A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2)

Last updated: March 19, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Not Recruiting

Phase

3

Condition

Vitiligo

Treatment

Povorcitinib

Placebo

Clinical Study ID

NCT06113471
INCB54707-304
2023-506011-18-00
  • Ages > 18
  • All Genders

Study Summary

This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged ≥ 18 years.

  • 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 fromscreening through the final safety follow-up visit.

  • Willingness to avoid pregnancy or fathering children.

Exclusion

Exclusion Criteria:

  • Other forms of vitiligo or skin depigmentation disorders.

  • Clinically significant abnormal TSH or free T4 at screening.

  • Use of laser or phototherapy within 8 weeks and dihydroxyacetone within 4 weeksprior to Day 1.

  • Current or past use of the depigmenting agent monobenzyl ether of hydroquinoneincluding Benoquin®.

  • History of melanocyte-keratinocyte transplantation procedure or other surgicaltreatment 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; disseminatedherpes 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.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Design

Total Participants: 450
Treatment Group(s): 2
Primary Treatment: Povorcitinib
Phase: 3
Study Start date:
November 27, 2023
Estimated Completion Date:
May 17, 2027

Connect with a study center

  • Medical Center Asklepii Ood

    Dupnitsa, 02600
    Bulgaria

    Site Not Available

  • Mc Unimed

    Sliven, 05308
    Bulgaria

    Active - Recruiting

  • Medical Center Unimed Eood

    Sliven, 05308
    Bulgaria

    Site Not Available

  • 28 Diagnostic and Consultative Center

    Sofia, 01528
    Bulgaria

    Site Not Available

  • Aleksandrovska University Hospital

    Sofia, 01431
    Bulgaria

    Site Not Available

  • Ambulatory For Specialized Medical Care - Individual Practice For Specialized Medical Care - Skin An

    Sofia, 01407
    Bulgaria

    Site Not Available

  • British Columbia'S Centre For Dermatologic Science - the Skin Care Centre

    Vancouver, British Columbia V5Z 4E8
    Canada

    Site Not Available

  • Lynderm Research Inc

    Markham, Ontario L3P 1X2
    Canada

    Site Not Available

  • DERMEDGE

    Mississauga, Ontario L4Y 4C5
    Canada

    Site Not Available

  • Research Toronto

    Toronto, Ontario M4W 2N4
    Canada

    Site Not Available

  • Toronto Research Centre

    Toronto, Ontario M3H 5Y8
    Canada

    Site Not Available

  • Centre de Recherche Dermatologique de Quebec

    Quebec City, Quebec G1V4X7
    Canada

    Site Not Available

  • Chru Morvan/Chu Brest Hopital Morvan

    Brest, 29200
    France

    Site Not Available

  • Centre Hospitalier - Le Mans

    Le Mans, 72037
    France

    Site Not Available

  • Hopital Edouard Herrio

    Lyon Cedex 03, 69003
    France

    Site Not Available

  • Hospices Civils de Lyon (Hcl) - Hopital Edouard Herriot (Heh)

    Lyon Cedex 03, 69003
    France

    Site Not Available

  • Cabinet Medical- Chemin de Paradis

    Martigues, 13500
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nice,Hopital L Archet

    Nice, 06200
    France

    Site Not Available

  • Hopital Charles Nicolle

    Rouen Cedex, 76031
    France

    Site Not Available

  • Fachklinik Bad Bentheim

    Bad Bentheim, 481455
    Germany

    Site Not Available

  • Fachklinik Bad Bentheim Dermatologie

    Bad Bentheim, 481455
    Germany

    Site Not Available

  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte

    Berlin, 10117
    Germany

    Site Not Available

  • University Hospital Carl Gustav Carus

    Dresden, 01307
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • Universitatsklinikum Hamburg

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Dermatologische Gemeinschaftspraxis

    Mahlow, 15831
    Germany

    Site Not Available

  • Universitaetsklinikum Muenster

    Muenster, 48149
    Germany

    Site Not Available

  • Universitatsklinikum Munster

    Muenster, 48149
    Germany

    Site Not Available

  • Clinexpert

    Budapest, 01033
    Hungary

    Site Not Available

  • Clinexpert Egeszsegugyi Szolgaltato Es Kereskedelmi Kft.

    Budapest, 01033
    Hungary

    Site Not Available

  • Debreceni Egyetem

    Debrecen, 04032
    Hungary

    Site Not Available

  • Orvostudomanyi Kutato Es Fejleszto Kft

    Debrecen, 04027
    Hungary

    Site Not Available

  • Obudai Egeszsegugyi Centrum - Dunaujvaros

    Dunaujvaros, H-2400
    Hungary

    Site Not Available

  • Markusovszky Teaching Hospital

    Szombathely,
    Hungary

    Site Not Available

  • Asst Degli Spedali Civili Di Brescia

    Brescia, 25123
    Italy

    Site Not Available

  • Azienda Ospedaliera Spedali Civili Di Brescia-Universita Degli Studi Di Brescia

    Brescia, 25123
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele Ospedale Gaspare Rodolico Di Catania

    Catania, 95123
    Italy

    Site Not Available

  • Azienda Policlinico Vittorio Emanuele

    Catania, 95123
    Italy

    Site Not Available

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milano, 20122
    Italy

    Site Not Available

  • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs

    Rome, 00168
    Italy

    Site Not Available

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Synexus - Polska Sp Z Oo Oddzial W Gdansk

    Gdansk, 80-382
    Poland

    Site Not Available

  • Synexus - Polska Sp Z Oo Oddzial W Gdansksynexus Affiliate - Bialystok - Clinicmed Daniluk Nowak Spo

    Gdansk, 80-382
    Poland

    Site Not Available

  • Synexus Polska Sp. Z O.O. Oddzial W Gdansku

    Gdansk, 80-382
    Poland

    Site Not Available

  • Synexus Gdynia

    Gdynia, 81-537
    Poland

    Site Not Available

  • Pro Familia Altera Sp. Z O.O.

    Katowice, 40-648
    Poland

    Site Not Available

  • Provita Sp.Zo.O. Centrum Medyczne Angelius

    Katowice, 40-611
    Poland

    Site Not Available

  • Prywatny Gabinet Dermatologiczny Elzbieta Klujszo

    Kielce, 25-316
    Poland

    Site Not Available

  • Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak

    Lodz, 90-436
    Poland

    Site Not Available

  • Niepubliczny Zaklad Opieki Zdrowotnej Dermed Centrum Medyczne Sp. Z O.O.

    Lodz, 90-265
    Poland

    Site Not Available

  • Etg Skierniewice

    Skierniewice, 96-100
    Poland

    Site Not Available

  • Velocity Clinical Research, Skierniewice

    Skierniewice, 96-100
    Poland

    Site Not Available

  • Laser Clinic

    Szczecin, 70-332
    Poland

    Site Not Available

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434
    Poland

    Site Not Available

  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z O.O.

    Tarnow, 33-100
    Poland

    Site Not Available

  • Centrum Medyczne Evimed

    Warsaw, 02-625
    Poland

    Site Not Available

  • Futuremeds Targowek Centrum Medyczne Amed Warszawa Targowek

    Warszawa, 03-291
    Poland

    Site Not Available

  • Klinika Ambroziak Sp. Z O.O.

    Warszawa, 02-953
    Poland

    Site Not Available

  • Royalderm Agnieszka Nawrocka

    Warszawa, 02-692
    Poland

    Site Not Available

  • Futuremeds Targowek Centrum Medyczne Amed Warszawa Targowek

    Wrocaw, 03-291
    Poland

    Site Not Available

  • Centrum Medyczne Oporow

    Wroclaw, 52-416
    Poland

    Site Not Available

  • Dermmedica Sp. Z O.O.

    Wroclaw, 51-318
    Poland

    Site Not Available

  • Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu

    Wroclaw, 50-088
    Poland

    Site Not Available

  • Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust

    Ipswich, IP4 5PD
    United Kingdom

    Site Not Available

  • University Hospitals of Leicester-Leicester Royal Infirmary (Lri)

    Leicester, LE1 5WW
    United Kingdom

    Site Not Available

  • Barts Health Nhs Trust - Whipps Cross University Hospital

    London, E11 1NR
    United Kingdom

    Site Not Available

  • Whipps Cross University Hospital - Barts Health Nhs Trust

    London, E11 1NR
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals - Treatment Center

    Nottingham, NG7 2FT
    United Kingdom

    Site Not Available

  • Manor Hospital (Walsall) - Walsall Healthcare Nhs Trust

    Walsall, WS2 9PS
    United Kingdom

    Site Not Available

  • Royal Wolverhampton Nhs Trust

    Walsall, WS2 9PS
    United Kingdom

    Site Not Available

  • University of Alabama At Birmingham Hospital-Whitaker Clinic

    Birmingham, Alabama 35294-0007
    United States

    Site Not Available

  • C2 Research Center, Llc

    Montgomery, Alabama 36117
    United States

    Site Not Available

  • First Oc Dermatology Research Inc

    Fountain Valley, California 92708-3701
    United States

    Site Not Available

  • Tien Q Nguyen Md Inc

    Fountain Valley, California 92708-3701
    United States

    Active - Recruiting

  • Center For Dermatology Clinical Research, Inc

    Fremont, California 94538
    United States

    Site Not Available

  • Marvel Clinical Research Llc

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • Vitiligo & Pigmentation Institute of Southern California

    Los Angeles, California 90036-5609
    United States

    Site Not Available

  • Clinical Trials Research Institute

    Thousand Oaks, California 91320
    United States

    Site Not Available

  • Skin Care Research, Llc

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Total Vein and Skin Llc

    Boynton Beach, Florida 33437
    United States

    Site Not Available

  • Driven Research Llc

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Florida Academic Centers Research and Education Llc

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Pediatric Skin Research Llc

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • Metabolic Research Institute Inc

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Dermatology and Surgery Specialists of North Atlanta

    Marietta, Georgia 30068
    United States

    Site Not Available

  • Advanced Medical Research Pc

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Dundee Dermatology

    West Dundee, Illinois 60118
    United States

    Site Not Available

  • Indiana University School of Medicine Iusm Indianapolis

    Indianapolis, Indiana 46202-3082
    United States

    Site Not Available

  • Delricht Research

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Callender Dermatology and Cosmetic Center

    Glenn Dale, Maryland 20769
    United States

    Site Not Available

  • Aesthetic and Dermatology Center

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Hamzavi Dermatology

    Fort Gratiot, Michigan 48059
    United States

    Site Not Available

  • Allcutis Research, Inc Portsmouth

    Portsmouth, New Hampshire 03801
    United States

    Active - Recruiting

  • Allcutis Research, Llc

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Dr Bobby Buka, Md Greenwich Village

    New York, New York 10012
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York 10065
    United States

    Site Not Available

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Site Not Available

  • Accellacare Wilmington

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Remington-Davis Clinical Research

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Oregon Medical Research Center

    Portland, Oregon 97223
    United States

    Site Not Available

  • Oregon Medical Research Center, Pc

    Portland, Oregon 97223
    United States

    Site Not Available

  • Kgl Skin Study Center

    Newtown Square, Pennsylvania 19073
    United States

    Site Not Available

  • Health Concepts Rapid City

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • Dermatology Treatment and Research Center

    Dallas, Texas 75230
    United States

    Site Not Available

  • Heights Dermatology and Aesthetic Center

    Houston, Texas 77008
    United States

    Site Not Available

  • University of Texas, Md Anderson Cancer

    Houston, Texas 77030
    United States

    Site Not Available

  • Austin Institute For Clinical Research Aicr Pflugerville

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Innovative Dermatology: Legacy Medical Village

    Plano, Texas 75024
    United States

    Site Not Available

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas 78218
    United States

    Site Not Available

  • Complete Dermatology

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Premier Clinical Research

    Spokane, Washington 99202
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.