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

March 27, 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)

450

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

  • Bulgaria
      • Dupnitsa, Bulgaria, 02600
        • Medical Center Asklepii OOD
      • Sliven, Bulgaria, 05308
        • Medical Center Unimed Eood
      • Sofia, Bulgaria, 01407
        • Ambulatory For Specialized Medical Care - Individual Practice For Specialized Medical Care - Skin An
      • Sofia, Bulgaria, 01431
        • Aleksandrovska University Hospital
      • Sofia, Bulgaria, 01528
        • 28 Diagnostic and Consultative Center
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E8
        • British Columbia'S Centre For Dermatologic Science - the Skin Care Centre
    • Ontario
      • Markham, Ontario, Canada, L3P 1X2
        • Lynderm Research Inc
      • Mississauga, Ontario, Canada, L4Y 4C5
        • DermEdge
      • Toronto, Ontario, Canada, M4W 2N4
        • Research Toronto
      • Toronto, Ontario, Canada, M3H 5Y8
        • Toronto Research Centre
    • Quebec
      • Québec, Quebec, Canada, G1V4X7
        • Centre de Recherche Dermatologique de Quebec
  • France
      • Brest, France, 29200
        • Chru Morvan/Chu Brest Hopital Morvan
      • Le Mans, France, 72037
        • Centre Hospitalier - Le Mans
      • Martigues, France, 13500
        • Cabinet Medical- Chemin de Paradis
      • Nice, France, 06200
        • Centre Hospitalier Universitaire de Nice,Hopital L Archet
      • Rouen, France, 76031
        • Hôpital Charles Nicolle
  • Germany
      • Bad Bentheim, Germany, 481455
        • Fachklinik Bad Bentheim
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
      • Dresden, Germany, 01307
        • University Hospital Carl Gustav Carus
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf
      • Mahlow, Germany, 15831
        • Dermatologische Gemeinschaftspraxis
      • Münster, Germany, 48149
        • Universitaetsklinikum Muenster
  • Hungary
      • Debrecen, Hungary, 04027
        • Orvostudomanyi Kutato es Fejleszto Kft
      • Debrecen, Hungary, 04032
        • Debreceni Egyetem
      • Szombathely, Hungary
        • Markusovszky Teaching Hospital
  • Italy
      • Brescia, Italy, 25123
        • Asst Degli Spedali Civili Di Brescia
      • Catania, Italy, 95123
        • Azienda Policlinico Vittorio Emanuele
      • Milan, Italy, 20122
        • Fondazione Irccs Ca Granda Ospedale Maggiore
      • Rome, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Rozzano, Italy, 20089
        • IRCCS Istituto Clinico Humanitas
  • Poland
      • Gdansk, Poland, 80-382
        • Synexus Polska Sp. z o.o. Oddzial w Gdansku
      • Gdynia, Poland, 81-537
        • Synexus Gdynia
      • Katowice, Poland, 40-648
        • Pro Familia Altera Sp. z o.o.
      • Katowice, Poland, 40-611
        • Provita Sp.Zo.O. Centrum Medyczne Angelius
      • Kielce, Poland, 25-316
        • Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
      • Lodz, Poland, 90-436
        • Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak
      • Lodz, Poland, 90-265
        • Niepubliczny Zaklad Opieki Zdrowotnej Dermed Centrum Medyczne Sp. Z O.O.
      • Skierniewice, Poland, 96-100
        • Velocity Clinical Research, Skierniewice
      • Szczecin, Poland, 71-434
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
      • Szczecin, Poland, 70-332
        • Laser Clinic
      • Tarnów, Poland, 33-100
        • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z O.O.
      • Warsaw, Poland, 02-953
        • Klinika Ambroziak Sp. Z O.O.
      • Warsaw, Poland, 02-625
        • Centrum Medyczne Evimed
      • Warsaw, Poland, 02-692
        • Royalderm Agnieszka Nawrocka
      • Wrocaw, Poland, 03-291
        • Futuremeds Targowek Centrum Medyczne Amed Warszawa Targowek
      • Wroclaw, Poland, 52-416
        • Centrum Medyczne Oporow
      • Wroclaw, Poland, 51-318
        • Dermmedica Sp. Z O.O.
      • Wroclaw, Poland, 50-088
        • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
  • United Kingdom
      • Ipswich, United Kingdom, IP4 5PD
        • Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust
      • Leicester, United Kingdom, LE1 5WW
        • University Hospitals of Leicester-Leicester Royal Infirmary (Lri)
      • London, United Kingdom, E11 1NR
        • Whipps Cross University Hospital - Barts Health Nhs Trust
      • Nottingham, United Kingdom, NG7 2FT
        • Nottingham University Hospitals - Treatment Center
      • Walsall, United Kingdom, WS2 9PS
        • Royal Wolverhampton NHS Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0007
        • University of Alabama At Birmingham Hospital-Whitaker Clinic
      • Montgomery, Alabama, United States, 36117
        • C2 Research Center, LLC
    • California
      • Fountain Valley, California, United States, 92708-3701
        • First OC Dermatology Research Inc
      • Fremont, California, United States, 94538
        • Center for Dermatology Clinical Research, Inc
      • Huntington Beach, California, United States, 92647
        • Marvel Clinical Research LLC
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Los Angeles, California, United States, 90036-5609
        • Vitiligo & Pigmentation Institute of Southern California
      • Thousand Oaks, California, United States, 91320
        • Clinical Trials Research Institute
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Skin Care Research, Llc
      • Boynton Beach, Florida, United States, 33437
        • Total Vein and Skin Llc
      • Coral Gables, Florida, United States, 33134
        • Driven Research LLC
      • Coral Gables, Florida, United States, 33134
        • Florida Academic Centers Research and Education LLC
      • Coral Gables, Florida, United States, 33146
        • Pediatric Skin Research LLC
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute Inc
    • Georgia
      • Marietta, Georgia, United States, 30068
        • Dermatology and Surgery Specialists of North Atlanta
      • Sandy Springs, Georgia, United States, 30328
        • Advanced Medical Research PC
    • Illinois
      • West Dundee, Illinois, United States, 60118
        • Dundee Dermatology
    • Indiana
      • Indianapolis, Indiana, United States, 46202-3082
        • Indiana University School of Medicine Iusm Indianapolis
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • DelRicht Research
    • Maryland
      • Glenn Dale, Maryland, United States, 20769
        • Callender Dermatology and Cosmetic Center
      • Rockville, Maryland, United States, 20850
        • Aesthetic and Dermatology Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Allcutis Research, Llc
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Remington-Davis Clinical Research
    • Oregon
      • Portland, Oregon, United States, 97223
        • Oregon Medical Research Center, Pc
    • Texas
      • Dallas, Texas, United States, 75230
        • Dermatology Treatment and Research Center
      • Houston, Texas, United States, 77008
        • Heights Dermatology and Aesthetic Center
      • Houston, Texas, United States, 77030
        • University of Texas, Md Anderson Cancer
      • Plano, Texas, United States, 75024
        • Innovative Dermatology: Legacy Medical Village
      • San Antonio, Texas, United States, 78218
        • Texas Dermatology and Laser Specialists
      • San Antonio, Texas, United States, 78229
        • Dermatology Clinical Research Center of San Antonio
    • Washington
      • Spokane, Washington, United States, 99202
        • Premier Clinical Research

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 Total Body Vitiligo Area Scoring Index (T-VASI75)
Time Frame: Week 104
≥75% improvement in total body Vitiligo Area Scoring Index.
Week 104
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-VAS190)
Time Frame: Week 52 and Week 104
≥90% improvement in facial Vitiligo Area Scoring Index.
Week 52 and 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 27, 2023

Primary Completion (Actual)

March 17, 2026

Study Completion (Estimated)

March 16, 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)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB54707-304
  • 2023-506011-18-00 (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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