A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)

Last updated: December 19, 2024
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

3

Condition

Vitiligo

Treatment

Placebo

Povorcitinib

Clinical Study ID

NCT06113445
INCB54707-303
2023-505782-86-00
  • 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: 444
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 29, 2023
Estimated Completion Date:
May 08, 2027

Connect with a study center

  • Hopital Universitaire de Bruxelles (H.U.B)/ Academisch Ziekenhuis Brussel

    Brussel/ Brussels/bruxelles, 01070
    Belgium

    Site Not Available

  • Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel

    Brussel/ Brussels/bruxelles, 01070
    Belgium

    Active - Recruiting

  • Hopital Universitaire de Bruxelles (H.U.B)/ Academisch Ziekenhuis Brussel

    Brussels, 01070
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 09000
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent (Uz Gent)

    Gent, 09000
    Belgium

    Active - Recruiting

  • Centre Hospitalier Universitaire (Chu) de Liege - Domaine Universitaire Du Sart Tilman

    Liege, 04000
    Belgium

    Active - Recruiting

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liege, 04000
    Belgium

    Active - Recruiting

  • Cliniques Universitaires Ucl Saint-Luc

    Woluwe-saint-lambert, 01200
    Belgium

    Active - Recruiting

  • Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc

    Woluwe-saint-lambert, 01200
    Belgium

    Active - Recruiting

  • Dermatology Research Institute

    Calgary, Alberta T2J 7E1
    Canada

    Active - Recruiting

  • Dr. Chih-Ho Hong Medical Inc.

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Enverus Medical Research

    Surrey, British Columbia V3V 0C6
    Canada

    Active - Recruiting

  • Leader Research

    Burlington, Ontario L7R 4H9
    Canada

    Active - Recruiting

  • Dermeffects

    London, Ontario N6H 5L5
    Canada

    Active - Recruiting

  • North York Research Inc.

    North York, Ontario M2M 4J5
    Canada

    Active - Recruiting

  • Care Clinic

    Ottawa, Ontario K1A 0K9
    Canada

    Site Not Available

  • Siena Medical Research Corporation

    Ottawa, Ontario K1A 0K9
    Canada

    Completed

  • Skin Health

    Peterborough, Ontario K9J 5K2
    Canada

    Active - Recruiting

  • Alliance Clinical Trials

    Waterloo, Ontario N2J 1C4
    Canada

    Active - Recruiting

  • Bordeaux Chu Hopital Saint - Andre

    Bordeaux Cedex, 33075
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire (Chu) - Hopital Henri Mondor

    Bordeaux Cedex, 33075
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre

    Bordeaux Cedex, 33075
    France

    Active - Recruiting

  • Clinique de Courlancy

    Reims, 51100
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire (Chu)

    Toulouse, 31059
    France

    Active - Recruiting

  • Hopital Larrey

    Toulouse, 31059
    France

    Active - Recruiting

  • Universitatsklinikum Erlangen

    Erlangen, 91054
    Germany

    Active - Recruiting

  • Universitatsklinikum Erlangen Hautklinik

    Erlangen, 91054
    Germany

    Site Not Available

  • Klinikum Der Johann Wolfgang Goethe University

    Frankfurt Am Main, 60590
    Germany

    Active - Recruiting

  • Klinikum Der Johann Wolfgang Goethe-Universitaet Frankfurt

    Frankfurt Am Main, 60590
    Germany

    Active - Recruiting

  • Derma-Study-Center Friedrichshafen Gmbh

    Friedrichshafen, 88045
    Germany

    Active - Recruiting

  • Dermatologische Gemeinschaftspraxis Dres. Quist

    Mainz, 55128
    Germany

    Active - Recruiting

  • Beldio Research Gmbh

    Memmingen, 87700
    Germany

    Active - Recruiting

  • Beldio Research Gmbh, Dr. Schwinn,

    Memmingen, 87700
    Germany

    Active - Recruiting

  • Hamamatsu University Hospital

    Hamamatsu, 431-3192
    Japan

    Active - Recruiting

  • St. Marianna University School of Medicine Hospital

    Kawasaki, 216-8511
    Japan

    Active - Recruiting

  • Kobe University Hospital

    Kobe, 6500017
    Japan

    Active - Recruiting

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566
    Japan

    Active - Recruiting

  • Dokkyo Medical University Saitama Medical Center

    Minamikoshigaya, 343-8555
    Japan

    Active - Recruiting

  • Nagasaki University Hospital

    Nagasaki-shi, 852-8501
    Japan

    Active - Recruiting

  • Nagoya City University Hospital

    Nagoya, 467-8602
    Japan

    Active - Recruiting

  • Kochi Medical School Hospital

    Nankoku, 783-8505
    Japan

    Active - Recruiting

  • Niigata University Medical and Dental Hospital

    Niigata, 9518520
    Japan

    Active - Recruiting

  • National Hospital Organization Okayama Medical Center

    Okayama-shi, 701-1192
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai, 980-8574
    Japan

    Active - Recruiting

  • Ntt Medical Center Tokyo

    Shinagawa-ku, 141-8625
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-ku, 160-0023
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Suita, 565-0871
    Japan

    Active - Recruiting

  • National University Corporation - Tokyo Medical and Dental University (Tmdu)

    Tokyo, 113-8519
    Japan

    Active - Recruiting

  • Juntendo University Urayasu Hospital

    Urayasu, 279-0021
    Japan

    Active - Recruiting

  • Yamagata University Hospital

    Yamagata-shi, 990-9585
    Japan

    Active - Recruiting

  • Trials in Medicine S.C.

    Cuauhtemoc, 06700
    Mexico

    Site Not Available

  • Trials in Medicine S.C.

    Deleg. Cuauhtemoc, 06700
    Mexico

    Completed

  • Instituto de Investigaciones Aplicadas A La Neurociencia A.C

    Durango, 34000
    Mexico

    Completed

  • Grupo Clínico Catei Sc

    Guadalajara, 44600
    Mexico

    Site Not Available

  • Centro de Dermatologia de Monterrey

    Monterrey, 64460
    Mexico

    Completed

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, 64660
    Mexico

    Site Not Available

  • Universidad Autonoma de Nuevo Leon (Uanl) - Hospital Universitario Dr. Jose Eleuterio Gonzalez - Cen

    Monterrey, 64660
    Mexico

    Completed

  • Clinica de Enfermedades Cronicas Y de Procedimientos Especiales (Cecype)

    Morelia, 58249
    Mexico

    Completed

  • Grupo Clínico Catei Sc

    Providencia 5TA Seccion,
    Mexico

    Active - Recruiting

  • Uva - Amc - Stichting Nederlands Instituut Voor Pigmentstoornissen (Snip) (Netherlands Institute For

    Amsterdam, 1105 AZ
    Netherlands

    Active - Recruiting

  • Bravis Ziekenhuis

    Bergen Op Zoom, 4624 VT
    Netherlands

    Active - Recruiting

  • Dermapolis Medical Dermatology Center Dr N. Med. Edyta Gebska

    Chorzow, 41-516
    Poland

    Active - Recruiting

  • Synexus Polska Sp Z Oo Oddzial W Czestochowie

    Czestochowa, 42-202
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214
    Poland

    Completed

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

    Katowice, 40-040
    Poland

    Site Not Available

  • Synexus Polska Sp Z Oo Oddzial W Lodzi

    Lodz, 90-127
    Poland

    Site Not Available

  • Dermodent Centrum Medyczne Aldona Czajkowska Rafa¿ Czajkowski

    Osielsko, 86-031
    Poland

    Active - Recruiting

  • Dermedic Jacek Zdybski

    Ostrowiec Swietokrzyski, 27-400
    Poland

    Active - Recruiting

  • Prywatny Gabinet Dermatologiczny

    Ostrowiec Swietokrzyski, 27-400
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie

    Rzeszow, 35-055
    Poland

    Site Not Available

  • Etg Warszawa

    Warsaw, 02-777
    Poland

    Active - Recruiting

  • Carpe Diem Centrum Medycyny Estetycznej

    Warszawa, 02-661
    Poland

    Active - Recruiting

  • Csk Mswia Centralny Szpital Kliniczny Mswia

    Warszawa, 02-507
    Poland

    Active - Recruiting

  • Panstwowy Instytut Medyczny Mswia

    Warszawa, 02-507
    Poland

    Active - Recruiting

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

    Warszawa, 02-672
    Poland

    Active - Recruiting

  • Synexus Polska Sp. Z O.O. Oddzial Warszawie

    Warszawa, 02-672
    Poland

    Active - Recruiting

  • Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia

    Wrocaw, 54144
    Poland

    Active - Recruiting

  • Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia

    Wroclaw, 54144
    Poland

    Site Not Available

  • Hospital Universitario Fundacion Alcorcon

    Alcorcon, 28922
    Spain

    Active - Recruiting

  • *Germans Trias I Pujol

    Badalona, 08916
    Spain

    Site Not Available

  • Germans Trias I Pujol

    Badalona, 08916
    Spain

    Site Not Available

  • Hospital Universitari Germans Trias I Pujol (Hugtp)

    Badalona, 08916
    Spain

    Active - Recruiting

  • Hospital Universitario Germans Trias I Pujol

    Badalona, 08916
    Spain

    Active - Recruiting

  • Hospital Clinic I Provincial

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Clinica Universidad Navarra-Sede Madrid

    Madrid, 31008
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra (Cun)

    Madrid, 31008
    Spain

    Active - Recruiting

  • Clinical Universidad de Navarra Madrid

    Madrid, 31008
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital de Manises

    Manises, 46940
    Spain

    Active - Recruiting

  • Cahaba Dermatology

    Hoover, Alabama 35244
    United States

    Active - Recruiting

  • University of California Irvine

    Irvine, California 92697
    United States

    Active - Recruiting

  • Clinical Science Institute Clinical Research Specialists Inc

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Cura Clinical Research

    Sherman Oaks, California 91403
    United States

    Active - Recruiting

  • Sutter Health Palo Alto Medical Foundation Pamf Sunnyvale Center

    Sunnyvale, California 94086
    United States

    Active - Recruiting

  • Renaissance Research

    Cape Coral, Florida 33991
    United States

    Active - Recruiting

  • Encore Medical Research, Llc

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Encore Medical Research, Llc Hollywood

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Savin Medical Group, Rc

    Miami, Florida 33156
    United States

    Active - Recruiting

  • Skin Research of South Florida, Llc

    Miami, Florida 33173
    United States

    Active - Recruiting

  • San Marcus Research Clinic Inc.

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Forcare Clinical Research

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Olympian Clinical Research

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • Cleaver Medical Group

    Cumming, Georgia 30040
    United States

    Active - Recruiting

  • Dermatology and Surgery Specialists of North Atlanta

    Marietta, Georgia 30068
    United States

    Completed

  • Pivotal Research Solutions

    Stonecrest, Georgia 30038
    United States

    Active - Recruiting

  • Options Research Group, Llc

    Kokomo, Indiana 46901
    United States

    Active - Recruiting

  • Randall Dermatology

    Kokomo, Indiana 46901
    United States

    Active - Recruiting

  • Allcutis Research Inc Beverly

    Beverly, Massachusetts 01915
    United States

    Completed

  • Allcutis Research, Llc

    Beverly, Massachusetts 01915
    United States

    Completed

  • Metro Boston Clinical Partners

    Brighton, Massachusetts 02135-3511
    United States

    Active - Recruiting

  • Great Lakes Research Group Inc

    Bay City, Michigan 48706
    United States

    Completed

  • Wayne State University Physician Group Dermatology

    Dearborn, Michigan 48124
    United States

    Active - Recruiting

  • Revival Research Institute, Llc Dermatology

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • Grekin Skin Institute Warren

    Warren, Michigan 48088
    United States

    Site Not Available

  • Medisearch Clinical Trials

    Saint Joseph, Missouri 64506
    United States

    Active - Recruiting

  • Jdr Dermatology Research

    Las Vegas, Nevada 89148
    United States

    Active - Recruiting

  • Schweiger Dermatology Group - Verona

    Verona, New Jersey 07044
    United States

    Site Not Available

  • Empire Dermatology

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • Mount Sinai Medical Center

    New York, New York 10029
    United States

    Site Not Available

  • Sadick Dermatology Sadick Research Group

    New York, New York 10075
    United States

    Active - Recruiting

  • Derm Research Center of New York Inc

    Stony Brook, New York 11790
    United States

    Completed

  • Bexley Dermatology

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Dermatology Associates of Plymouth Meeting

    Plymouth Meeting, Pennsylvania 19462
    United States

    Active - Recruiting

  • International Clinical Research Tennessee Llc

    Murfreesboro, Tennessee 37130
    United States

    Active - Recruiting

  • University of Texas Physicians - Bellaire Station

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Center For Clinical Studies

    Houston, Texas 77004
    United States

    Active - Recruiting

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Active - Recruiting

  • Jordan Valley Dermatology Center

    West Jordan, Utah 84088
    United States

    Active - Recruiting

  • Clinical Research Partners Llc Crp Richmond Forest Avenue Office Building Location

    Richmond, Virginia 23226
    United States

    Active - Recruiting

  • Dermatology Specialists of Spokane

    Spokane, Washington 99202
    United States

    Completed

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