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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

467 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-29

Study Completion Date

2027-02-24

Brief Summary

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

Detailed Description

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Conditions

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NonSegmental Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Group Type EXPERIMENTAL

Povorcitinib

Intervention Type DRUG

Oral, Tablet

Placebo

Participants will receive Placebo for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral, Tablet

Interventions

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Povorcitinib

Oral, Tablet

Intervention Type DRUG

Placebo

Oral, Tablet

Intervention Type DRUG

Other Intervention Names

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INCB054707

Eligibility Criteria

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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 from screening through the final safety follow-up visit.
* Willingness to avoid pregnancy or fathering children.

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 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Incyte Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

University of California Irvine

Irvine, California, United States

Site Status

Clinical Science Institute Clinical Research Specialists Inc

Santa Monica, California, United States

Site Status

Cura Clinical Research

Sherman Oaks, California, United States

Site Status

Sutter Health Palo Alto Medical Foundation Pamf Sunnyvale Center

Sunnyvale, California, United States

Site Status

Renaissance Research

Cape Coral, Florida, United States

Site Status

Encore Medical Research, Llc

Hollywood, Florida, United States

Site Status

Savin Medical Group, Rc

Miami, Florida, United States

Site Status

Skin Research of South Florida, Llc

Miami, Florida, United States

Site Status

San Marcus Research Clinic Inc.

Miami Lakes, Florida, United States

Site Status

Olympian Clinical Research

Tampa, Florida, United States

Site Status

Forcare Clinical Research

Tampa, Florida, United States

Site Status

Cleaver Medical Group

Cumming, Georgia, United States

Site Status

Dermatology and Surgery Specialists of North Atlanta

Marietta, Georgia, United States

Site Status

Pivotal Research Solutions

Stonecrest, Georgia, United States

Site Status

Options Research Group, Llc

Kokomo, Indiana, United States

Site Status

Allcutis Research, Llc

Beverly, Massachusetts, United States

Site Status

Metro Boston Clinical Partners

Brighton, Massachusetts, United States

Site Status

Great Lakes Research Group Inc

Bay City, Michigan, United States

Site Status

Wayne State University Physician Group Dermatology

Dearborn, Michigan, United States

Site Status

Revival Research Institute, Llc Dermatology

Troy, Michigan, United States

Site Status

Medisearch Clinical Trials

Saint Joseph, Missouri, United States

Site Status

Jdr Dermatology Research

Las Vegas, Nevada, United States

Site Status

Empire Dermatology

East Syracuse, New York, United States

Site Status

Sadick Dermatology Sadick Research Group

New York, New York, United States

Site Status

Derm Research Center of New York Inc

Stony Brook, New York, United States

Site Status

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, United States

Site Status

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, United States

Site Status

University of Texas Physicians - Bellaire Station

Bellaire, Texas, United States

Site Status

Center For Clinical Studies

Houston, Texas, United States

Site Status

Progressive Clinical Research

San Antonio, Texas, United States

Site Status

Jordan Valley Dermatology Center

West Jordan, Utah, United States

Site Status

Clinical Research Partners Llc Crp Richmond Forest Avenue Office Building Location

Richmond, Virginia, United States

Site Status

Dermatology Specialists of Spokane

Spokane, Washington, United States

Site Status

Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel

Brussel/ Brussels/bruxelles, , Belgium

Site Status

Universitair Ziekenhuis Gent (Uz Gent)

Ghent, , Belgium

Site Status

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, , Belgium

Site Status

Cliniques Universitaires Ucl Saint-Luc

Woluwe-Saint-Lambert, , Belgium

Site Status

Dermatology Research Institute

Calgary, Alberta, Canada

Site Status

Enverus Medical Research

Surrey, British Columbia, Canada

Site Status

Leader Research

Burlington, Ontario, Canada

Site Status

Dermeffects

London, Ontario, Canada

Site Status

North York Research Inc.

North YORK, Ontario, Canada

Site Status

Care Clinic

Ottawa, Ontario, Canada

Site Status

Siena Medical Research Corporation

Ottawa, Ontario, Canada

Site Status

Skin Health

Peterborough, Ontario, Canada

Site Status

Alliance Clinical Trials

Waterloo, Ontario, Canada

Site Status

Centre Hospitalier Universitaire (Chu) - Hopital Henri Mondor

Bordeaux, , France

Site Status

Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre

Bordeaux, , France

Site Status

Clinique de Courlancy

Reims, , France

Site Status

Hopital Larrey

Toulouse, , France

Site Status

Universitatsklinikum Erlangen

Erlangen, , Germany

Site Status

Klinikum Der Johann Wolfgang Goethe University

Frankfurt am Main, , Germany

Site Status

Derma-Study-Center Friedrichshafen Gmbh

Friedrichshafen, , Germany

Site Status

Dermatologische Gemeinschaftspraxis Dres. Quist

Mainz, , Germany

Site Status

Beldio Research Gmbh

Memmingen, , Germany

Site Status

Hamamatsu University Hospital

Hamamatsu, , Japan

Site Status

St. Marianna University School of Medicine Hospital

Kawasaki, , Japan

Site Status

Kobe University Hospital

Kobe, , Japan

Site Status

University Hospital Kyoto Prefectural University of Medicine

Kyoto, , Japan

Site Status

Dokkyo Medical University Saitama Medical Center

Minamikoshigaya, , Japan

Site Status

Nagasaki University Hospital

Nagasaki, , Japan

Site Status

Nagoya City University Hospital

Nagoya, , Japan

Site Status

Kochi Medical School Hospital

Nankoku, , Japan

Site Status

Niigata University Medical and Dental Hospital

Niigata, , Japan

Site Status

National Hospital Organization Okayama Medical Center

Okayama, , Japan

Site Status

Tohoku University Hospital

Sendai, , Japan

Site Status

Ntt Medical Center Tokyo

Shinagawa-ku, , Japan

Site Status

Tokyo Medical University Hospital

Shinjuku-ku, , Japan

Site Status

Osaka University Hospital

Suita, , Japan

Site Status

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

Tokyo, , Japan

Site Status

Juntendo University Urayasu Hospital

Urayasu, , Japan

Site Status

Yamagata University Hospital

Yamagata, , Japan

Site Status

Trials in Medicine S.C.

Deleg. Cuauhtemoc, , Mexico

Site Status

Instituto de Investigaciones Aplicadas A La Neurociencia A.C

Durango, , Mexico

Site Status

Centro de Dermatologia de Monterrey

Monterrey, , Mexico

Site Status

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

Monterrey, , Mexico

Site Status

Clinica de Enfermedades Cronicas Y de Procedimientos Especiales (Cecype)

Morelia, , Mexico

Site Status

Grupo Clínico Catei Sc

Providencia 5TA Seccion, , Mexico

Site Status

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

Amsterdam, , Netherlands

Site Status

Bravis Ziekenhuis

Bergen op Zoom, , Netherlands

Site Status

Dermapolis Medical Dermatology Center Dr N. Med. Edyta Gebska

Chorzów, , Poland

Site Status

Synexus Polska Sp Z Oo Oddzial W Czestochowie

Częstochowa, , Poland

Site Status

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Site Status

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

Katowice, , Poland

Site Status

Synexus Polska Sp Z Oo Oddzial W Lodzi

Lodz, , Poland

Site Status

Dermodent Centrum Medyczne Aldona Czajkowska Rafa¿ Czajkowski

Osielsko, , Poland

Site Status

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, , Poland

Site Status

Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie

Rzeszów, , Poland

Site Status

Panstwowy Instytut Medyczny Mswia

Warsaw, , Poland

Site Status

Carpe Diem Centrum Medycyny Estetycznej

Warsaw, , Poland

Site Status

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

Warsaw, , Poland

Site Status

Etg Warszawa

Warsaw, , Poland

Site Status

Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia

Wrocaw, , Poland

Site Status

Hospital Universitario Fundacion Alcorcon

Alcorcón, , Spain

Site Status

Hospital Universitari Germans Trias I Pujol (Hugtp)

Badalona, , Spain

Site Status

Hospital Clinic I Provincial de Barcelona

Barcelona, , Spain

Site Status

Hospital Universitario Ramon Y Cajal

Madrid, , Spain

Site Status

Clinica Universidad de Navarra (Cun)

Madrid, , Spain

Site Status

Hospital de Manises

Manises, , Spain

Site Status

Countries

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United States Belgium Canada France Germany Japan Mexico Netherlands Poland Spain

Related Links

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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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