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

August 24, 2026 updated by: Incyte Corporation

A Phase 3, Randomized, Double-Blind, 52-Week, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Nonsegmental Vitiligo

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

467

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel/ Brussels/bruxelles, Belgium, 01070
        • Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel
      • Ghent, Belgium, 09000
        • Universitair Ziekenhuis Gent (Uz Gent)
      • Liège, Belgium, 04000
        • Centre Hospitalier Universitaire de Liege - Sart Tilman
      • Woluwe-Saint-Lambert, Belgium, 01200
        • Cliniques Universitaires UCL Saint-Luc
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Dermatology Research Institute
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 0C6
        • Enverus Medical Research
    • Ontario
      • Burlington, Ontario, Canada, L7R 4H9
        • Leader Research
      • London, Ontario, Canada, N6H 5L5
        • Dermeffects
      • North YORK, Ontario, Canada, M2M 4J5
        • North York Research Inc.
      • Ottawa, Ontario, Canada, K1A 0K9
        • Care Clinic
      • Ottawa, Ontario, Canada, K1A 0K9
        • Siena Medical Research Corporation
      • Peterborough, Ontario, Canada, K9J 5K2
        • Skin Health
      • Waterloo, Ontario, Canada, N2J 1C4
        • Alliance Clinical Trials
  • France
      • Bordeaux, France, 33075
        • Centre Hospitalier Universitaire (Chu) - Hopital Henri Mondor
      • Bordeaux, France, 33075
        • Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
      • Reims, France, 51100
        • Clinique de Courlancy
      • Toulouse, France, 31059
        • Hopital Larrey
  • Germany
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen
      • Frankfurt am Main, Germany, 60590
        • Klinikum Der Johann Wolfgang Goethe University
      • Friedrichshafen, Germany, 88045
        • Derma-Study-Center Friedrichshafen GmbH
      • Mainz, Germany, 55128
        • Dermatologische Gemeinschaftspraxis Dres. Quist
      • Memmingen, Germany, 87700
        • Beldio Research Gmbh
  • Japan
      • Hamamatsu, Japan, 431-3192
        • Hamamatsu University Hospital
      • Kawasaki, Japan, 216-8511
        • St. Marianna University School of Medicine Hospital
      • Kobe, Japan, 6500017
        • Kobe University Hospital
      • Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine
      • Minamikoshigaya, Japan, 343-8555
        • Dokkyo Medical University Saitama Medical Center
      • Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
      • Nagoya, Japan, 467-8602
        • Nagoya City University Hospital
      • Nankoku, Japan, 783-8505
        • Kochi Medical School Hospital
      • Niigata, Japan, 9518520
        • Niigata University Medical And Dental Hospital
      • Okayama, Japan, 701-1192
        • National Hospital Organization Okayama Medical Center
      • Sendai, Japan, 980-8574
        • Tohoku University Hospital
      • Shinagawa-ku, Japan, 141-8625
        • NTT Medical Center Tokyo
      • Shinjuku-ku, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Suita, Japan, 565-0871
        • Osaka University Hospital
      • Tokyo, Japan, 113-8519
        • National University Corporation - Tokyo Medical and Dental University (Tmdu)
      • Urayasu, Japan, 279-0021
        • Juntendo University Urayasu Hospital
      • Yamagata, Japan, 990-9585
        • Yamagata University Hospital
  • Mexico
      • Deleg. Cuauhtemoc, Mexico, 06700
        • Trials in Medicine S.C.
      • Durango, Mexico, 34000
        • Instituto de Investigaciones Aplicadas A La Neurociencia A.C
      • Monterrey, Mexico, 64460
        • Centro de Dermatologia de Monterrey
      • Monterrey, Mexico, 64660
        • Universidad Autonoma de Nuevo Leon (Uanl) - Hospital Universitario Dr. Jose Eleuterio Gonzalez - Cen
      • Morelia, Mexico, 58249
        • Clinica de Enfermedades Cronicas Y de Procedimientos Especiales (Cecype)
      • Providencia 5TA Seccion, Mexico
        • Grupo Clínico Catei Sc
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Uva - Amc - Stichting Nederlands Instituut Voor Pigmentstoornissen (Snip) (Netherlands Institute For
      • Bergen op Zoom, Netherlands, 4624 VT
        • Bravis Ziekenhuis
  • Poland
      • Chorzów, Poland, 41-516
        • Dermapolis Medical Dermatology Center Dr N. Med. Edyta Gebska
      • Częstochowa, Poland, 42-202
        • Synexus Polska Sp Z Oo Oddzial W Czestochowie
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Katowice, Poland, 40-040
        • Synexus Polska Sp. z o.o. Oddzial w Katowicach
      • Lodz, Poland, 90-127
        • Synexus Polska Sp Z Oo Oddzial W Lodzi
      • Osielsko, Poland, 86-031
        • Dermodent Centrum Medyczne Aldona Czajkowska Rafa¿ Czajkowski
      • Ostrowiec Świętokrzyski, Poland, 27-400
        • Dermedic Jacek Zdybski
      • Rzeszów, Poland, 35-055
        • Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
      • Warsaw, Poland, 02-777
        • ETG Warszawa
      • Warsaw, Poland, 02-507
        • PANSTWOWY INSTYTUT MEDYCZNY MSWiA
      • Warsaw, Poland, 02-661
        • Carpe Diem Centrum Medycyny Estetycznej
      • Warsaw, Poland, 02-672
        • Synexus Polska Sp. Z O.O. Oddzial W Warszawie
      • Wrocaw, Poland, 54144
        • Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia
  • Spain
      • Alcorcón, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon
      • Badalona, Spain, 08916
        • Hospital Universitari Germans Trias I Pujol (Hugtp)
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Madrid, Spain, 31008
        • Clinica Universidad de Navarra (Cun)
      • Manises, Spain, 46940
        • Hospital de Manises
  • United States
    • Alabama
      • Hoover, Alabama, United States, 35244
        • Cahaba Dermatology
    • California
      • Irvine, California, United States, 92697
        • University of California Irvine
      • Santa Monica, California, United States, 90404
        • Clinical Science Institute Clinical Research Specialists Inc
      • Sherman Oaks, California, United States, 91403
        • Cura Clinical Research
      • Sunnyvale, California, United States, 94086
        • Sutter Health Palo Alto Medical Foundation Pamf Sunnyvale Center
    • Florida
      • Cape Coral, Florida, United States, 33991
        • Renaissance Research
      • Hollywood, Florida, United States, 33021
        • Encore Medical Research, Llc
      • Miami, Florida, United States, 33173
        • Skin Research of South Florida, Llc
      • Miami, Florida, United States, 33156
        • Savin Medical Group, Rc
      • Miami Lakes, Florida, United States, 33014
        • San Marcus Research Clinic Inc.
      • Tampa, Florida, United States, 33613
        • ForCare Clinical Research
      • Tampa, Florida, United States, 33609
        • Olympian Clinical Research
    • Georgia
      • Cumming, Georgia, United States, 30040
        • Cleaver Medical Group
      • Marietta, Georgia, United States, 30068
        • Dermatology and Surgery Specialists of North Atlanta
      • Stonecrest, Georgia, United States, 30038
        • Pivotal Research Solutions
    • Indiana
      • Kokomo, Indiana, United States, 46901
        • Options Research Group, Llc
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Allcutis Research, Llc
      • Brighton, Massachusetts, United States, 02135-3511
        • Metro Boston Clinical Partners
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Great Lakes Research Group Inc
      • Dearborn, Michigan, United States, 48124
        • Wayne State University Physician Group Dermatology
      • Troy, Michigan, United States, 48084
        • Revival Research Institute, Llc Dermatology
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • MediSearch Clinical Trials
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Jdr Dermatology Research
    • New York
      • East Syracuse, New York, United States, 13057
        • Empire Dermatology
      • New York, New York, United States, 10075
        • Sadick Dermatology Sadick Research Group
      • Stony Brook, New York, United States, 11790
        • Derm Research Center of New York Inc
    • Pennsylvania
      • Plymouth Meeting, Pennsylvania, United States, 19462
        • Dermatology Associates of Plymouth Meeting
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • International Clinical Research Tennessee Llc
    • Texas
      • Bellaire, Texas, United States, 77401
        • University of Texas Physicians - Bellaire Station
      • Houston, Texas, United States, 77004
        • Center for Clinical Studies
      • San Antonio, Texas, United States, 78213
        • Progressive Clinical Research
    • Utah
      • West Jordan, Utah, United States, 84088
        • Jordan Valley Dermatology Center
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Clinical Research Partners Llc Crp Richmond Forest Avenue Office Building Location
    • Washington
      • Spokane, Washington, United States, 99202
        • Dermatology Specialists of Spokane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Povorcitinib Dose A
Participants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
Drug: Povorcitinib
Oral, Tablet
Other Names:
  • INCB054707
Placebo Comparator: Placebo
Participants will receive Placebo for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
Drug: Placebo
Oral, Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
Time Frame: Week 52
≥75% improvement in facial Vitiligo Area Scoring Index.
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving a Vitiligo Noticeability Scale Score (VNS) of 4 or 5
Time Frame: Week 52 and Week 104
VNS is a participant reported outcome measure on a scale of 1-5, 1- more noticeable, 4 - a lot less noticeable, and 5- no longer noticeable.
Week 52 and Week 104
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to Week 104 and 30 days
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Up to Week 104 and 30 days
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)
Time Frame: Week 52 and Week 104
≥50% improvement in facial Vitiligo Area Scoring Index.
Week 52 and Week 104
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)
Time Frame: Week 104
≥75% improvement in facial Vitiligo Area Scoring Index.
Week 104
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50)
Time Frame: Week 104
≥50% improvement in total body Vitiligo Area Scoring Index.
Week 104
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90)
Time Frame: Week 52 and Week 104
≥90% improvement in total body Vitiligo Area Scoring Index.
Week 52 and Week 104
Proportion of participants achieving an Facial Static Investigator Global Assessment (FSIGA) of 0 or 1
Time Frame: Week 52 and Week 104
Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo).
Week 52 and Week 104
Proportion of participants in each Facial Static Investigator Global Assessment (FSIGA) category
Time Frame: Week 52 and Week 104
Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo).
Week 52 and Week 104
Proportion of participants achieving a Static Investigator Global Assessment (SIGA) of 0 (clear) or 1 (almost clear)
Time Frame: Week 52 and Week 104
Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo).
Week 52 and Week 104
Proportion of participants in each Static Investigator Global Assessment (SIGA) category
Time Frame: Week 52 and Week 104
Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo).
Week 52 and Week 104
Proportion of participants who report Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) of 1 or 2
Time Frame: Week 52 and Week 104
F-PaGIC-V is an assessment of improvement of vitiligo on the face by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).
Week 52 and Week 104
Proportion of participants in each Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) category
Time Frame: Week 52 and Week 104
F-PaGIC-V is an assessment of improvement of vitiligo on the face by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).
Week 52 and Week 104
Proportion of participants who report Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) of 1 or 2
Time Frame: Week 52 and Week 104
T-PaGIC-V is an assessment of improvement of vitiligo on the total body by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).
Week 52 and Week 104
Proportion of participants in each Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) category
Time Frame: Week 52 and Week 104
T-PaGIC-V is an assessment of improvement of vitiligo on the total body by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).
Week 52 and Week 104
Proportion of participants in each category for the color-matching question
Time Frame: Week 52 and Week 104
Participants will answer how well the color of the treated skin matches the normal skin on a scale of 1-5, 1 being excellent to 5 being very poor.
Week 52 and Week 104
Change from baseline in the Vitiligo-Specific Quality of Life (VitiQoL)
Time Frame: Week 52 and Week 104
VitiQoL is a 15-item QoL assessment that asks participants to rate various aspects of their condition during the past month using a 7-point scale ("Not at all" to "All of the time").
Week 52 and Week 104
Change from baseline in the Hospital Anxiety and Depression Scale (HADS) subscales
Time Frame: Week 52 and Week 104
HADS is a 14-item questionnaire that assesses the levels of anxiety and depression that a participant is currently experiencing. There are 7 questions each for measuring anxiety and for measuring depression, with 4 possible responses to each question (responses are scored as 0, 1, 2, or 3).
Week 52 and Week 104
Percentage change from Baseline in Total Body Vitiligo Area Scoring Index (T-VASI)
Time Frame: Week 52
Percentage change from Baseline in total body Vitiligo Area Scoring Index.
Week 52
Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)
Time Frame: Week 52
≥50% improvement in total body Vitiligo Area Scoring Index.
Week 52
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75)
Time Frame: Week 52
≥75% improvement in total body Vitiligo Area Scoring Index
Week 52
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)
Time Frame: Week 52 and Week 104
≥90% improvement in facial Vitiligo Area Scoring Index.
Week 52 and Week 104
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75)
Time Frame: Week 104
≥75% improvement in total body Vitiligo Area Scoring Index.
Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Incyte Medical Monitor, Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2023

Primary Completion (Actual)

February 24, 2026

Study Completion (Estimated)

February 24, 2027

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB54707-303
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 2023-505782-86-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

IPD Sharing Time Frame

Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

IPD Sharing Access Criteria

Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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