A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)
- Conditions
- NonSegmental Vitiligo
- Interventions
- Drug: Placebo
- Registration Number
- NCT06113445
- 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
- 467
-
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 Placebo Placebo Participants will receive Placebo for 52 weeks, followed by Povorcitinib Dose A for 52 weeks. Experimental: Povorcitinib Dose A Povorcitinib Participants will receive Povorcitinib Dose A 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 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.
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 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 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 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 ≥ 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-VASI75) Week 104 ≥75% improvement in facial 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 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 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).
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 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).
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 Achieving Facial Vitiligo Area Scoring Index (F-VASI50) Week 52 and Week 104 ≥50% improvement in facial Vitiligo Area Scoring Index.
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90) Week 52 and Week 104 ≥90% improvement in facial Vitiligo Area Scoring Index.
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 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 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 (100)
Revival Research Institute, Llc Dermatology
🇺🇸Troy, Michigan, United States
Medisearch Clinical Trials
🇺🇸Saint Joseph, Missouri, United States
Jdr Dermatology Research
🇺🇸Las Vegas, Nevada, United States
Empire Dermatology
🇺🇸East Syracuse, New York, United States
Sadick Dermatology Sadick Research Group
🇺🇸New York, New York, United States
Derm Research Center of New York Inc
🇺🇸Stony Brook, New York, United States
Kochi Medical School Hospital
🇯🇵Nankoku, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata, Japan
National Hospital Organization Okayama Medical Center
🇯🇵Okayama-shi, Japan
Tohoku University Hospital
🇯🇵Sendai, Japan
Ntt Medical Center Tokyo
🇯🇵Shinagawa-ku, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku-ku, Japan
Osaka University Hospital
🇯🇵Suita, Japan
National University Corporation - Tokyo Medical and Dental University (Tmdu)
🇯🇵Tokyo, Japan
Dermatology Associates of Plymouth Meeting
🇺🇸Plymouth Meeting, Pennsylvania, United States
International Clinical Research Tennessee Llc
🇺🇸Murfreesboro, Tennessee, United States
University of Texas Physicians - Bellaire Station
🇺🇸Bellaire, Texas, United States
Center For Clinical Studies
🇺🇸Houston, Texas, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Jordan Valley Dermatology Center
🇺🇸West Jordan, Utah, United States
Clinical Research Partners Llc Crp Richmond Forest Avenue Office Building Location
🇺🇸Richmond, Virginia, United States
Dermatology Specialists of Spokane
🇺🇸Spokane, Washington, United States
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel
🇧🇪Brussel/ Brussels/bruxelles, Belgium
Universitair Ziekenhuis Gent (Uz Gent)
🇧🇪Gent, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
🇧🇪Liege, Belgium
Cliniques Universitaires Ucl Saint-Luc
🇧🇪Woluwe-saint-lambert, Belgium
Dermatology Research Institute
🇨🇦Calgary, Alberta, Canada
Enverus Medical Research
🇨🇦Surrey, British Columbia, Canada
Leader Research
🇨🇦Burlington, Ontario, Canada
Dermeffects
🇨🇦London, Ontario, Canada
Juntendo University Urayasu Hospital
🇯🇵Urayasu, Japan
Yamagata University Hospital
🇯🇵Yamagata-shi, Japan
Trials in Medicine S.C.
🇲🇽Deleg. Cuauhtemoc, Mexico
Instituto de Investigaciones Aplicadas A La Neurociencia A.C
🇲🇽Durango, Mexico
Centro de Dermatologia de Monterrey
🇲🇽Monterrey, Mexico
North York Research Inc.
🇨🇦North York, Ontario, Canada
Care Clinic
🇨🇦Ottawa, Ontario, Canada
Siena Medical Research Corporation
🇨🇦Ottawa, Ontario, Canada
Skin Health
🇨🇦Peterborough, Ontario, Canada
Alliance Clinical Trials
🇨🇦Waterloo, Ontario, Canada
Centre Hospitalier Universitaire (Chu) - Hopital Henri Mondor
🇫🇷Bordeaux Cedex, France
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
🇫🇷Bordeaux Cedex, France
Clinique de Courlancy
🇫🇷Reims, France
Hopital Larrey
🇫🇷Toulouse, France
Universitatsklinikum Erlangen
🇩🇪Erlangen, Germany
Klinikum Der Johann Wolfgang Goethe University
🇩🇪Frankfurt Am Main, Germany
Derma-Study-Center Friedrichshafen Gmbh
🇩🇪Friedrichshafen, Germany
Dermatologische Gemeinschaftspraxis Dres. Quist
🇩🇪Mainz, Germany
Beldio Research Gmbh
🇩🇪Memmingen, Germany
Hamamatsu University Hospital
🇯🇵Hamamatsu, Japan
Universidad Autonoma de Nuevo Leon (Uanl) - Hospital Universitario Dr. Jose Eleuterio Gonzalez - Cen
🇲🇽Monterrey, Mexico
Clinica de Enfermedades Cronicas Y de Procedimientos Especiales (Cecype)
🇲🇽Morelia, Mexico
Grupo Clínico Catei Sc
🇲🇽Providencia 5TA Seccion, Mexico
Uva - Amc - Stichting Nederlands Instituut Voor Pigmentstoornissen (Snip) (Netherlands Institute For
🇳🇱Amsterdam, Netherlands
Bravis Ziekenhuis
🇳🇱Bergen Op Zoom, Netherlands
Dermapolis Medical Dermatology Center Dr N. Med. Edyta Gebska
🇵🇱Chorzow, Poland
Synexus Polska Sp Z Oo Oddzial W Czestochowie
🇵🇱Czestochowa, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Synexus Polska Sp. Z O.O. Oddzial W Katowicach
🇵🇱Katowice, Poland
Synexus Polska Sp Z Oo Oddzial W Lodzi
🇵🇱Lodz, Poland
Dermodent Centrum Medyczne Aldona Czajkowska Rafa¿ Czajkowski
🇵🇱Osielsko, Poland
Dermedic Jacek Zdybski
🇵🇱Ostrowiec Swietokrzyski, Poland
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
🇵🇱Rzeszow, Poland
Etg Warszawa
🇵🇱Warsaw, Poland
Panstwowy Instytut Medyczny Mswia
🇵🇱Warszawa, Poland
Carpe Diem Centrum Medycyny Estetycznej
🇵🇱Warszawa, Poland
Synexus Polska Sp. Z O.O. Oddzial W Warszawie
🇵🇱Warszawa, Poland
Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia
🇵🇱Wrocaw, Poland
Hospital Universitario Fundacion Alcorcon
🇪🇸Alcorcon, Spain
Hospital Universitari Germans Trias I Pujol (Hugtp)
🇪🇸Badalona, Spain
Hospital Clinic I Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Ramon Y Cajal
🇪🇸Madrid, Spain
Clinica Universidad de Navarra (Cun)
🇪🇸Madrid, Spain
Hospital de Manises
🇪🇸Manises, Spain
St. Marianna University School of Medicine Hospital
🇯🇵Kawasaki, Japan
Kobe University Hospital
🇯🇵Kobe, Japan
University Hospital Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Dokkyo Medical University Saitama Medical Center
🇯🇵Minamikoshigaya, Japan
Nagasaki University Hospital
🇯🇵Nagasaki-shi, Japan
Nagoya City University Hospital
🇯🇵Nagoya, Japan
Cahaba Dermatology
🇺🇸Hoover, Alabama, United States
University of California Irvine
🇺🇸Irvine, California, United States
Clinical Science Institute Clinical Research Specialists Inc
🇺🇸Santa Monica, California, United States
Cura Clinical Research
🇺🇸Sherman Oaks, California, United States
Sutter Health Palo Alto Medical Foundation Pamf Sunnyvale Center
🇺🇸Sunnyvale, California, United States
Renaissance Research
🇺🇸Cape Coral, Florida, United States
Encore Medical Research, Llc
🇺🇸Hollywood, Florida, United States
San Marcus Research Clinic Inc.
🇺🇸Miami Lakes, Florida, United States
Savin Medical Group, Rc
🇺🇸Miami, Florida, United States
Skin Research of South Florida, Llc
🇺🇸Miami, Florida, United States
Olympian Clinical Research
🇺🇸Tampa, Florida, United States
Forcare Clinical Research
🇺🇸Tampa, Florida, United States
Cleaver Medical Group
🇺🇸Cumming, Georgia, United States
Dermatology and Surgery Specialists of North Atlanta
🇺🇸Marietta, Georgia, United States
Pivotal Research Solutions
🇺🇸Stonecrest, Georgia, United States
Options Research Group, Llc
🇺🇸Kokomo, Indiana, United States
Allcutis Research, Llc
🇺🇸Beverly, Massachusetts, United States
Metro Boston Clinical Partners
🇺🇸Brighton, Massachusetts, United States
Great Lakes Research Group Inc
🇺🇸Bay City, Michigan, United States
Wayne State University Physician Group Dermatology
🇺🇸Dearborn, Michigan, United States