NonSegmental VitiligoPhase 3NCT06113445
A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)
A Phase 3 study testing Povorcitinib in people with NonSegmental Vitiligo, run by Incyte Corporation at 100 sites in 10 countries.
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
- 467 participants
- Where
- 100 sitesin 10 countries
- Study dates
- 29 Nov 2023to 24 Feb 2027
- Phase
- Phase 3
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.
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- 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
100 sites in 10 countries.
100 sites in 10 countries
United States34 sites
Great Lakes Research Group Inc
Bay City, Michigan, 48706
University of Texas Physicians - Bellaire Station
Bellaire, Texas, 77401
Allcutis Research, Llc
Beverly, Massachusetts, 01915
Metro Boston Clinical Partners
Brighton, Massachusetts, 02135-3511
Renaissance Research
Cape Coral, Florida, 33991
Cleaver Medical Group
Cumming, Georgia, 30040
Wayne State University Physician Group Dermatology
Dearborn, Michigan, 48124
Empire Dermatology
East Syracuse, New York, 13057
Encore Medical Research, Llc
Hollywood, Florida, 33021
Cahaba Dermatology
Hoover, Alabama, 35244
Center For Clinical Studies
Houston, Texas, 77004
University of California Irvine
Irvine, California, 92697
Options Research Group, Llc
Kokomo, Indiana, 46901
Jdr Dermatology Research
Las Vegas, Nevada, 89148
Dermatology and Surgery Specialists of North Atlanta
Marietta, Georgia, 30068
Savin Medical Group, Rc
Miami, Florida, 33156
Skin Research of South Florida, Llc
Miami, Florida, 33173
San Marcus Research Clinic Inc.
Miami Lakes, Florida, 33014
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee, 37130
Sadick Dermatology Sadick Research Group
New York, New York, 10075
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462
Clinical Research Partners Llc Crp Richmond Forest Avenue Office Building Location
Richmond, Virginia, 23226
Medisearch Clinical Trials
Saint Joseph, Missouri, 64506
Progressive Clinical Research
San Antonio, Texas, 78213
Clinical Science Institute Clinical Research Specialists Inc
Santa Monica, California, 90404
Cura Clinical Research
Sherman Oaks, California, 91403
Dermatology Specialists of Spokane
Spokane, Washington, 99202
Pivotal Research Solutions
Stonecrest, Georgia, 30038
Derm Research Center of New York Inc
Stony Brook, New York, 11790
Sutter Health Palo Alto Medical Foundation Pamf Sunnyvale Center
Sunnyvale, California, 94086
Olympian Clinical Research
Tampa, Florida, 33609
Forcare Clinical Research
Tampa, Florida, 33613
Revival Research Institute, Llc Dermatology
Troy, Michigan, 48084
Jordan Valley Dermatology Center
West Jordan, Utah, 84088
Japan17 sites
Hamamatsu University Hospital
Hamamatsu, 431-3192
St. Marianna University School of Medicine Hospital
Kawasaki, 216-8511
Kobe University Hospital
Kobe, 6500017
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566
Dokkyo Medical University Saitama Medical Center
Minamikoshigaya, 343-8555
Nagasaki University Hospital
Nagasaki, 852-8501
Nagoya City University Hospital
Nagoya, 467-8602
Kochi Medical School Hospital
Nankoku, 783-8505
Niigata University Medical and Dental Hospital
Niigata, 9518520
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
Tohoku University Hospital
Sendai, 980-8574
Ntt Medical Center Tokyo
Shinagawa-ku, 141-8625
Tokyo Medical University Hospital
Shinjuku-ku, 160-0023
Osaka University Hospital
Suita, 565-0871
National University Corporation - Tokyo Medical and Dental University (Tmdu)
Tokyo, 113-8519
Juntendo University Urayasu Hospital
Urayasu, 279-0021
Yamagata University Hospital
Yamagata, 990-9585
Poland13 sites
Dermapolis Medical Dermatology Center Dr N. Med. Edyta Gebska
Chorzów, 41-516
Synexus Polska Sp Z Oo Oddzial W Czestochowie
Częstochowa, 42-202
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Synexus Polska Sp. Z O.O. Oddzial W Katowicach
Katowice, 40-040
Synexus Polska Sp Z Oo Oddzial W Lodzi
Lodz, 90-127
Dermodent Centrum Medyczne Aldona Czajkowska Rafa¿ Czajkowski
Osielsko, 86-031
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, 27-400
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Rzeszów, 35-055
Panstwowy Instytut Medyczny Mswia
Warsaw, 02-507
Carpe Diem Centrum Medycyny Estetycznej
Warsaw, 02-661
Synexus Polska Sp. Z O.O. Oddzial W Warszawie
Warsaw, 02-672
Etg Warszawa
Warsaw, 02-777
Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia
Wrocaw, 54144
Canada9 sites
Leader Research
Burlington, Ontario, L7R 4H9
Dermatology Research Institute
Calgary, Alberta, T2J 7E1
Dermeffects
London, Ontario, N6H 5L5
North York Research Inc.
North YORK, Ontario, M2M 4J5
Care Clinic
Ottawa, Ontario, K1A 0K9
Siena Medical Research Corporation
Ottawa, Ontario, K1A 0K9
Skin Health
Peterborough, Ontario, K9J 5K2
Enverus Medical Research
Surrey, British Columbia, V3V 0C6
Alliance Clinical Trials
Waterloo, Ontario, N2J 1C4
Mexico6 sites
Trials in Medicine S.C.
Deleg. Cuauhtemoc, 06700
Instituto de Investigaciones Aplicadas A La Neurociencia A.C
Durango, 34000
Centro de Dermatologia de Monterrey
Monterrey, 64460
Universidad Autonoma de Nuevo Leon (Uanl) - Hospital Universitario Dr. Jose Eleuterio Gonzalez - Cen
Monterrey, 64660
Clinica de Enfermedades Cronicas Y de Procedimientos Especiales (Cecype)
Morelia, 58249
Grupo Clínico Catei Sc
Providencia 5TA Seccion
Spain6 sites
Hospital Universitario Fundacion Alcorcon
Alcorcón, 28922
Hospital Universitari Germans Trias I Pujol (Hugtp)
Badalona, 08916
Hospital Clinic I Provincial de Barcelona
Barcelona, 08036
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Clinica Universidad de Navarra (Cun)
Madrid, 31008
Hospital de Manises
Manises, 46940
Germany5 sites
Universitatsklinikum Erlangen
Erlangen, 91054
Klinikum Der Johann Wolfgang Goethe University
Frankfurt am Main, 60590
Derma-Study-Center Friedrichshafen Gmbh
Friedrichshafen, 88045
Dermatologische Gemeinschaftspraxis Dres. Quist
Mainz, 55128
Beldio Research Gmbh
Memmingen, 87700
Belgium4 sites
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel
Brussel/ Brussels/bruxelles, 01070
Universitair Ziekenhuis Gent (Uz Gent)
Ghent, 09000
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 04000
Cliniques Universitaires Ucl Saint-Luc
Woluwe-Saint-Lambert, 01200
France4 sites
Centre Hospitalier Universitaire (Chu) - Hopital Henri Mondor
Bordeaux, 33075
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
Bordeaux, 33075
Clinique de Courlancy
Reims, 51100
Hopital Larrey
Toulouse, 31059
Netherlands2 sites
Uva - Amc - Stichting Nederlands Instituut Voor Pigmentstoornissen (Snip) (Netherlands Institute For
Amsterdam, 1105 AZ
Bravis Ziekenhuis
Bergen op Zoom, 4624 VT
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.
- Conditions
- 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 group | Role | What they receive |
|---|---|---|
| Experimental: Povorcitinib Dose A | Experimental | Participants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks. Receives: Drug: Povorcitinib |
| Placebo | Placebo comparator | Participants 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.
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)
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
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
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
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
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
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
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)
≥75% improvement in facial Vitiligo Area Scoring Index.
Measured: Week 104
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)
≥90% improvement in facial Vitiligo Area Scoring Index.
Measured: Week 52 and Week 104
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50)
≥50% improvement in total body Vitiligo Area Scoring Index.
Measured: Week 104
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75)
≥75% improvement in total body Vitiligo Area Scoring Index.
Measured: Week 104
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted2 Nov 2023
- Study start29 Nov 2023
- Primary completion24 Feb 2026
- Study completion24 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NonSegmental VitiligoStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113445
- Sponsor's protocol ID
- INCB54707-303
- Other IDs
- 2023-505782-86-00, 2023
- Status last verified
- Aug 2026
- First submitted
- 27 Oct 2023
- Last updated
- 25 Aug 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