A Phase 3, Randomized, Double-Blind, 52-Week, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Nonsegmental Vitiligo
Status: Active_not_recruiting
Location: See all (100) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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 from screening through the final safety follow-up visit.
• Willingness to avoid pregnancy or fathering children.
Locations
United States
Alabama
Cahaba Dermatology
Hoover
California
University of California Irvine
Irvine
Clinical Science Institute Clinical Research Specialists Inc
Santa Monica
Cura Clinical Research
Sherman Oaks
Sutter Health Palo Alto Medical Foundation Pamf Sunnyvale Center
Sunnyvale
Florida
Renaissance Research
Cape Coral
Encore Medical Research, Llc
Hollywood
Savin Medical Group, Rc
Miami
Skin Research of South Florida, Llc
Miami
San Marcus Research Clinic Inc.
Miami Lakes
Forcare Clinical Research
Tampa
Olympian Clinical Research
Tampa
Georgia
Cleaver Medical Group
Cumming
Dermatology and Surgery Specialists of North Atlanta
Marietta
Pivotal Research Solutions
Stonecrest
Indiana
Options Research Group, Llc
Kokomo
Massachusetts
Allcutis Research, Llc
Beverly
Metro Boston Clinical Partners
Brighton
Michigan
Great Lakes Research Group Inc
Bay City
Wayne State University Physician Group Dermatology
Dearborn
Revival Research Institute, Llc Dermatology
Troy
Missouri
Medisearch Clinical Trials
Saint Joseph
Nevada
Jdr Dermatology Research
Las Vegas
New York
Empire Dermatology
East Syracuse
Sadick Dermatology Sadick Research Group
New York
Derm Research Center of New York Inc
Stony Brook
Pennsylvania
Dermatology Associates of Plymouth Meeting
Plymouth Meeting
Tennessee
International Clinical Research Tennessee Llc
Murfreesboro
Texas
University of Texas Physicians - Bellaire Station
Bellaire
Center For Clinical Studies
Houston
Progressive Clinical Research
San Antonio
Utah
Jordan Valley Dermatology Center
West Jordan
Virginia
Clinical Research Partners Llc Crp Richmond Forest Avenue Office Building Location
Richmond
Washington
Dermatology Specialists of Spokane
Spokane
Other Locations
Belgium
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel
Brussel/ Brussels/bruxelles
Universitair Ziekenhuis Gent (Uz Gent)
Ghent
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège
Cliniques Universitaires Ucl Saint-Luc
Woluwe-saint-lambert
Canada
Leader Research
Burlington
Dermatology Research Institute
Calgary
Dermeffects
London
North York Research Inc.
North York
Care Clinic
Ottawa
Siena Medical Research Corporation
Ottawa
Skin Health
Peterborough
Enverus Medical Research
Surrey
Alliance Clinical Trials
Waterloo
France
Centre Hospitalier Universitaire (Chu) - Hopital Henri Mondor
Bordeaux
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
Bordeaux
Clinique de Courlancy
Reims
Hopital Larrey
Toulouse
Germany
Universitatsklinikum Erlangen
Erlangen
Klinikum Der Johann Wolfgang Goethe University
Frankfurt Am Main
Derma-Study-Center Friedrichshafen Gmbh
Friedrichshafen
Dermatologische Gemeinschaftspraxis Dres. Quist
Mainz
Beldio Research Gmbh
Memmingen
Japan
Hamamatsu University Hospital
Hamamatsu
St. Marianna University School of Medicine Hospital
Kawasaki
Kobe University Hospital
Kobe
University Hospital Kyoto Prefectural University of Medicine
Kyoto
Dokkyo Medical University Saitama Medical Center
Minamikoshigaya
Nagasaki University Hospital
Nagasaki
Nagoya City University Hospital
Nagoya
Kochi Medical School Hospital
Nankoku
Niigata University Medical and Dental Hospital
Niigata
National Hospital Organization Okayama Medical Center
Okayama
Tohoku University Hospital
Sendai
Ntt Medical Center Tokyo
Shinagawa-ku
Tokyo Medical University Hospital
Shinjuku-ku
Osaka University Hospital
Suita
National University Corporation - Tokyo Medical and Dental University (Tmdu)
Tokyo
Juntendo University Urayasu Hospital
Urayasu
Yamagata University Hospital
Yamagata
Mexico
Trials in Medicine S.C.
Deleg. Cuauhtemoc
Instituto de Investigaciones Aplicadas A La Neurociencia A.C
Durango
Centro de Dermatologia de Monterrey
Monterrey
Universidad Autonoma de Nuevo Leon (Uanl) - Hospital Universitario Dr. Jose Eleuterio Gonzalez - Cen
Monterrey
Clinica de Enfermedades Cronicas Y de Procedimientos Especiales (Cecype)
Morelia
Grupo Clínico Catei Sc
Providencia 5ta Seccion
Netherlands
Uva - Amc - Stichting Nederlands Instituut Voor Pigmentstoornissen (Snip) (Netherlands Institute For
Amsterdam
Bravis Ziekenhuis
Bergen Op Zoom
Poland
Dermapolis Medical Dermatology Center Dr N. Med. Edyta Gebska
Chorzów
Synexus Polska Sp Z Oo Oddzial W Czestochowie
Częstochowa
Uniwersyteckie Centrum Kliniczne
Gdansk
Synexus Polska Sp. Z O.O. Oddzial W Katowicach
Katowice
Synexus Polska Sp Z Oo Oddzial W Lodzi
Lodz
Dermodent Centrum Medyczne Aldona Czajkowska Rafa¿ Czajkowski
Osielsko
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Rzeszów
Carpe Diem Centrum Medycyny Estetycznej
Warsaw
Etg Warszawa
Warsaw
Panstwowy Instytut Medyczny Mswia
Warsaw
Synexus Polska Sp. Z O.O. Oddzial W Warszawie
Warsaw
Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia
Wrocaw
Spain
Hospital Universitario Fundacion Alcorcon
Alcorcón
Hospital Universitari Germans Trias I Pujol (Hugtp)
Badalona
Hospital Clinic I Provincial de Barcelona
Barcelona
Clinica Universidad de Navarra (Cun)
Madrid
Hospital Universitario Ramon Y Cajal
Madrid
Hospital de Manises
Manises
Time Frame
Start Date: 2023-11-29
Completion Date: 2027-02-24
Participants
Target number of participants: 467
Treatments
Experimental: Experimental: Povorcitinib Dose A
Participants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
Placebo_comparator: Placebo
Participants will receive Placebo for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
Related Therapeutic Areas
Sponsors
Leads: Incyte Corporation