A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)
NCT ID: NCT06113445
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
467 participants
INTERVENTIONAL
2023-11-29
2027-02-24
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
TRIPLE
Study Groups
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Experimental: Povorcitinib Dose A
Participants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
Povorcitinib
Oral, Tablet
Placebo
Participants will receive Placebo for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
Placebo
Oral, Tablet
Interventions
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Povorcitinib
Oral, Tablet
Placebo
Oral, Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of nonsegmental vitiligo and meet the following:
* T-BSA ≥ 5%
* T-VASI score ≥ 4
* F-BSA ≥ 0.5%
* F-VASI score ≥ 0.5
* Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.
* Willingness to avoid pregnancy or fathering children.
Exclusion Criteria
* Clinically significant abnormal TSH or free T4 at screening.
* Use of laser or phototherapy within 8 weeks and dihydroxyacetone within 4 weeks prior to Day 1.
* Current or past use of the depigmenting agent monobenzyl ether of hydroquinone including Benoquin®.
* History of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo.
* Spontaneous and significant repigmentation within 6 months prior to screening.
* Women who are pregnant, considering pregnancy, or breast feeding.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or recurrent dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
* Evidence of infection with TB, HBV, HCV or HIV.
* History of failure to JAK inhibitor treatment of any inflammatory disease.
* Laboratory values outside of the protocol-defined ranges.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Incyte Medical Monitor
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Cahaba Dermatology
Hoover, Alabama, United States
University of California Irvine
Irvine, California, United States
Clinical Science Institute Clinical Research Specialists Inc
Santa Monica, California, United States
Cura Clinical Research
Sherman Oaks, California, United States
Sutter Health Palo Alto Medical Foundation Pamf Sunnyvale Center
Sunnyvale, California, United States
Renaissance Research
Cape Coral, Florida, United States
Encore Medical Research, Llc
Hollywood, Florida, United States
Savin Medical Group, Rc
Miami, Florida, United States
Skin Research of South Florida, Llc
Miami, Florida, United States
San Marcus Research Clinic Inc.
Miami Lakes, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
Forcare Clinical Research
Tampa, Florida, United States
Cleaver Medical Group
Cumming, Georgia, United States
Dermatology and Surgery Specialists of North Atlanta
Marietta, Georgia, United States
Pivotal Research Solutions
Stonecrest, Georgia, United States
Options Research Group, Llc
Kokomo, Indiana, United States
Allcutis Research, Llc
Beverly, Massachusetts, United States
Metro Boston Clinical Partners
Brighton, Massachusetts, United States
Great Lakes Research Group Inc
Bay City, Michigan, United States
Wayne State University Physician Group Dermatology
Dearborn, Michigan, United States
Revival Research Institute, Llc Dermatology
Troy, Michigan, United States
Medisearch Clinical Trials
Saint Joseph, Missouri, United States
Jdr Dermatology Research
Las Vegas, Nevada, United States
Empire Dermatology
East Syracuse, New York, United States
Sadick Dermatology Sadick Research Group
New York, New York, United States
Derm Research Center of New York Inc
Stony Brook, New York, United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee, United States
University of Texas Physicians - Bellaire Station
Bellaire, Texas, United States
Center For Clinical Studies
Houston, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Jordan Valley Dermatology Center
West Jordan, Utah, United States
Clinical Research Partners Llc Crp Richmond Forest Avenue Office Building Location
Richmond, Virginia, United States
Dermatology Specialists of Spokane
Spokane, Washington, United States
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel
Brussel/ Brussels/bruxelles, , Belgium
Universitair Ziekenhuis Gent (Uz Gent)
Ghent, , Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, , Belgium
Cliniques Universitaires Ucl Saint-Luc
Woluwe-Saint-Lambert, , Belgium
Dermatology Research Institute
Calgary, Alberta, Canada
Enverus Medical Research
Surrey, British Columbia, Canada
Leader Research
Burlington, Ontario, Canada
Dermeffects
London, Ontario, Canada
North York Research Inc.
North YORK, Ontario, Canada
Care Clinic
Ottawa, Ontario, Canada
Siena Medical Research Corporation
Ottawa, Ontario, Canada
Skin Health
Peterborough, Ontario, Canada
Alliance Clinical Trials
Waterloo, Ontario, Canada
Centre Hospitalier Universitaire (Chu) - Hopital Henri Mondor
Bordeaux, , France
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
Bordeaux, , France
Clinique de Courlancy
Reims, , France
Hopital Larrey
Toulouse, , France
Universitatsklinikum Erlangen
Erlangen, , Germany
Klinikum Der Johann Wolfgang Goethe University
Frankfurt am Main, , Germany
Derma-Study-Center Friedrichshafen Gmbh
Friedrichshafen, , Germany
Dermatologische Gemeinschaftspraxis Dres. Quist
Mainz, , Germany
Beldio Research Gmbh
Memmingen, , Germany
Hamamatsu University Hospital
Hamamatsu, , Japan
St. Marianna University School of Medicine Hospital
Kawasaki, , Japan
Kobe University Hospital
Kobe, , Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, , Japan
Dokkyo Medical University Saitama Medical Center
Minamikoshigaya, , Japan
Nagasaki University Hospital
Nagasaki, , Japan
Nagoya City University Hospital
Nagoya, , Japan
Kochi Medical School Hospital
Nankoku, , Japan
Niigata University Medical and Dental Hospital
Niigata, , Japan
National Hospital Organization Okayama Medical Center
Okayama, , Japan
Tohoku University Hospital
Sendai, , Japan
Ntt Medical Center Tokyo
Shinagawa-ku, , Japan
Tokyo Medical University Hospital
Shinjuku-ku, , Japan
Osaka University Hospital
Suita, , Japan
National University Corporation - Tokyo Medical and Dental University (Tmdu)
Tokyo, , Japan
Juntendo University Urayasu Hospital
Urayasu, , Japan
Yamagata University Hospital
Yamagata, , Japan
Trials in Medicine S.C.
Deleg. Cuauhtemoc, , Mexico
Instituto de Investigaciones Aplicadas A La Neurociencia A.C
Durango, , Mexico
Centro de Dermatologia de Monterrey
Monterrey, , Mexico
Universidad Autonoma de Nuevo Leon (Uanl) - Hospital Universitario Dr. Jose Eleuterio Gonzalez - Cen
Monterrey, , Mexico
Clinica de Enfermedades Cronicas Y de Procedimientos Especiales (Cecype)
Morelia, , Mexico
Grupo Clínico Catei Sc
Providencia 5TA Seccion, , Mexico
Uva - Amc - Stichting Nederlands Instituut Voor Pigmentstoornissen (Snip) (Netherlands Institute For
Amsterdam, , Netherlands
Bravis Ziekenhuis
Bergen op Zoom, , Netherlands
Dermapolis Medical Dermatology Center Dr N. Med. Edyta Gebska
Chorzów, , Poland
Synexus Polska Sp Z Oo Oddzial W Czestochowie
Częstochowa, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Synexus Polska Sp. Z O.O. Oddzial W Katowicach
Katowice, , Poland
Synexus Polska Sp Z Oo Oddzial W Lodzi
Lodz, , Poland
Dermodent Centrum Medyczne Aldona Czajkowska Rafa¿ Czajkowski
Osielsko, , Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, , Poland
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Rzeszów, , Poland
Panstwowy Instytut Medyczny Mswia
Warsaw, , Poland
Carpe Diem Centrum Medycyny Estetycznej
Warsaw, , Poland
Synexus Polska Sp. Z O.O. Oddzial W Warszawie
Warsaw, , Poland
Etg Warszawa
Warsaw, , Poland
Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia
Wrocaw, , Poland
Hospital Universitario Fundacion Alcorcon
Alcorcón, , Spain
Hospital Universitari Germans Trias I Pujol (Hugtp)
Badalona, , Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Clinica Universidad de Navarra (Cun)
Madrid, , Spain
Hospital de Manises
Manises, , Spain
Countries
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Related Links
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A study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)
Other Identifiers
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2023-505782-86-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCB54707-303
Identifier Type: -
Identifier Source: org_study_id
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