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

NCT ID: NCT06113471

Last Updated: 2026-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-27

Study Completion Date

2027-03-16

Brief Summary

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

Detailed Description

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Conditions

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NonSegmental Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental: Povorcitinib Dose A

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

Group Type EXPERIMENTAL

Povorcitinib

Intervention Type DRUG

Oral, Tablet

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral, Tablet

Interventions

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Povorcitinib

Oral, Tablet

Intervention Type DRUG

Placebo

Oral, Tablet

Intervention Type DRUG

Other Intervention Names

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INCB054707

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Incyte Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Incyte Medical Monitor

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

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University of Alabama At Birmingham Hospital-Whitaker Clinic

Birmingham, Alabama, United States

Site Status

C2 Research Center, Llc

Montgomery, Alabama, United States

Site Status

First Oc Dermatology Research Inc

Fountain Valley, California, United States

Site Status

Center For Dermatology Clinical Research, Inc

Fremont, California, United States

Site Status

Marvel Clinical Research Llc

Huntington Beach, California, United States

Site Status

Vitiligo & Pigmentation Institute of Southern California

Los Angeles, California, United States

Site Status

Dermatology Research Associates

Los Angeles, California, United States

Site Status

Clinical Trials Research Institute

Thousand Oaks, California, United States

Site Status

Skin Care Research, Llc

Boca Raton, Florida, United States

Site Status

Total Vein and Skin Llc

Boynton Beach, Florida, United States

Site Status

Driven Research Llc

Coral Gables, Florida, United States

Site Status

Florida Academic Centers Research and Education Llc

Coral Gables, Florida, United States

Site Status

Pediatric Skin Research Llc

Coral Gables, Florida, United States

Site Status

Metabolic Research Institute Inc

West Palm Beach, Florida, United States

Site Status

Dermatology and Surgery Specialists of North Atlanta

Marietta, Georgia, United States

Site Status

Advanced Medical Research Pc

Sandy Springs, Georgia, United States

Site Status

Dundee Dermatology

West Dundee, Illinois, United States

Site Status

Indiana University School of Medicine Iusm Indianapolis

Indianapolis, Indiana, United States

Site Status

Delricht Research

Baton Rouge, Louisiana, United States

Site Status

Callender Dermatology and Cosmetic Center

Glenn Dale, Maryland, United States

Site Status

Aesthetic and Dermatology Center

Rockville, Maryland, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Allcutis Research, Llc

Portsmouth, New Hampshire, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

Remington-Davis Clinical Research

Columbus, Ohio, United States

Site Status

Oregon Medical Research Center, Pc

Portland, Oregon, United States

Site Status

Dermatology Treatment and Research Center

Dallas, Texas, United States

Site Status

Heights Dermatology and Aesthetic Center

Houston, Texas, United States

Site Status

University of Texas, Md Anderson Cancer

Houston, Texas, United States

Site Status

Innovative Dermatology: Legacy Medical Village

Plano, Texas, United States

Site Status

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Site Status

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Site Status

Premier Clinical Research

Spokane, Washington, United States

Site Status

Medical Center Asklepii Ood

Dupnitsa, , Bulgaria

Site Status

Medical Center Unimed Eood

Sliven, , Bulgaria

Site Status

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

Sofia, , Bulgaria

Site Status

Aleksandrovska University Hospital

Sofia, , Bulgaria

Site Status

28 Diagnostic and Consultative Center

Sofia, , Bulgaria

Site Status

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

Vancouver, British Columbia, Canada

Site Status

Lynderm Research Inc

Markham, Ontario, Canada

Site Status

DERMEDGE

Mississauga, Ontario, Canada

Site Status

Toronto Research Centre

Toronto, Ontario, Canada

Site Status

Research Toronto

Toronto, Ontario, Canada

Site Status

Centre de Recherche Dermatologique de Quebec

Québec, Quebec, Canada

Site Status

Chru Morvan/Chu Brest Hopital Morvan

Brest, , France

Site Status

Centre Hospitalier - Le Mans

Le Mans, , France

Site Status

Cabinet Medical- Chemin de Paradis

Martigues, , France

Site Status

Centre Hospitalier Universitaire de Nice,Hopital L Archet

Nice, , France

Site Status

Hopital Charles Nicolle

Rouen, , France

Site Status

Fachklinik Bad Bentheim

Bad Bentheim, , Germany

Site Status

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, , Germany

Site Status

University Hospital Carl Gustav Carus

Dresden, , Germany

Site Status

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Dermatologische Gemeinschaftspraxis

Mahlow, , Germany

Site Status

Universitaetsklinikum Muenster

Münster, , Germany

Site Status

Orvostudomanyi Kutato Es Fejleszto Kft

Debrecen, , Hungary

Site Status

Debreceni Egyetem

Debrecen, , Hungary

Site Status

Markusovszky Teaching Hospital

Szombathely, , Hungary

Site Status

Asst Degli Spedali Civili Di Brescia

Brescia, , Italy

Site Status

Azienda Policlinico Vittorio Emanuele

Catania, , Italy

Site Status

Fondazione Irccs Ca Granda Ospedale Maggiore

Milan, , Italy

Site Status

Fondazione Policlinico Universitario Agostino Gemelli Irccs

Rome, , Italy

Site Status

Irccs Istituto Clinico Humanitas

Rozzano, , Italy

Site Status

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

Gdansk, , Poland

Site Status

Synexus Gdynia

Gdynia, , Poland

Site Status

Provita Sp.Zo.O. Centrum Medyczne Angelius

Katowice, , Poland

Site Status

Pro Familia Altera Sp. Z O.O.

Katowice, , Poland

Site Status

Prywatny Gabinet Dermatologiczny Elzbieta Klujszo

Kielce, , Poland

Site Status

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

Lodz, , Poland

Site Status

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

Lodz, , Poland

Site Status

Velocity Clinical Research, Skierniewice

Skierniewice, , Poland

Site Status

Laser Clinic

Szczecin, , Poland

Site Status

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, , Poland

Site Status

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

Tarnów, , Poland

Site Status

Centrum Medyczne Evimed

Warsaw, , Poland

Site Status

Royalderm Agnieszka Nawrocka

Warsaw, , Poland

Site Status

Klinika Ambroziak Sp. Z O.O.

Warsaw, , Poland

Site Status

Futuremeds Targowek Centrum Medyczne Amed Warszawa Targowek

Wrocaw, , Poland

Site Status

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

Wroclaw, , Poland

Site Status

Dermmedica Sp. Z O.O.

Wroclaw, , Poland

Site Status

Centrum Medyczne Oporow

Wroclaw, , Poland

Site Status

Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust

Ipswich, , United Kingdom

Site Status

University Hospitals of Leicester-Leicester Royal Infirmary (Lri)

Leicester, , United Kingdom

Site Status

Whipps Cross University Hospital - Barts Health Nhs Trust

London, , United Kingdom

Site Status

Nottingham University Hospitals - Treatment Center

Nottingham, , United Kingdom

Site Status

Royal Wolverhampton Nhs Trust

Walsall, , United Kingdom

Site Status

Countries

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United States Bulgaria Canada France Germany Hungary Italy Poland United Kingdom

Related Links

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Other Identifiers

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2023-506011-18-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

INCB54707-304

Identifier Type: -

Identifier Source: org_study_id

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