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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505782-86-00 | Registry Identifier | EU CT Number |
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This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Povorcitinib Dose A | Experimental | Participants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive Placebo for 52 weeks, followed by Povorcitinib Dose A for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povorcitinib | Drug | Oral, Tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) | Percentage change from Baseline in total body Vitiligo Area Scoring Index. | Week 52 |
| Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) |
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Inclusion Criteria:
Aged ≥ 18 years.
Clinical diagnosis of nonsegmental vitiligo and meet the following:
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 protocol-defined Inclusion/Exclusion Criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Dermatology | Hoover | Alabama | 35244 | United States | ||
| University of California Irvine |
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| Label | URL |
|---|---|
| A study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1) | View source |
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Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
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.
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| Placebo | Drug | Oral, Tablet |
|
≥50% improvement in total body Vitiligo Area Scoring Index. |
| Week 52 |
| Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) | ≥75% improvement in total body Vitiligo Area Scoring Index | Week 52 |
| Proportion of participants achieving a Vitiligo Noticeability Scale Score (VNS) of 4 or 5 | 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. | Week 52 and Week 104 |
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to Week 104 and 30 days |
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50) | ≥50% improvement in facial Vitiligo Area Scoring Index. | Week 52 and Week 104 |
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75) | ≥75% improvement in facial Vitiligo Area Scoring Index. | Week 104 |
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90) | ≥90% improvement in facial Vitiligo Area Scoring Index. | Week 52 and Week 104 |
| Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50) | ≥50% improvement in total body Vitiligo Area Scoring Index. | Week 104 |
| Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75) | ≥75% improvement in total body Vitiligo Area Scoring Index. | Week 104 |
| Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90) | ≥90% improvement in total body Vitiligo Area Scoring Index. | Week 52 and Week 104 |
| Proportion of participants achieving an Facial Static Investigator Global Assessment (FSIGA) of 0 or 1 | Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo). | Week 52 and Week 104 |
| Proportion of participants in each Facial Static Investigator Global Assessment (FSIGA) category | Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo). | Week 52 and Week 104 |
| Proportion of participants achieving a Static Investigator Global Assessment (SIGA) of 0 (clear) or 1 (almost clear) | Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo). | Week 52 and Week 104 |
| Proportion of participants in each Static Investigator Global Assessment (SIGA) category | Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo). | Week 52 and Week 104 |
| Proportion of participants who report Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) of 1 or 2 | 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). | Week 52 and Week 104 |
| Proportion of participants in each Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) category | 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). | Week 52 and Week 104 |
| Proportion of participants who report Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) of 1 or 2 | 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). | Week 52 and Week 104 |
| Proportion of participants in each Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) category | 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). | Week 52 and Week 104 |
| Proportion of participants in each category for the color-matching question | 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. | Week 52 and Week 104 |
| Change from baseline in the Vitiligo-Specific Quality of Life (VitiQoL) | 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"). | Week 52 and Week 104 |
| Change from baseline in the Hospital Anxiety and Depression Scale (HADS) subscales | 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). | Week 52 and Week 104 |
| Irvine |
| California |
| 92697 |
| United States |
| Clinical Science Institute Clinical Research Specialists Inc | Santa Monica | California | 90404 | United States |
| Cura Clinical Research | Sherman Oaks | California | 91403 | United States |
| Sutter Health Palo Alto Medical Foundation Pamf Sunnyvale Center | Sunnyvale | California | 94086 | United States |
| Renaissance Research | Cape Coral | Florida | 33991 | United States |
| Encore Medical Research, Llc | Hollywood | Florida | 33021 | United States |
| Savin Medical Group, Rc | Miami | Florida | 33156 | United States |
| Skin Research of South Florida, Llc | Miami | Florida | 33173 | United States |
| San Marcus Research Clinic Inc. | Miami Lakes | Florida | 33014 | United States |
| Olympian Clinical Research | Tampa | Florida | 33609 | United States |
| Forcare Clinical Research | Tampa | Florida | 33613 | United States |
| Cleaver Medical Group | Cumming | Georgia | 30040 | United States |
| Dermatology and Surgery Specialists of North Atlanta | Marietta | Georgia | 30068 | United States |
| Pivotal Research Solutions | Stonecrest | Georgia | 30038 | United States |
| Options Research Group, Llc | Kokomo | Indiana | 46901 | United States |
| Allcutis Research, Llc | Beverly | Massachusetts | 01915 | United States |
| Metro Boston Clinical Partners | Brighton | Massachusetts | 02135-3511 | United States |
| Great Lakes Research Group Inc | Bay City | Michigan | 48706 | United States |
| Wayne State University Physician Group Dermatology | Dearborn | Michigan | 48124 | United States |
| Revival Research Institute, Llc Dermatology | Troy | Michigan | 48084 | United States |
| Medisearch Clinical Trials | Saint Joseph | Missouri | 64506 | United States |
| Jdr Dermatology Research | Las Vegas | Nevada | 89148 | United States |
| Empire Dermatology | East Syracuse | New York | 13057 | United States |
| Sadick Dermatology Sadick Research Group | New York | New York | 10075 | United States |
| Derm Research Center of New York Inc | Stony Brook | New York | 11790 | United States |
| Dermatology Associates of Plymouth Meeting | Plymouth Meeting | Pennsylvania | 19462 | United States |
| International Clinical Research Tennessee Llc | Murfreesboro | Tennessee | 37130 | United States |
| University of Texas Physicians - Bellaire Station | Bellaire | Texas | 77401 | United States |
| Center For Clinical Studies | Houston | Texas | 77004 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Jordan Valley Dermatology Center | West Jordan | Utah | 84088 | United States |
| Clinical Research Partners Llc Crp Richmond Forest Avenue Office Building Location | Richmond | Virginia | 23226 | United States |
| Dermatology Specialists of Spokane | Spokane | Washington | 99202 | United States |
| Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel | Brussel/ Brussels/bruxelles | 01070 | Belgium |
| Universitair Ziekenhuis Gent (Uz Gent) | Ghent | 09000 | Belgium |
| Centre Hospitalier Universitaire de Liege - Sart Tilman | Liège | 04000 | Belgium |
| Cliniques Universitaires Ucl Saint-Luc | Woluwe-Saint-Lambert | 01200 | Belgium |
| Dermatology Research Institute | Calgary | Alberta | T2J 7E1 | Canada |
| Enverus Medical Research | Surrey | British Columbia | V3V 0C6 | Canada |
| Leader Research | Burlington | Ontario | L7R 4H9 | Canada |
| Dermeffects | London | Ontario | N6H 5L5 | Canada |
| North York Research Inc. | North YORK | Ontario | M2M 4J5 | Canada |
| Care Clinic | Ottawa | Ontario | K1A 0K9 | Canada |
| Siena Medical Research Corporation | Ottawa | Ontario | K1A 0K9 | Canada |
| Skin Health | Peterborough | Ontario | K9J 5K2 | Canada |
| Alliance Clinical Trials | Waterloo | Ontario | N2J 1C4 | Canada |
| Centre Hospitalier Universitaire (Chu) - Hopital Henri Mondor | Bordeaux | 33075 | France |
| Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre | Bordeaux | 33075 | France |
| Clinique de Courlancy | Reims | 51100 | France |
| Hopital Larrey | Toulouse | 31059 | France |
| Universitatsklinikum Erlangen | Erlangen | 91054 | Germany |
| Klinikum Der Johann Wolfgang Goethe University | Frankfurt am Main | 60590 | Germany |
| Derma-Study-Center Friedrichshafen Gmbh | Friedrichshafen | 88045 | Germany |
| Dermatologische Gemeinschaftspraxis Dres. Quist | Mainz | 55128 | Germany |
| Beldio Research Gmbh | Memmingen | 87700 | Germany |
| Hamamatsu University Hospital | Hamamatsu | 431-3192 | Japan |
| St. Marianna University School of Medicine Hospital | Kawasaki | 216-8511 | Japan |
| Kobe University Hospital | Kobe | 6500017 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| Dokkyo Medical University Saitama Medical Center | Minamikoshigaya | 343-8555 | Japan |
| Nagasaki University Hospital | Nagasaki | 852-8501 | Japan |
| Nagoya City University Hospital | Nagoya | 467-8602 | Japan |
| Kochi Medical School Hospital | Nankoku | 783-8505 | Japan |
| Niigata University Medical and Dental Hospital | Niigata | 9518520 | Japan |
| National Hospital Organization Okayama Medical Center | Okayama | 701-1192 | Japan |
| Tohoku University Hospital | Sendai | 980-8574 | Japan |
| Ntt Medical Center Tokyo | Shinagawa-ku | 141-8625 | Japan |
| Tokyo Medical University Hospital | Shinjuku-ku | 160-0023 | Japan |
| Osaka University Hospital | Suita | 565-0871 | Japan |
| National University Corporation - Tokyo Medical and Dental University (Tmdu) | Tokyo | 113-8519 | Japan |
| Juntendo University Urayasu Hospital | Urayasu | 279-0021 | Japan |
| Yamagata University Hospital | Yamagata | 990-9585 | Japan |
| Trials in Medicine S.C. | Deleg. Cuauhtemoc | 06700 | Mexico |
| Instituto de Investigaciones Aplicadas A La Neurociencia A.C | Durango | 34000 | Mexico |
| Centro de Dermatologia de Monterrey | Monterrey | 64460 | Mexico |
| Universidad Autonoma de Nuevo Leon (Uanl) - Hospital Universitario Dr. Jose Eleuterio Gonzalez - Cen | Monterrey | 64660 | Mexico |
| Clinica de Enfermedades Cronicas Y de Procedimientos Especiales (Cecype) | Morelia | 58249 | Mexico |
| Grupo Clínico Catei Sc | Providencia 5TA Seccion | Mexico |
| Uva - Amc - Stichting Nederlands Instituut Voor Pigmentstoornissen (Snip) (Netherlands Institute For | Amsterdam | 1105 AZ | Netherlands |
| Bravis Ziekenhuis | Bergen op Zoom | 4624 VT | Netherlands |
| Dermapolis Medical Dermatology Center Dr N. Med. Edyta Gebska | Chorzów | 41-516 | Poland |
| Synexus Polska Sp Z Oo Oddzial W Czestochowie | Częstochowa | 42-202 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-214 | Poland |
| Synexus Polska Sp. Z O.O. Oddzial W Katowicach | Katowice | 40-040 | Poland |
| Synexus Polska Sp Z Oo Oddzial W Lodzi | Lodz | 90-127 | Poland |
| Dermodent Centrum Medyczne Aldona Czajkowska Rafa¿ Czajkowski | Osielsko | 86-031 | Poland |
| Dermedic Jacek Zdybski | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie | Rzeszów | 35-055 | Poland |
| Panstwowy Instytut Medyczny Mswia | Warsaw | 02-507 | Poland |
| Carpe Diem Centrum Medycyny Estetycznej | Warsaw | 02-661 | Poland |
| Synexus Polska Sp. Z O.O. Oddzial W Warszawie | Warsaw | 02-672 | Poland |
| Etg Warszawa | Warsaw | 02-777 | Poland |
| Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia | Wrocaw | 54144 | Poland |
| Hospital Universitario Fundacion Alcorcon | Alcorcón | 28922 | Spain |
| Hospital Universitari Germans Trias I Pujol (Hugtp) | Badalona | 08916 | Spain |
| Hospital Clinic I Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Ramon Y Cajal | Madrid | 28034 | Spain |
| Clinica Universidad de Navarra (Cun) | Madrid | 31008 | Spain |
| Hospital de Manises | Manises | 46940 | Spain |