A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2)
NCT ID: NCT06113471
Last Updated: 2026-02-03
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
450 participants
INTERVENTIONAL
2023-11-27
2027-03-16
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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University of Alabama At Birmingham Hospital-Whitaker Clinic
Birmingham, Alabama, United States
C2 Research Center, Llc
Montgomery, Alabama, United States
First Oc Dermatology Research Inc
Fountain Valley, California, United States
Center For Dermatology Clinical Research, Inc
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
Clinical Trials Research Institute
Thousand Oaks, California, United States
Skin Care Research, Llc
Boca Raton, Florida, United States
Total Vein and Skin Llc
Boynton Beach, Florida, United States
Driven Research Llc
Coral Gables, Florida, United States
Florida Academic Centers Research and Education Llc
Coral Gables, Florida, United States
Pediatric Skin Research Llc
Coral Gables, Florida, United States
Metabolic Research Institute Inc
West Palm Beach, Florida, United States
Dermatology and Surgery Specialists of North Atlanta
Marietta, Georgia, United States
Advanced Medical Research Pc
Sandy Springs, Georgia, United States
Dundee Dermatology
West Dundee, Illinois, United States
Indiana University School of Medicine Iusm Indianapolis
Indianapolis, Indiana, United States
Delricht Research
Baton Rouge, Louisiana, United States
Callender Dermatology and Cosmetic Center
Glenn Dale, Maryland, United States
Aesthetic and Dermatology Center
Rockville, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Allcutis Research, Llc
Portsmouth, New Hampshire, United States
Weill Cornell Medical College
New York, New York, United States
Remington-Davis Clinical Research
Columbus, Ohio, United States
Oregon Medical Research Center, Pc
Portland, Oregon, United States
Dermatology Treatment and Research Center
Dallas, Texas, United States
Heights Dermatology and Aesthetic Center
Houston, Texas, United States
University of Texas, Md Anderson Cancer
Houston, Texas, United States
Innovative Dermatology: Legacy Medical Village
Plano, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Premier Clinical Research
Spokane, Washington, United States
Medical Center Asklepii Ood
Dupnitsa, , Bulgaria
Medical Center Unimed Eood
Sliven, , Bulgaria
Ambulatory For Specialized Medical Care - Individual Practice For Specialized Medical Care - Skin An
Sofia, , Bulgaria
Aleksandrovska University Hospital
Sofia, , Bulgaria
28 Diagnostic and Consultative Center
Sofia, , Bulgaria
British Columbia'S Centre For Dermatologic Science - the Skin Care Centre
Vancouver, British Columbia, Canada
Lynderm Research Inc
Markham, Ontario, Canada
DERMEDGE
Mississauga, Ontario, Canada
Toronto Research Centre
Toronto, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
Centre de Recherche Dermatologique de Quebec
Québec, Quebec, Canada
Chru Morvan/Chu Brest Hopital Morvan
Brest, , France
Centre Hospitalier - Le Mans
Le Mans, , France
Cabinet Medical- Chemin de Paradis
Martigues, , France
Centre Hospitalier Universitaire de Nice,Hopital L Archet
Nice, , France
Hopital Charles Nicolle
Rouen, , France
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, , Germany
University Hospital Carl Gustav Carus
Dresden, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Dermatologische Gemeinschaftspraxis
Mahlow, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Orvostudomanyi Kutato Es Fejleszto Kft
Debrecen, , Hungary
Debreceni Egyetem
Debrecen, , Hungary
Markusovszky Teaching Hospital
Szombathely, , Hungary
Asst Degli Spedali Civili Di Brescia
Brescia, , Italy
Azienda Policlinico Vittorio Emanuele
Catania, , Italy
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, , Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Rome, , Italy
Irccs Istituto Clinico Humanitas
Rozzano, , Italy
Synexus Polska Sp. Z O.O. Oddzial W Gdansku
Gdansk, , Poland
Synexus Gdynia
Gdynia, , Poland
Provita Sp.Zo.O. Centrum Medyczne Angelius
Katowice, , Poland
Pro Familia Altera Sp. Z O.O.
Katowice, , Poland
Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
Kielce, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej Dermed Centrum Medyczne Sp. Z O.O.
Lodz, , Poland
Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak
Lodz, , Poland
Velocity Clinical Research, Skierniewice
Skierniewice, , Poland
Laser Clinic
Szczecin, , Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, , Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z O.O.
Tarnów, , Poland
Centrum Medyczne Evimed
Warsaw, , Poland
Royalderm Agnieszka Nawrocka
Warsaw, , Poland
Klinika Ambroziak Sp. Z O.O.
Warsaw, , Poland
Futuremeds Targowek Centrum Medyczne Amed Warszawa Targowek
Wrocaw, , Poland
Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu
Wroclaw, , Poland
Dermmedica Sp. Z O.O.
Wroclaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust
Ipswich, , United Kingdom
University Hospitals of Leicester-Leicester Royal Infirmary (Lri)
Leicester, , United Kingdom
Whipps Cross University Hospital - Barts Health Nhs Trust
London, , United Kingdom
Nottingham University Hospitals - Treatment Center
Nottingham, , United Kingdom
Royal Wolverhampton Nhs Trust
Walsall, , United Kingdom
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-V2)
Other Identifiers
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2023-506011-18-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCB54707-304
Identifier Type: -
Identifier Source: org_study_id
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