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

NCT06113445 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: INCB54707-3032023-505782-86-00
• Study Type: interventional
• Target: 467
• Locations: 10 countries
• Sites: 100

Brief Summary

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

Conditions

NonSegmental Vitiligo

Outcome Measures

Primary Outcomes (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.

  Week 52

Secondary Outcomes (22)

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

  Week 52

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

  Week 52

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

  Week 52

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

  Week 52 and Week 104

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

  Up to Week 104 and 30 days

Study Arms (2)

Experimental: Povorcitinib Dose A

EXPERIMENTAL

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

Drug: Povorcitinib

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Povorcitinib DRUG

Oral, Tablet

Also known as: INCB054707

Experimental: Povorcitinib Dose A

Placebo DRUG

Oral, Tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (100)

Cahaba Dermatology

Hoover, Alabama, 35244, United States

Location

University of California Irvine

Irvine, California, 92697, United States

Location

Clinical Science Institute Clinical Research Specialists Inc

Santa Monica, California, 90404, United States

Location

Cura Clinical Research

Sherman Oaks, California, 91403, United States

Location

Sutter Health Palo Alto Medical Foundation Pamf Sunnyvale Center

Sunnyvale, California, 94086, United States

Location

Renaissance Research

Cape Coral, Florida, 33991, United States

Location

Encore Medical Research, Llc

Hollywood, Florida, 33021, United States

Location

Savin Medical Group, Rc

Miami, Florida, 33156, United States

Location

Skin Research of South Florida, Llc

Miami, Florida, 33173, United States

Location

San Marcus Research Clinic Inc.

Miami Lakes, Florida, 33014, United States

Location

Olympian Clinical Research

Tampa, Florida, 33609, United States

Location

Forcare Clinical Research

Tampa, Florida, 33613, United States

Location

Cleaver Medical Group

Cumming, Georgia, 30040, United States

Location

Dermatology and Surgery Specialists of North Atlanta

Marietta, Georgia, 30068, United States

Location

Pivotal Research Solutions

Stonecrest, Georgia, 30038, United States

Location

Options Research Group, Llc

Kokomo, Indiana, 46901, United States

Location

Allcutis Research, Llc

Beverly, Massachusetts, 01915, United States

Location

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135-3511, United States

Location

Great Lakes Research Group Inc

Bay City, Michigan, 48706, United States

Location

Wayne State University Physician Group Dermatology

Dearborn, Michigan, 48124, United States

Location

Revival Research Institute, Llc Dermatology

Troy, Michigan, 48084, United States

Location

Medisearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Jdr Dermatology Research

Las Vegas, Nevada, 89148, United States

Location

Empire Dermatology

East Syracuse, New York, 13057, United States

Location

Sadick Dermatology Sadick Research Group

New York, New York, 10075, United States

Location

Derm Research Center of New York Inc

Stony Brook, New York, 11790, United States

Location

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, 19462, United States

Location

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, 37130, United States

Location

University of Texas Physicians - Bellaire Station

Bellaire, Texas, 77401, United States

Location

Center For Clinical Studies

Houston, Texas, 77004, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Jordan Valley Dermatology Center

West Jordan, Utah, 84088, United States

Location

Clinical Research Partners Llc Crp Richmond Forest Avenue Office Building Location

Richmond, Virginia, 23226, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel

Brussel/ Brussels/bruxelles, 01070, Belgium

Location

Universitair Ziekenhuis Gent (Uz Gent)

Ghent, 09000, Belgium

Location

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, 04000, Belgium

Location

Cliniques Universitaires Ucl Saint-Luc

Woluwe-Saint-Lambert, 01200, Belgium

Location

Dermatology Research Institute

Calgary, Alberta, T2J 7E1, Canada

Location

Enverus Medical Research

Surrey, British Columbia, V3V 0C6, Canada

Location

Leader Research

Burlington, Ontario, L7R 4H9, Canada

Location

Dermeffects

London, Ontario, N6H 5L5, Canada

Location

North York Research Inc.

North YORK, Ontario, M2M 4J5, Canada

Location

Care Clinic

Ottawa, Ontario, K1A 0K9, Canada

Location

Siena Medical Research Corporation

Ottawa, Ontario, K1A 0K9, Canada

Location

Skin Health

Peterborough, Ontario, K9J 5K2, Canada

Location

Alliance Clinical Trials

Waterloo, Ontario, N2J 1C4, Canada

Location

Centre Hospitalier Universitaire (Chu) - Hopital Henri Mondor

Bordeaux, 33075, France

Location

Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre

Bordeaux, 33075, France

Location

Clinique de Courlancy

Reims, 51100, France

Location

Hopital Larrey

Toulouse, 31059, France

Location

Universitatsklinikum Erlangen

Erlangen, 91054, Germany

Location

Klinikum Der Johann Wolfgang Goethe University

Frankfurt am Main, 60590, Germany

Location

Derma-Study-Center Friedrichshafen Gmbh

Friedrichshafen, 88045, Germany

Location

Dermatologische Gemeinschaftspraxis Dres. Quist

Mainz, 55128, Germany

Location

Beldio Research Gmbh

Memmingen, 87700, Germany

Location

Hamamatsu University Hospital

Hamamatsu, 431-3192, Japan

Location

St. Marianna University School of Medicine Hospital

Kawasaki, 216-8511, Japan

Location

Kobe University Hospital

Kobe, 6500017, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Dokkyo Medical University Saitama Medical Center

Minamikoshigaya, 343-8555, Japan

Location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

Nagoya City University Hospital

Nagoya, 467-8602, Japan

Location

Kochi Medical School Hospital

Nankoku, 783-8505, Japan

Location

Niigata University Medical and Dental Hospital

Niigata, 9518520, Japan

Location

National Hospital Organization Okayama Medical Center

Okayama, 701-1192, Japan

Location

Tohoku University Hospital

Sendai, 980-8574, Japan

Location

Ntt Medical Center Tokyo

Shinagawa-ku, 141-8625, Japan

Location

Tokyo Medical University Hospital

Shinjuku-ku, 160-0023, Japan

Location

Osaka University Hospital

Suita, 565-0871, Japan

Location

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

Tokyo, 113-8519, Japan

Location

Juntendo University Urayasu Hospital

Urayasu, 279-0021, Japan

Location

Yamagata University Hospital

Yamagata, 990-9585, Japan

Location

Trials in Medicine S.C.

Deleg. Cuauhtemoc, 06700, Mexico

Location

Instituto de Investigaciones Aplicadas A La Neurociencia A.C

Durango, 34000, Mexico

Location

Centro de Dermatologia de Monterrey

Monterrey, 64460, Mexico

Location

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

Monterrey, 64660, Mexico

Location

Clinica de Enfermedades Cronicas Y de Procedimientos Especiales (Cecype)

Morelia, 58249, Mexico

Location

Grupo Clínico Catei Sc

Providencia 5TA Seccion, Mexico

Location

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

Amsterdam, 1105 AZ, Netherlands

Location

Bravis Ziekenhuis

Bergen op Zoom, 4624 VT, Netherlands

Location

Dermapolis Medical Dermatology Center Dr N. Med. Edyta Gebska

Chorzów, 41-516, Poland

Location

Synexus Polska Sp Z Oo Oddzial W Czestochowie

Częstochowa, 42-202, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

Location

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

Katowice, 40-040, Poland

Location

Synexus Polska Sp Z Oo Oddzial W Lodzi

Lodz, 90-127, Poland

Location

Dermodent Centrum Medyczne Aldona Czajkowska Rafa¿ Czajkowski

Osielsko, 86-031, Poland

Location

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie

Rzeszów, 35-055, Poland

Location

Panstwowy Instytut Medyczny Mswia

Warsaw, 02-507, Poland

Location

Carpe Diem Centrum Medycyny Estetycznej

Warsaw, 02-661, Poland

Location

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

Warsaw, 02-672, Poland

Location

Etg Warszawa

Warsaw, 02-777, Poland

Location

Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia

Wrocaw, 54144, Poland

Location

Hospital Universitario Fundacion Alcorcon

Alcorcón, 28922, Spain

Location

Hospital Universitari Germans Trias I Pujol (Hugtp)

Badalona, 08916, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Location

Clinica Universidad de Navarra (Cun)

Madrid, 31008, Spain

Location

Hospital de Manises

Manises, 46940, Spain

Location

Related Links

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

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: November 29, 2023
• Primary Completion: February 24, 2026
• Study Completion (Estimated): February 24, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• 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.

Locations

US (34); DE (5); CA (9); NL (2); ES (6); JP (17); PL (13); BE (4); FR (4); ME (6)