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

NCT06113471 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: INCB54707-3042023-506011-18-00
• Study Type: interventional
• Target: 450
• Locations: 9 countries
• Sites: 86

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 (86)

University of Alabama At Birmingham Hospital-Whitaker Clinic

Birmingham, Alabama, 35294-0007, United States

Location

C2 Research Center, Llc

Montgomery, Alabama, 36117, United States

Location

First Oc Dermatology Research Inc

Fountain Valley, California, 92708-3701, United States

Location

Center For Dermatology Clinical Research, Inc

Fremont, California, 94538, United States

Location

Marvel Clinical Research Llc

Huntington Beach, California, 92647, United States

Location

Vitiligo & Pigmentation Institute of Southern California

Los Angeles, California, 90036-5609, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Clinical Trials Research Institute

Thousand Oaks, California, 91320, United States

Location

Skin Care Research, Llc

Boca Raton, Florida, 33486, United States

Location

Total Vein and Skin Llc

Boynton Beach, Florida, 33437, United States

Location

Driven Research Llc

Coral Gables, Florida, 33134, United States

Location

Florida Academic Centers Research and Education Llc

Coral Gables, Florida, 33134, United States

Location

Pediatric Skin Research Llc

Coral Gables, Florida, 33146, United States

Location

Metabolic Research Institute Inc

West Palm Beach, Florida, 33401, United States

Location

Dermatology and Surgery Specialists of North Atlanta

Marietta, Georgia, 30068, United States

Location

Advanced Medical Research Pc

Sandy Springs, Georgia, 30328, United States

Location

Dundee Dermatology

West Dundee, Illinois, 60118, United States

Location

Indiana University School of Medicine Iusm Indianapolis

Indianapolis, Indiana, 46202-3082, United States

Location

Delricht Research

Baton Rouge, Louisiana, 70809, United States

Location

Callender Dermatology and Cosmetic Center

Glenn Dale, Maryland, 20769, United States

Location

Aesthetic and Dermatology Center

Rockville, Maryland, 20850, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Allcutis Research, Llc

Portsmouth, New Hampshire, 03801, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Remington-Davis Clinical Research

Columbus, Ohio, 43215, United States

Location

Oregon Medical Research Center, Pc

Portland, Oregon, 97223, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

Heights Dermatology and Aesthetic Center

Houston, Texas, 77008, United States

Location

University of Texas, Md Anderson Cancer

Houston, Texas, 77030, United States

Location

Innovative Dermatology: Legacy Medical Village

Plano, Texas, 75024, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

Medical Center Asklepii Ood

Dupnitsa, 02600, Bulgaria

Location

Medical Center Unimed Eood

Sliven, 05308, Bulgaria

Location

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

Sofia, 01407, Bulgaria

Location

Aleksandrovska University Hospital

Sofia, 01431, Bulgaria

Location

28 Diagnostic and Consultative Center

Sofia, 01528, Bulgaria

Location

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

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X2, Canada

Location

DERMEDGE

Mississauga, Ontario, L4Y 4C5, Canada

Location

Toronto Research Centre

Toronto, Ontario, M3H 5Y8, Canada

Location

Research Toronto

Toronto, Ontario, M4W 2N4, Canada

Location

Centre de Recherche Dermatologique de Quebec

Québec, Quebec, G1V4X7, Canada

Location

Chru Morvan/Chu Brest Hopital Morvan

Brest, 29200, France

Location

Centre Hospitalier - Le Mans

Le Mans, 72037, France

Location

Cabinet Medical- Chemin de Paradis

Martigues, 13500, France

Location

Centre Hospitalier Universitaire de Nice,Hopital L Archet

Nice, 06200, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

Fachklinik Bad Bentheim

Bad Bentheim, 481455, Germany

Location

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, 10117, Germany

Location

University Hospital Carl Gustav Carus

Dresden, 01307, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Dermatologische Gemeinschaftspraxis

Mahlow, 15831, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Orvostudomanyi Kutato Es Fejleszto Kft

Debrecen, 04027, Hungary

Location

Debreceni Egyetem

Debrecen, 04032, Hungary

Location

Markusovszky Teaching Hospital

Szombathely, Hungary

Location

Asst Degli Spedali Civili Di Brescia

Brescia, 25123, Italy

Location

Azienda Policlinico Vittorio Emanuele

Catania, 95123, Italy

Location

Fondazione Irccs Ca Granda Ospedale Maggiore

Milan, 20122, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli Irccs

Rome, 00168, Italy

Location

Irccs Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

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

Gdansk, 80-382, Poland

Location

Synexus Gdynia

Gdynia, 81-537, Poland

Location

Provita Sp.Zo.O. Centrum Medyczne Angelius

Katowice, 40-611, Poland

Location

Pro Familia Altera Sp. Z O.O.

Katowice, 40-648, Poland

Location

Prywatny Gabinet Dermatologiczny Elzbieta Klujszo

Kielce, 25-316, Poland

Location

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

Lodz, 90-265, Poland

Location

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

Lodz, 90-436, Poland

Location

Velocity Clinical Research, Skierniewice

Skierniewice, 96-100, Poland

Location

Laser Clinic

Szczecin, 70-332, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-434, Poland

Location

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

Tarnów, 33-100, Poland

Location

Centrum Medyczne Evimed

Warsaw, 02-625, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, 02-692, Poland

Location

Klinika Ambroziak Sp. Z O.O.

Warsaw, 02-953, Poland

Location

Futuremeds Targowek Centrum Medyczne Amed Warszawa Targowek

Wrocaw, 03-291, Poland

Location

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

Wroclaw, 50-088, Poland

Location

Dermmedica Sp. Z O.O.

Wroclaw, 51-318, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 52-416, Poland

Location

Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust

Ipswich, IP4 5PD, United Kingdom

Location

University Hospitals of Leicester-Leicester Royal Infirmary (Lri)

Leicester, LE1 5WW, United Kingdom

Location

Whipps Cross University Hospital - Barts Health Nhs Trust

London, E11 1NR, United Kingdom

Location

Nottingham University Hospitals - Treatment Center

Nottingham, NG7 2FT, United Kingdom

Location

Royal Wolverhampton Nhs Trust

Walsall, WS2 9PS, United Kingdom

Location

Related Links

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

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 27, 2023
• Primary Completion: March 17, 2026
• Study Completion (Estimated): March 16, 2027
• Last Updated: March 31, 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

FR (5); US (33); GB (5); BU (5); CA (6); HU (3); IT (5); PL (18); DE (6)