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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506011-18-00 | 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 |
|---|---|---|---|---|---|---|
| University of Alabama At Birmingham Hospital-Whitaker Clinic | Birmingham | Alabama | 35294-0007 | United States | ||
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| Label | URL |
|---|---|
| A study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2) | 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-VAS190) | ≥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 |
| C2 Research Center, Llc |
| Montgomery |
| Alabama |
| 36117 |
| United States |
| First Oc Dermatology Research Inc | Fountain Valley | California | 92708-3701 | United States |
| Center For Dermatology Clinical Research, Inc | Fremont | California | 94538 | United States |
| Marvel Clinical Research Llc | Huntington Beach | California | 92647 | United States |
| Vitiligo & Pigmentation Institute of Southern California | Los Angeles | California | 90036-5609 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Clinical Trials Research Institute | Thousand Oaks | California | 91320 | United States |
| Skin Care Research, Llc | Boca Raton | Florida | 33486 | United States |
| Total Vein and Skin Llc | Boynton Beach | Florida | 33437 | United States |
| Driven Research Llc | Coral Gables | Florida | 33134 | United States |
| Florida Academic Centers Research and Education Llc | Coral Gables | Florida | 33134 | United States |
| Pediatric Skin Research Llc | Coral Gables | Florida | 33146 | United States |
| Metabolic Research Institute Inc | West Palm Beach | Florida | 33401 | United States |
| Dermatology and Surgery Specialists of North Atlanta | Marietta | Georgia | 30068 | United States |
| Advanced Medical Research Pc | Sandy Springs | Georgia | 30328 | United States |
| Dundee Dermatology | West Dundee | Illinois | 60118 | United States |
| Indiana University School of Medicine Iusm Indianapolis | Indianapolis | Indiana | 46202-3082 | United States |
| Delricht Research | Baton Rouge | Louisiana | 70809 | United States |
| Callender Dermatology and Cosmetic Center | Glenn Dale | Maryland | 20769 | United States |
| Aesthetic and Dermatology Center | Rockville | Maryland | 20850 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Allcutis Research, Llc | Portsmouth | New Hampshire | 03801 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Remington-Davis Clinical Research | Columbus | Ohio | 43215 | United States |
| Oregon Medical Research Center, Pc | Portland | Oregon | 97223 | United States |
| Dermatology Treatment and Research Center | Dallas | Texas | 75230 | United States |
| Heights Dermatology and Aesthetic Center | Houston | Texas | 77008 | United States |
| University of Texas, Md Anderson Cancer | Houston | Texas | 77030 | United States |
| Innovative Dermatology: Legacy Medical Village | Plano | Texas | 75024 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| Medical Center Asklepii Ood | Dupnitsa | 02600 | Bulgaria |
| Medical Center Unimed Eood | Sliven | 05308 | Bulgaria |
| Ambulatory For Specialized Medical Care - Individual Practice For Specialized Medical Care - Skin An | Sofia | 01407 | Bulgaria |
| Aleksandrovska University Hospital | Sofia | 01431 | Bulgaria |
| 28 Diagnostic and Consultative Center | Sofia | 01528 | Bulgaria |
| British Columbia'S Centre For Dermatologic Science - the Skin Care Centre | Vancouver | British Columbia | V5Z 4E8 | Canada |
| Lynderm Research Inc | Markham | Ontario | L3P 1X2 | Canada |
| DERMEDGE | Mississauga | Ontario | L4Y 4C5 | Canada |
| Toronto Research Centre | Toronto | Ontario | M3H 5Y8 | Canada |
| Research Toronto | Toronto | Ontario | M4W 2N4 | Canada |
| Centre de Recherche Dermatologique de Quebec | Québec | Quebec | G1V4X7 | Canada |
| Chru Morvan/Chu Brest Hopital Morvan | Brest | 29200 | France |
| Centre Hospitalier - Le Mans | Le Mans | 72037 | France |
| Cabinet Medical- Chemin de Paradis | Martigues | 13500 | France |
| Centre Hospitalier Universitaire de Nice,Hopital L Archet | Nice | 06200 | France |
| Hopital Charles Nicolle | Rouen | 76031 | France |
| Fachklinik Bad Bentheim | Bad Bentheim | 481455 | Germany |
| Charite Universitaetsmedizin Berlin - Campus Charite Mitte | Berlin | 10117 | Germany |
| University Hospital Carl Gustav Carus | Dresden | 01307 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Dermatologische Gemeinschaftspraxis | Mahlow | 15831 | Germany |
| Universitaetsklinikum Muenster | Münster | 48149 | Germany |
| Orvostudomanyi Kutato Es Fejleszto Kft | Debrecen | 04027 | Hungary |
| Debreceni Egyetem | Debrecen | 04032 | Hungary |
| Markusovszky Teaching Hospital | Szombathely | Hungary |
| Asst Degli Spedali Civili Di Brescia | Brescia | 25123 | Italy |
| Azienda Policlinico Vittorio Emanuele | Catania | 95123 | Italy |
| Fondazione Irccs Ca Granda Ospedale Maggiore | Milan | 20122 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli Irccs | Rome | 00168 | Italy |
| Irccs Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| Synexus Polska Sp. Z O.O. Oddzial W Gdansku | Gdansk | 80-382 | Poland |
| Synexus Gdynia | Gdynia | 81-537 | Poland |
| Provita Sp.Zo.O. Centrum Medyczne Angelius | Katowice | 40-611 | Poland |
| Pro Familia Altera Sp. Z O.O. | Katowice | 40-648 | Poland |
| Prywatny Gabinet Dermatologiczny Elzbieta Klujszo | Kielce | 25-316 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej Dermed Centrum Medyczne Sp. Z O.O. | Lodz | 90-265 | Poland |
| Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak | Lodz | 90-436 | Poland |
| Velocity Clinical Research, Skierniewice | Skierniewice | 96-100 | Poland |
| Laser Clinic | Szczecin | 70-332 | Poland |
| Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | 71-434 | Poland |
| Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z O.O. | Tarnów | 33-100 | Poland |
| Centrum Medyczne Evimed | Warsaw | 02-625 | Poland |
| Royalderm Agnieszka Nawrocka | Warsaw | 02-692 | Poland |
| Klinika Ambroziak Sp. Z O.O. | Warsaw | 02-953 | Poland |
| Futuremeds Targowek Centrum Medyczne Amed Warszawa Targowek | Wrocaw | 03-291 | Poland |
| Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu | Wroclaw | 50-088 | Poland |
| Dermmedica Sp. Z O.O. | Wroclaw | 51-318 | Poland |
| Centrum Medyczne Oporow | Wroclaw | 52-416 | Poland |
| Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust | Ipswich | IP4 5PD | United Kingdom |
| University Hospitals of Leicester-Leicester Royal Infirmary (Lri) | Leicester | LE1 5WW | United Kingdom |
| Whipps Cross University Hospital - Barts Health Nhs Trust | London | E11 1NR | United Kingdom |
| Nottingham University Hospitals - Treatment Center | Nottingham | NG7 2FT | United Kingdom |
| Royal Wolverhampton Nhs Trust | Walsall | WS2 9PS | United Kingdom |