≥ F VASI90) at Week 52 in the parent study will be assigned to Cohort A and will be randomized 1:1 to ruxolitinib cream.
ruxolitinib
ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID.
Cohort A : Vehicle
Participants who achieve complete or almost complete facial repigmentation (ie, achieve ≥ F VASI90) at Week 52 in the parent study will be assigned to Cohort A and will be randomized 1:1 to vehicle cream.
Vehicle
Vehicle cream is a topical formulation applied as a thin film to affected areas.
Cohort B : roxolitinib cream
Participants who did not achieve ≥ F-VASI90 at Week 52 of the parent studies will be assigned to Cohort B and will continue ruxolitinib cream.
ruxolitinib
ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID.
Interventions
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ruxolitinib
ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID.
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
* Currently tolerating ruxolitinib cream in the parent study and no safety concerns per investigators judgment.
* Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
* Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.
* Male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child.
* Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian and written assent from the participant when possible.
Exclusion Criteria
* Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
* Pregnant or breastfeeding woman.
* Participants who live with anyone participating in any current Incyte-sponsored ruxolitinib cream study.
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_CHAIR
Incyte Corporation
Locations
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Cahaba Dermatology
Hoover, Alabama, United States
Desert Sky Dermatology
Gilbert, Arizona, United States
First Oc Dermatology
Fountain Valley, California, United States
Center For Dermatology Cosmetic and Laser Surgery
Fremont, California, United States
Marvel Clinical Research Llc
Huntington Beach, California, United States
Vitiligo & Pigmentation Institute of Southern California
Los Angeles, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Acrc Studies
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Colorado Medical Research Center Inc
Denver, Colorado, United States
Harmony Medical Research Institute
Hialeah, Florida, United States
Advanced Pharma
Miami, Florida, United States
San Marcus Research Clinic Inc.
Miami Lakes, 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
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
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
Metro Boston Clinical Partners
Brighton, Massachusetts, United States
Great Lakes Research Group Inc
Bay City, 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
Suny Downstate Medical Center
Brooklyn, New York, United States
Forest Hills Dermatology Group
Kew Gardens, New York, United States
The Dermatology Specialists Greenwich
New York, 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
Wake Research Associates Llc
Raleigh, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Central Sooner Research
Norman, Oklahoma, 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
Innovative Dermatology
Plano, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
The Dermatology and Laser Center of San Antonio
San Antonio, Texas, United States
Clinical Research Partners Llc
Richmond, Virginia, United States
Dermatology Specialists of Spokane
Spokane, Washington, United States
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 Xxviii - Sofia - Eood
Sofia, , Bulgaria
Medical Center Eurohealth
Sofia, , Bulgaria
Dermatology Research Institute
Calgary, Alberta, Canada
Simcoderm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada
Kingsway Clinical Research
Etobicoke, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
Skin Centre For Dermatology
Peterborough, Ontario, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
Xlr8 Medical Research
Windsor, Ontario, Canada
Siena Medical Research Corporation
Westmount, Quebec, Canada
Le Bateau Blanc
Martigues, , France
Hopital Archet 2 Derm Dept
Nice, , France
Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque
Pessac, , France
Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
Rouen, , France
Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol
Toulouse, , France
Universitaetsklinikum Carl Gustav Carus
Dresden, , Germany
Hautarztpraxis Mahlow
Mahlow, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, , Germany
Universitatsklinik Munster Dermatologie
Münster, , Germany
Amsterdam University Medical Centre
Amsterdam, , Netherlands
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
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
Dermedic Dr. Zdybski
Ostrowiec Świętokrzyski, , Poland
Synexus Polska Sp. Z O.O. Oddzial W Poznaniu
Poznan, , Poland
Lubeskie Centrum Diagnostyczne
Świdnik, , Poland
Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz
Torun, , Poland
Synexus Polska Sp. Z O.O. Oddzial Warszawie
Warsaw, , Poland
High-Med Przychodnia Specjalistycza
Warsaw, , Poland
Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu
Wroclaw, , Poland
Dermmedica Sp. Z O.O.
Wroclaw, , Poland
Ico Hospital Germans Trias I Pujol
Badalona, , Spain
Dermomedic
Madrid, , 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-000987-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 18424-308
Identifier Type: -
Identifier Source: org_study_id
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