A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2)
- Conditions
- NonSegmental Vitiligo
- Interventions
- Drug: Placebo
- Registration Number
- NCT06113471
- Lead Sponsor
- Incyte Corporation
- Brief Summary
This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 450
-
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.
- 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.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: Povorcitinib Dose A Povorcitinib Participants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks. Placebo Placebo Participants will receive Placebo for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
- Primary Outcome Measures
Name Time Method Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) Week 52 ≥75% improvement in facial Vitiligo Area Scoring Index.
- Secondary Outcome Measures
Name Time Method Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75) Week 104 ≥75% improvement in facial Vitiligo Area Scoring Index.
Percentage change from Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) Week 52 Percentage change from Baseline in total body Vitiligo Area Scoring Index.
Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Week 52 ≥50% improvement in total body Vitiligo Area Scoring Index.
Proportion of participants achieving a Vitiligo Noticeability Scale Score (VNS) of 4 or 5 Week 52 and Week 104 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.
Number of participants with Treatment-emergent Adverse Events (TEAEs) Up to Week 104 and 30 days Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Week 52 ≥75% improvement in total body Vitiligo Area Scoring Index.
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VAS190) Week 52 and Week 104 ≥90% improvement in facial Vitiligo Area Scoring Index.
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50) Week 104 ≥50% improvement in total body Vitiligo Area Scoring Index.
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75) Week 104 ≥75% improvement in total body Vitiligo Area Scoring Index.
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90) Week 52 and Week 104 ≥90% improvement in total body Vitiligo Area Scoring Index.
Proportion of participants achieving an Facial Static Investigator Global Assessment (FSIGA) of 0 or 1 Week 52 and Week 104 Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo).
Proportion of participants in each Facial Static Investigator Global Assessment (FSIGA) category Week 52 and Week 104 Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo).
Proportion of participants achieving a Static Investigator Global Assessment (SIGA) of 0 (clear) or 1 (almost clear) Week 52 and Week 104 Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo).
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50) Week 52 and Week 104 ≥50% improvement in facial Vitiligo Area Scoring Index.
Proportion of participants in each Static Investigator Global Assessment (SIGA) category Week 52 and Week 104 Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo).
Proportion of participants who report Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) of 1 or 2 Week 52 and Week 104 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).
Proportion of participants in each Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) category Week 52 and Week 104 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).
Proportion of participants who report Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) of 1 or 2 Week 52 and Week 104 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).
Proportion of participants in each Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) category Week 52 and Week 104 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).
Change from baseline in the Vitiligo-Specific Quality of Life (VitiQoL) Week 52 and Week 104 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").
Proportion of participants in each category for the color-matching question Week 52 and Week 104 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.
Change from baseline in the Hospital Anxiety and Depression Scale (HADS) subscales Week 52 and Week 104 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).
Trial Locations
- Locations (86)
Research Toronto
🇨🇦Toronto, Ontario, Canada
Centre de Recherche Dermatologique de Quebec
🇨🇦Quebec City, Quebec, Canada
Chru Morvan/Chu Brest Hopital Morvan
🇫🇷Brest, France
Centre Hospitalier - Le Mans
🇫🇷Le Mans, France
Cabinet Medical- Chemin de Paradis
🇫🇷Martigues, France
Centre Hospitalier Universitaire de Nice,Hopital L Archet
🇫🇷Nice, France
Hopital Charles Nicolle
🇫🇷Rouen Cedex, France
Fachklinik Bad Bentheim
🇩🇪Bad Bentheim, Germany
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
🇩🇪Berlin, Germany
University Hospital Carl Gustav Carus
🇩🇪Dresden, Germany
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Dermatologische Gemeinschaftspraxis
🇩🇪Mahlow, Germany
Universitaetsklinikum Muenster
🇩🇪Muenster, Germany
Orvostudomanyi Kutato Es Fejleszto Kft
🇭🇺Debrecen, Hungary
Debreceni Egyetem
🇭🇺Debrecen, Hungary
Markusovszky Teaching Hospital
🇭🇺Szombathely, Hungary
Oregon Medical Research Center, Pc
🇺🇸Portland, Oregon, United States
Dermatology Treatment and Research Center
🇺🇸Dallas, Texas, United States
Heights Dermatology and Aesthetic Center
🇺🇸Houston, Texas, United States
University of Texas, Md Anderson Cancer
🇺🇸Houston, Texas, United States
Azienda Policlinico Vittorio Emanuele
🇮🇹Catania, Italy
Fondazione Irccs Ca Granda Ospedale Maggiore
🇮🇹Milano, Italy
University of Alabama At Birmingham Hospital-Whitaker Clinic
🇺🇸Birmingham, Alabama, United States
C2 Research Center, Llc
🇺🇸Montgomery, Alabama, United States
First Oc Dermatology Research Inc
🇺🇸Fountain Valley, California, United States
Center For Dermatology Clinical Research, Inc
🇺🇸Fremont, California, United States
Marvel Clinical Research Llc
🇺🇸Huntington Beach, California, United States
Vitiligo & Pigmentation Institute of Southern California
🇺🇸Los Angeles, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Clinical Trials Research Institute
🇺🇸Thousand Oaks, California, United States
Skin Care Research, Llc
🇺🇸Boca Raton, Florida, United States
Total Vein and Skin Llc
🇺🇸Boynton Beach, Florida, United States
Driven Research Llc
🇺🇸Coral Gables, Florida, United States
Florida Academic Centers Research and Education Llc
🇺🇸Coral Gables, Florida, United States
Pediatric Skin Research Llc
🇺🇸Coral Gables, Florida, United States
Metabolic Research Institute Inc
🇺🇸West Palm Beach, Florida, United States
Dermatology and Surgery Specialists of North Atlanta
🇺🇸Marietta, Georgia, United States
Advanced Medical Research Pc
🇺🇸Sandy Springs, Georgia, United States
Dundee Dermatology
🇺🇸West Dundee, Illinois, United States
Indiana University School of Medicine Iusm Indianapolis
🇺🇸Indianapolis, Indiana, United States
Delricht Research
🇺🇸Baton Rouge, Louisiana, United States
Callender Dermatology and Cosmetic Center
🇺🇸Glenn Dale, Maryland, United States
Aesthetic and Dermatology Center
🇺🇸Rockville, Maryland, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Allcutis Research, Llc
🇺🇸Portsmouth, New Hampshire, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Remington-Davis Clinical Research
🇺🇸Columbus, Ohio, United States
Innovative Dermatology: Legacy Medical Village
🇺🇸Plano, Texas, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
🇺🇸San Antonio, Texas, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
Medical Center Asklepii Ood
🇧🇬Dupnitsa, Bulgaria
Medical Center Unimed Eood
🇧🇬Sliven, Bulgaria
Ambulatory For Specialized Medical Care - Individual Practice For Specialized Medical Care - Skin An
🇧🇬Sofia, Bulgaria
Aleksandrovska University Hospital
🇧🇬Sofia, Bulgaria
28 Diagnostic and Consultative Center
🇧🇬Sofia, Bulgaria
British Columbia'S Centre For Dermatologic Science - the Skin Care Centre
🇨🇦Vancouver, British Columbia, Canada
Lynderm Research Inc
🇨🇦Markham, Ontario, Canada
DERMEDGE
🇨🇦Mississauga, Ontario, Canada
Toronto Research Centre
🇨🇦Toronto, Ontario, Canada
Asst Degli Spedali Civili Di Brescia
🇮🇹Brescia, Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs
🇮🇹Rome, Italy
Irccs Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Synexus Polska Sp. Z O.O. Oddzial W Gdansku
🇵🇱Gdansk, Poland
Synexus Gdynia
🇵🇱Gdynia, Poland
Provita Sp.Zo.O. Centrum Medyczne Angelius
🇵🇱Katowice, Poland
Pro Familia Altera Sp. Z O.O.
🇵🇱Katowice, Poland
Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
🇵🇱Kielce, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Dermed Centrum Medyczne Sp. Z O.O.
🇵🇱Lodz, Poland
Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak
🇵🇱Lodz, Poland
Velocity Clinical Research, Skierniewice
🇵🇱Skierniewice, Poland
Laser Clinic
🇵🇱Szczecin, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z O.O.
🇵🇱Tarnow, Poland
Centrum Medyczne Evimed
🇵🇱Warsaw, Poland
Royalderm Agnieszka Nawrocka
🇵🇱Warszawa, Poland
Klinika Ambroziak Sp. Z O.O.
🇵🇱Warszawa, Poland
Futuremeds Targowek Centrum Medyczne Amed Warszawa Targowek
🇵🇱Wrocaw, Poland
Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu
🇵🇱Wroclaw, Poland
Dermmedica Sp. Z O.O.
🇵🇱Wroclaw, Poland
Centrum Medyczne Oporow
🇵🇱Wroclaw, Poland
Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust
🇬🇧Ipswich, United Kingdom
University Hospitals of Leicester-Leicester Royal Infirmary (Lri)
🇬🇧Leicester, United Kingdom
Whipps Cross University Hospital - Barts Health Nhs Trust
🇬🇧London, United Kingdom
Nottingham University Hospitals - Treatment Center
🇬🇧Nottingham, United Kingdom
Royal Wolverhampton Nhs Trust
🇬🇧Walsall, United Kingdom