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NonSegmental VitiligoPhase 3NCT06113471

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

A Phase 3 study testing Povorcitinib in people with NonSegmental Vitiligo, run by Incyte Corporation at 86 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
NonSegmental Vitiligo
What is being tested?
Povorcitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
86 sitesin 9 countries
Study dates
27 Nov 2023to 16 Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

86 sites in 9 countries.

86 sites in 9 countries

United States33 sites

  • Delricht Research

    Baton Rouge, Louisiana, 70809

  • University of Alabama At Birmingham Hospital-Whitaker Clinic

    Birmingham, Alabama, 35294-0007

  • Skin Care Research, Llc

    Boca Raton, Florida, 33486

  • Total Vein and Skin Llc

    Boynton Beach, Florida, 33437

  • Remington-Davis Clinical Research

    Columbus, Ohio, 43215

  • Driven Research Llc

    Coral Gables, Florida, 33134

  • Florida Academic Centers Research and Education Llc

    Coral Gables, Florida, 33134

  • Pediatric Skin Research Llc

    Coral Gables, Florida, 33146

  • Dermatology Treatment and Research Center

    Dallas, Texas, 75230

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • First Oc Dermatology Research Inc

    Fountain Valley, California, 92708-3701

  • Center For Dermatology Clinical Research, Inc

    Fremont, California, 94538

  • Callender Dermatology and Cosmetic Center

    Glenn Dale, Maryland, 20769

  • Heights Dermatology and Aesthetic Center

    Houston, Texas, 77008

  • University of Texas, Md Anderson Cancer

    Houston, Texas, 77030

  • Marvel Clinical Research Llc

    Huntington Beach, California, 92647

  • Indiana University School of Medicine Iusm Indianapolis

    Indianapolis, Indiana, 46202-3082

  • Vitiligo & Pigmentation Institute of Southern California

    Los Angeles, California, 90036-5609

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • Dermatology and Surgery Specialists of North Atlanta

    Marietta, Georgia, 30068

  • C2 Research Center, Llc

    Montgomery, Alabama, 36117

  • Weill Cornell Medical College

    New York, New York, 10065

  • Innovative Dermatology: Legacy Medical Village

    Plano, Texas, 75024

  • Oregon Medical Research Center, Pc

    Portland, Oregon, 97223

  • Allcutis Research, Llc

    Portsmouth, New Hampshire, 03801

  • Aesthetic and Dermatology Center

    Rockville, Maryland, 20850

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas, 78229

  • Advanced Medical Research Pc

    Sandy Springs, Georgia, 30328

  • Premier Clinical Research

    Spokane, Washington, 99202

  • Clinical Trials Research Institute

    Thousand Oaks, California, 91320

  • Dundee Dermatology

    West Dundee, Illinois, 60118

  • Metabolic Research Institute Inc

    West Palm Beach, Florida, 33401

Other trials in United States

Poland18 sites

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

    Gdansk, 80-382

  • Synexus Gdynia

    Gdynia, 81-537

  • Provita Sp.Zo.O. Centrum Medyczne Angelius

    Katowice, 40-611

  • Pro Familia Altera Sp. Z O.O.

    Katowice, 40-648

  • Prywatny Gabinet Dermatologiczny Elzbieta Klujszo

    Kielce, 25-316

  • Niepubliczny Zaklad Opieki Zdrowotnej Dermed Centrum Medyczne Sp. Z O.O.

    Lodz, 90-265

  • Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak

    Lodz, 90-436

  • Velocity Clinical Research, Skierniewice

    Skierniewice, 96-100

  • Laser Clinic

    Szczecin, 70-332

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z O.O.

    Tarnów, 33-100

  • Centrum Medyczne Evimed

    Warsaw, 02-625

  • Royalderm Agnieszka Nawrocka

    Warsaw, 02-692

  • Klinika Ambroziak Sp. Z O.O.

    Warsaw, 02-953

  • Futuremeds Targowek Centrum Medyczne Amed Warszawa Targowek

    Wrocaw, 03-291

  • Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu

    Wroclaw, 50-088

  • Dermmedica Sp. Z O.O.

    Wroclaw, 51-318

  • Centrum Medyczne Oporow

    Wroclaw, 52-416

Other trials in Poland

Canada6 sites

  • Lynderm Research Inc

    Markham, Ontario, L3P 1X2

  • DERMEDGE

    Mississauga, Ontario, L4Y 4C5

  • Centre de Recherche Dermatologique de Quebec

    Québec, Quebec, G1V4X7

  • Toronto Research Centre

    Toronto, Ontario, M3H 5Y8

  • Research Toronto

    Toronto, Ontario, M4W 2N4

  • British Columbia'S Centre For Dermatologic Science - the Skin Care Centre

    Vancouver, British Columbia, V5Z 4E8

Other trials in Canada

Germany6 sites

  • Fachklinik Bad Bentheim

    Bad Bentheim, 481455

  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte

    Berlin, 10117

  • University Hospital Carl Gustav Carus

    Dresden, 01307

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Dermatologische Gemeinschaftspraxis

    Mahlow, 15831

  • Universitaetsklinikum Muenster

    Münster, 48149

Other trials in Germany

Bulgaria5 sites

  • Medical Center Asklepii Ood

    Dupnitsa, 02600

  • Medical Center Unimed Eood

    Sliven, 05308

  • Ambulatory For Specialized Medical Care - Individual Practice For Specialized Medical Care - Skin An

    Sofia, 01407

  • Aleksandrovska University Hospital

    Sofia, 01431

  • 28 Diagnostic and Consultative Center

    Sofia, 01528

Other trials in Bulgaria

France5 sites

  • Chru Morvan/Chu Brest Hopital Morvan

    Brest, 29200

  • Centre Hospitalier - Le Mans

    Le Mans, 72037

  • Cabinet Medical- Chemin de Paradis

    Martigues, 13500

  • Centre Hospitalier Universitaire de Nice,Hopital L Archet

    Nice, 06200

  • Hopital Charles Nicolle

    Rouen, 76031

Other trials in France

Italy5 sites

  • Asst Degli Spedali Civili Di Brescia

    Brescia, 25123

  • Azienda Policlinico Vittorio Emanuele

    Catania, 95123

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milan, 20122

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs

    Rome, 00168

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089

Other trials in Italy

United Kingdom5 sites

  • Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust

    Ipswich, IP4 5PD

  • University Hospitals of Leicester-Leicester Royal Infirmary (Lri)

    Leicester, LE1 5WW

  • Whipps Cross University Hospital - Barts Health Nhs Trust

    London, E11 1NR

  • Nottingham University Hospitals - Treatment Center

    Nottingham, NG7 2FT

  • Royal Wolverhampton Nhs Trust

    Walsall, WS2 9PS

Other trials in United Kingdom

Hungary3 sites

  • Orvostudomanyi Kutato Es Fejleszto Kft

    Debrecen, 04027

  • Debreceni Egyetem

    Debrecen, 04032

  • Markusovszky Teaching Hospital

    Szombathely

Other trials in Hungary

About this study

Official title: 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.

Being tested
Povorcitinib, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PovorcitinibDrug

    Also called INCB054707

    Oral, Tablet

  • PlaceboDrug

    Oral, Tablet

Study groups in NCT06113471
Study groupRoleWhat they receive
Experimental: Povorcitinib Dose AExperimentalParticipants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
Receives: Drug: Povorcitinib
PlaceboPlacebo comparatorParticipants will receive Placebo for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)

    ≥75% improvement in facial Vitiligo Area Scoring Index.

    Measured: Week 52

Secondary outcomes (22)

  1. Percentage change from Baseline in Total Body Vitiligo Area Scoring Index (T-VASI)

    Percentage change from Baseline in total body Vitiligo Area Scoring Index.

    Measured: Week 52

  2. Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)

    ≥50% improvement in total body Vitiligo Area Scoring Index.

    Measured: Week 52

  3. Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75)

    ≥75% improvement in total body Vitiligo Area Scoring Index.

    Measured: Week 52

  4. Proportion of participants achieving a Vitiligo Noticeability Scale Score (VNS) of 4 or 5

    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.

    Measured: Week 52 and Week 104

  5. Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

    Measured: Up to Week 104 and 30 days

  6. Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)

    ≥50% improvement in facial Vitiligo Area Scoring Index.

    Measured: Week 52 and Week 104

  7. Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)

    ≥75% improvement in facial Vitiligo Area Scoring Index.

    Measured: Week 104

  8. Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VAS190)

    ≥90% improvement in facial Vitiligo Area Scoring Index.

    Measured: Week 52 and Week 104

  9. Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50)

    ≥50% improvement in total body Vitiligo Area Scoring Index.

    Measured: Week 104

  10. Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75)

    ≥75% improvement in total body Vitiligo Area Scoring Index.

    Measured: Week 104

  11. Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90)

    ≥90% improvement in total body Vitiligo Area Scoring Index.

    Measured: Week 52 and Week 104

  12. Proportion of participants achieving an Facial Static Investigator Global Assessment (FSIGA) of 0 or 1

    Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo).

    Measured: Week 52 and Week 104

  13. Proportion of participants in each Facial Static Investigator Global Assessment (FSIGA) category

    Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo).

    Measured: Week 52 and Week 104

  14. Proportion of participants achieving a Static Investigator Global Assessment (SIGA) of 0 (clear) or 1 (almost clear)

    Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo).

    Measured: Week 52 and Week 104

  15. Proportion of participants in each Static Investigator Global Assessment (SIGA) category

    Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo).

    Measured: Week 52 and Week 104

  16. Proportion of participants who report Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) of 1 or 2

    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).

    Measured: Week 52 and Week 104

  17. Proportion of participants in each Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) category

    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).

    Measured: Week 52 and Week 104

  18. Proportion of participants who report Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) of 1 or 2

    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).

    Measured: Week 52 and Week 104

  19. Proportion of participants in each Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) category

    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).

    Measured: Week 52 and Week 104

  20. Proportion of participants in each category for the color-matching question

    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.

    Measured: Week 52 and Week 104

  21. Change from baseline in the Vitiligo-Specific Quality of Life (VitiQoL)

    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").

    Measured: Week 52 and Week 104

  22. Change from baseline in the Hospital Anxiety and Depression Scale (HADS) subscales

    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).

    Measured: Week 52 and Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2023
  2. Study start27 Nov 2023
  3. Primary completion17 Mar 2026
  4. Study completion16 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06113471
Sponsor's protocol ID
INCB54707-304
Other IDs
2023-506011-18-00, 2023
Status last verified
Mar 2026
First submitted
27 Oct 2023
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Ezzedine K, Lui H, Eleftheriadou V, Desai SR, Passeron T, Ringuet J, van Geel N, Wolkerstorfer A, Lynde C, Augustin M, Lopez-Estebaranz JL, Grimes P, Rosmarin D, Brown K, Wei S, Karanam S, Kornacki D, Pandya AG. Povorcitinib for nonsegmental vitiligo: two randomized, controlled, phase 3 STOP-V trials. Nat Med. 2026 Nov 2. doi: 10.1038/s41591-026-04739-2. Online ahead of print.

    PubMed 42972109

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Povorcitinib in people with NonSegmental Vitiligo, run by Incyte Corporation at 86 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Poland, Canada, Germany, Bulgaria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06113471, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.

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