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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505804-42-00 | Registry Identifier | CTIS (EU) |
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This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV).
Ritlecitinib is studied in patients with non-segmental vitiligo. Vitiligo is a chronic acquired depigmentation disorder characterized by well-defined pale white patches of skin.
Non-segmental vitiligo is an autoimmune disorder and is the focus of this study. The study will show:
This study is seeking for participants who:
All participants in this study will receive the study medicine or placebo. The study medicine (ritlecitinib 50 milligrams or 100 milligrams) or placebo are capsules that are taken by mouth at home every day. On study visit days, you must take the medication at the study site, and not at home.
Participants may receive the study medicine or placebo for up to 52 weeks.
The study will look at the experiences of people receiving the study medicine. This will help see if ritlecitinib is better for treating vitiligo.
Participants will be involved in this study for a maximum of 60 weeks. During this time, they will have 9 study visits during the study.
Ritlecitinib 50 mg is an approved drug for the treatment of severe Alopecia Areata (a disease with similar abnormal changes in the body functions like vitiligo) in the US, EU and Japan. China, Great Britain and other market applications are pending.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Participants who previously received 1 ritlecitinib 50 mg capsule QD orally from BL to Week 52 in Study B7981040. Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned. |
|
| Arm 2 | Experimental | Participants who previously received 1 placebo 50 mg capsule QD orally from BL to Week 52 in Study B7981040 Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritlecitinib | Drug | Ritlecitinib 50 mg capsule once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation | To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo | Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination) |
| Incidence of clinically significant laboratory abnormalities | To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo | Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination) |
| Measure | Description | Time Frame |
|---|---|---|
| Response based on T-VASI75 at weeks 4, 8, 12, 24, 36 and 52 | Proportion of participants achieving at least a 75% improvement in T-VASI from Baseline | Baseline to week 52 |
| Response based on F-VASI75 at weeks 4, 8, 12, 24, 36 and 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Dermatology & Clinical Research Institute | Encinitas | California | 92024 | United States | ||
| Marvel Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42171987 | Derived | Lukic T, Ghosh P, Napatalung L, Wang C, Kurosky SK, Hamzavi I, Sinclair R, Xiang L, Steil K, Rosmarin D, Parsad D, Ezzedine K, Adiri R. Description of the Tranquillo Phase 3 Clinical Trial Designs/Study Protocols to Assess Ritlecitinib in Adults and Adolescents with Nonsegmental Vitiligo. Dermatol Ther (Heidelb). 2026 Jul;16(7):3709-3727. doi: 10.1007/s13555-026-01724-y. Epub 2026 May 22. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Ritlecitinib 100 mg |
| Drug |
Ritlecitinib 100 mg capsule once daily |
|
| Placebo | Drug | Matching capsule once daily |
|
Proportion of participants achieving at least a 75% improvement in F-VASI from Baseline
| Baseline to week 52 |
| Response based on T-VASI50 at weeks 4, 8, 12, 24, 36 and 52 | Proportion of participants achieving at least a 50% improvement in T-VASI from Baseline | Baseline to Week 52 |
| Response based on F-VASI50 at weeks 4, 8, 12, 24, 36 and 52 | Proportion of participants achieving at least a 50% improvement in F-VASI from Baseline | Baseline to week 52 |
| Response based on T-VASI90 at weeks 4, 8, 12, 24, 36 and 52 | Proportion of participants achieving at least a 90% improvement in T-VASI from Baseline | Baseline to week 52 |
| Response based on F-VASI90 at weeks 4, 8, 12, 24, 36 and 52 | Proportion of participants achieving at least a 90% improvement in F-VASI from Baseline | Baseline to week 52 |
| Response based on T-VASI100 at weeks 4, 8, 12, 24, 36 and 52 | Proportion of participants achieving at least a 100% improvement in T-VASI from Baseline | Baseline to week 52 |
| Response based on F-VASI100 at weeks 4, 8, 12, 24, 36 and 52 | Proportion of participants achieving at least a 100% improvement in F-VASI from Baseline | Baseline to week 52 |
| Patient Global Impression of Severity-Face (PGIS-F) at weeks 24, 36, and 52 | To assess the effect of ritlecitinib compared to placebo on the PGIC-F at weeks 24, 36, and 52 | Baseline to week 52 |
| Patient Global Impression of Severity-Overall Vitiligo (PGIS-V) at weeks 24, 36, and 52 | To assess the effect of ritlecitinib compared to placebo on the PGIC-V at Week 24, 36, and 52 | Baseline to week 52 |
| Patient Global Impression of Change-Face (PGIC-F) at week 24, 36, and 52 | To assess the effect of ritlecitinib compared to placebo on the PGIC-F at Week 24, 36, and 52 | Baseline to week 52 |
| Patient Global Impression of Change- Overall vitiligo (PGIC-V) at weeks 24, 36, and 52 | To assess the effect of ritlecitinib compared to placebo on the PGIC-V at weeks 24, 36, and 52 | Baseline to week 52 |
| Proportion of participants achieving disease stabilization | The difference in the proportion of participants with stable disease at all scheduled timepoints | Baseline to week 52 |
| Percentage change from baseline (%CFB) in F-VASI at weeks 4, 8, 12, 24, 36, and 52 | To compare the efficacy of ritlecitinib 100mg QD, 50mg QD, and placebo | Baseline to week 52 |
| Percentage change from baseline (%CFB) in T-VASI at weeks 4, 8, 12, 24, 36, and 52 | To compare the efficacy of ritlecitinib 100mg QD, 50mg QD, and placebo | Baseline to week 52 |
| Time to loss of response (<F-VASI75 and <T-VASI50 at the same visit). | To compare the efficacy of ritlecitinib 100 mg QD, 50 mg QD, and placebo | Baseline to week 52 |
| Huntington Beach |
| California |
| 92647 |
| United States |
| Wallace Medical Group, Inc | Los Angeles | California | 90056 | United States |
| Encore Medical Research of Boynton Beach | Boynton Beach | Florida | 33436 | United States |
| Skin Care Research | Hollywood | Florida | 33021 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| DelRicht Research | Baton Rouge | Louisiana | 70809 | United States |
| Lawrence J. Green, MD LLC | Rockville | Maryland | 20850 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of New Mexico Health Sciences Center | Albuquerque | New Mexico | 87102 | United States |
| SUNY Downstate Health Sciences University | Brooklyn | New York | 11203 | United States |
| University of North Carolina Medical Center | Chapel Hill | North Carolina | 27516 | United States |
| Clinical & Translational Research Center (CTRC) | Chapel Hill | North Carolina | 27599 | United States |
| Accellacare - Wilmington | Wilmington | North Carolina | 28411 | United States |
| Wilmington Health, PLLC | Wilmington | North Carolina | 28411 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Remington-Davis, Inc | Columbus | Ohio | 43215 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Modern Research Associates, PLLC | Dallas | Texas | 75231 | United States |
| Alpesh D. Desai, DO PLLC | Houston | Texas | 77008 | United States |
| Austin Institute for Clinical Research | Houston | Texas | 77056 | United States |
| The Skin Hospital | Darlinghurst | New South Wales | 2010 | Australia |
| North Eastern Health Specialists | Campbelltown | South Australia | 5074 | Australia |
| Skin Health Institute Inc. | Carlton | Victoria | 3053 | Australia |
| Dr Rodney Sinclair Pty Ltd | East Melbourne | Victoria | 3002 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Medical Centre "Asklepiy" | Dupnitsa | Kyustendil | 2600 | Bulgaria |
| Diagnostic Consultative Center Aleksandrovska | Sofia | Sofia (stolitsa) | 1431 | Bulgaria |
| UMHAT "Prof. Dr. Stoyan Kirkovich"AD | Stara Zagora | 6003 | Bulgaria |
| Dermatology Research Institute | Calgary | Alberta | T2J 7E1 | Canada |
| CaRe Clinic | Red Deer | Alberta | T4P 1K4 | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X3 | Canada |
| DermEdge Research | Mississauga | Ontario | L4Y 4C5 | Canada |
| North York Research Inc | Toronto | Ontario | M2N3A6 | Canada |
| Centre de Recherche Dermatologique du Quebec metropolitain | Québec | G1V 4X7 | Canada |
| Centre de Recherche Saint-Louis inc. | Québec | G1W 4R4 | Canada |
| Dermatology Hospital of Southern Medical University | Guangzhou | Guangdong | 510091 | China |
| The First Hospital of Wuhan | Wuhan | Hubei | 430022 | China |
| The First Hospital of China Medical University/Dermatology and STD Department | Shenyang | Liaoning | 110001 | China |
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650032 | China |
| Praxis Leitz und Kollegen | Stuttgart | Baden-Wurttemberg | 70178 | Germany |
| Fachklinik Bad Bentheim | Bad Bentheim | Lower Saxony | 48455 | Germany |
| Universitätsklinikum Münster | Münster | North Rhine-Westphalia | 48149 | Germany |
| Nagoya City University Hospital | Nagoya | Aichi-ken | 467-8602 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Dermatology and Ophthalmology Kume Clinic | Sakai | Osaka | 593-8324 | Japan |
| Nippon Medical School Hospital | Bunkyo-ku | Tokyo | 113-8603 | Japan |
| Tokyo Medical University Hospital | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Yamanashi Prefectural Central Hospital | Kofu | Yamanashi | 400-8506 | Japan |
| Hospital Infantil de Mexico Federico Gomez | Mexico City | Mexico City | 06720 | Mexico |
| Centro de Dermatologia de Monterrey | Monterrey | Nuevo León | 64460 | Mexico |
| Arké SMO S.A de C.V | Veracruz | 91900 | Mexico |
| Sociedad de Metabolismo y Corazon S.C. | Veracruz | 91900 | Mexico |
| DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c. | Osielsko | Kuyavian-Pomeranian Voivodeship | 86-031 | Poland |
| Royalderm Agnieszka Nawrocka | Warsaw | Masovian Voivodeship | 02-962 | Poland |
| Twoja Przychodnia SCM | Szczecin | West Pomeranian Voivodeship | 71-500 | Poland |
| Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak | Lodz | Łódź Voivodeship | 90-436 | Poland |
| Dermedic Jacek Zdybski | Ostrowiec Świętokrzyski | Świętokrzyskie Voivodeship | 27-400 | Poland |
| The Catholic University Of Korea St. Vincent's Hospital | Suwon | Kyǒnggi-do | 16247 | South Korea |
| Ajou University Hospital | Suwon | Kyǒnggi-do | 16499 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | Seoul-teukbyeolsi [seoul] | 03722 | South Korea |
| Hospital Universitario Reina Sofia | Córdoba | Andalusia | 14004 | Spain |
| Hospital Clínic de Barcelona | Barcelona | Catalunya [cataluña] | 08036 | Spain |
| Hospital Universitario de Gran Canaria Doctor Negrín | Las Palmas de Gran Canaria | LAS Palmas | 35010 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Madrid, Comunidad de | 28034 | Spain |
| AUDIKA | Córdoba | 14001 | Spain |
| Marmara Universitesi Pendik Egitim Arastirma Hastanesi | Istanbul | İ̇stanbul | 34899 | Turkey (Türkiye) |
| Istanbul Universitesi Cerrahpasa | Istanbul | 34098 | Turkey (Türkiye) |
| Erciyes Universitesi Tıp Fakultesi Hastaneleri | Kayseri | Turkey (Türkiye) |
| Celal Bayar University Hafsa Sultan Hospital | Manisa | 45030 | Turkey (Türkiye) |
| Guy's & St Thomas' NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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