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Uno studio di 52 settimane per conoscere la sicurezza e gli effetti di ritlecitinib nei partecipanti con vitiligine non segmentale (Tranquillo LTE)

24 settembre 2026 aggiornato da: Pfizer

UNO STUDIO DI ESTENSIONE MULTICENTRALE CON SOSPENSIONE RANDOMIZZATA E DOSE-UP DI FASE 3 CHE investiga la SICUREZZA, L'EFFICACIA E LA TOLLERABILITÀ DI RITLECITINIB IN PARTECIPANTI ADULTI E ADOLESCENTI CON VITILIGINE NON SEGMENTALE

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:

  • if the repigmentation (the recovery of pigmentation) achieved in study B7981040 (also called the "parent study") will stay the same or will further increase if you keep receiving the same study medicine (ritlecitinib 50 milligrams or placebo)
  • Or if more repigmentation can be achieved if you start receiving ritlecitinib 100 milligrams in this study
  • Or how long the repigmentation achieved during the parent study lasts if you start receiving placebo in this study.

This study is seeking for participants who:

  • have non-segmental vitiligo (either active or stable) and
  • received ritlecitinib or placebo for 52 weeks in the parent study. A placebo looks exactly like the study capsule but does not contain any medicine in it.

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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

394

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • The Skin Hospital
    • South Australia
      • Campbelltown, South Australia, Australia, 5074
        • North Eastern Health Specialists
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Skin Health Institute Inc.
      • East Melbourne, Victoria, Australia, 3002
        • Dr Rodney Sinclair Pty Ltd
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
  • Bulgaria
      • Stara Zagora, Bulgaria, 6003
        • UMHAT "Prof. Dr. Stoyan Kirkovich"AD
    • Kyustendil
      • Dupnitsa, Kyustendil, Bulgaria, 2600
        • Medical Centre "Asklepiy"
    • Sofia (stolitsa)
      • Sofia, Sofia (stolitsa), Bulgaria, 1431
        • Diagnostic Consultative Center Aleksandrovska
  • Canada
      • Québec, Canada, G1V 4X7
        • Centre de Recherche Dermatologique du Quebec metropolitain
      • Québec, Canada, G1W 4R4
        • Centre de Recherche Saint-Louis inc.
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Dermatology Research Institute
      • Red Deer, Alberta, Canada, T4P 1K4
        • CaRe Clinic
    • Ontario
      • Markham, Ontario, Canada, L3P 1X3
        • Lynderm Research Inc.
      • Mississauga, Ontario, Canada, L4Y 4C5
        • DermEdge Research
      • Toronto, Ontario, Canada, M2N3A6
        • North York Research Inc
  • Cina
    • Guangdong
      • Guangzhou, Guangdong, Cina, 510091
        • Dermatology Hospital of Southern Medical University
    • Hubei
      • Wuhan, Hubei, Cina, 430022
        • The First Hospital of Wuhan
    • Liaoning
      • Shenyang, Liaoning, Cina, 110001
        • The First Hospital of China Medical University/Dermatology and STD Department
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200040
        • Huashan Hospital Fudan University
    • Yunnan
      • Kunming, Yunnan, Cina, 650032
        • First Affiliated Hospital of Kunming Medical University
  • Corea del Sud
    • Kyǒnggi-do
      • Suwon, Kyǒnggi-do, Corea del Sud, 16247
        • The Catholic University Of Korea St. Vincent's Hospital
      • Suwon, Kyǒnggi-do, Corea del Sud, 16499
        • Ajou University Hospital
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], Corea del Sud, 03722
        • Severance Hospital, Yonsei University Health System
  • Germania
    • Baden-Wurttemberg
      • Stuttgart, Baden-Wurttemberg, Germania, 70178
        • Praxis Leitz und Kollegen
    • Lower Saxony
      • Bad Bentheim, Lower Saxony, Germania, 48455
        • Fachklinik Bad Bentheim
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germania, 48149
        • Universitätsklinikum Münster
  • Giappone
    • Aichi-ken
      • Nagoya, Aichi-ken, Giappone, 467-8602
        • Nagoya City University Hospital
    • Miyagi
      • Sendai, Miyagi, Giappone, 980-8574
        • Tohoku University Hospital
    • Osaka
      • Sakai, Osaka, Giappone, 593-8324
        • Dermatology and Ophthalmology Kume Clinic
    • Tokyo
      • Bunkyo-ku, Tokyo, Giappone, 113-8603
        • Nippon Medical School Hospital
      • Shinjuku-ku, Tokyo, Giappone, 160-0023
        • Tokyo Medical University Hospital
    • Yamanashi
      • Kofu, Yamanashi, Giappone, 400-8506
        • Yamanashi Prefectural Central Hospital
  • Messico
      • Veracruz, Messico, 91900
        • Arké SMO S.A de C.V
      • Veracruz, Messico, 91900
        • Sociedad de Metabolismo y Corazon S.C.
    • Mexico City
      • Mexico City, Mexico City, Messico, 06720
        • Hospital Infantil de Mexico Federico Gomez
    • Nuevo León
      • Monterrey, Nuevo León, Messico, 64460
        • Centro de Dermatologia de Monterrey
  • Polonia
    • Kuyavian-Pomeranian Voivodeship
      • Osielsko, Kuyavian-Pomeranian Voivodeship, Polonia, 86-031
        • DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polonia, 02-962
        • Royalderm Agnieszka Nawrocka
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Polonia, 71-500
        • Twoja Przychodnia SCM
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Polonia, 90-436
        • Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
    • Świętokrzyskie Voivodeship
      • Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Polonia, 27-400
        • Dermedic Jacek Zdybski
  • Regno Unito
      • London, Regno Unito, SE1 9RT
        • Guy's & St Thomas' NHS Foundation Trust
  • Spagna
      • Córdoba, Spagna, 14001
        • AUDIKA
    • Andalusia
      • Córdoba, Andalusia, Spagna, 14004
        • Hospital Universitario Reina Sofia
    • Catalunya [cataluña]
      • Barcelona, Catalunya [cataluña], Spagna, 08036
        • Hospital Clínic de Barcelona
    • LAS Palmas
      • Las Palmas de Gran Canaria, LAS Palmas, Spagna, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrín
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spagna, 28034
        • Hospital Universitario Ramón y Cajal
  • Stati Uniti
    • California
      • Encinitas, California, Stati Uniti, 92024
        • California Dermatology & Clinical Research Institute
      • Huntington Beach, California, Stati Uniti, 92647
        • Marvel Clinical Research
      • Los Angeles, California, Stati Uniti, 90056
        • Wallace Medical Group, Inc
    • Florida
      • Boynton Beach, Florida, Stati Uniti, 33436
        • Encore Medical Research of Boynton Beach
      • Hollywood, Florida, Stati Uniti, 33021
        • Skin Care Research
      • Tampa, Florida, Stati Uniti, 33613
        • ForCare Clinical Research
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46250
        • Dawes Fretzin Clinical Research Group, LLC
    • Louisiana
      • Baton Rouge, Louisiana, Stati Uniti, 70809
        • DelRicht Research
    • Maryland
      • Rockville, Maryland, Stati Uniti, 20850
        • Lawrence J. Green, MD LLC
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109
        • University of Michigan
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87102
        • University of New Mexico Health Sciences Center
    • New York
      • Brooklyn, New York, Stati Uniti, 11203
        • SUNY Downstate Health Sciences University
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27516
        • University of North Carolina Medical Center
      • Chapel Hill, North Carolina, Stati Uniti, 27599
        • Clinical & Translational Research Center (CTRC)
      • Wilmington, North Carolina, Stati Uniti, 28411
        • Accellacare - Wilmington
      • Wilmington, North Carolina, Stati Uniti, 28411
        • Wilmington Health, PLLC
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44106
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, Stati Uniti, 43215
        • Remington-Davis, Inc
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, Stati Uniti, 75231
        • Modern Research Associates, PLLC
      • Houston, Texas, Stati Uniti, 77056
        • Austin Institute for Clinical Research
      • Houston, Texas, Stati Uniti, 77008
        • Alpesh D. Desai, DO PLLC
  • Turchia (Türkiye)
      • Istanbul, Turchia (Türkiye), 34098
        • Istanbul Universitesi Cerrahpasa
      • Kayseri, Turchia (Türkiye)
        • Erciyes Universitesi Tıp Fakultesi Hastaneleri
      • Manisa, Turchia (Türkiye), 45030
        • Celal Bayar University Hafsa Sultan Hospital
    • İ̇stanbul
      • Istanbul, İ̇stanbul, Turchia (Türkiye), 34899
        • Marmara Universitesi Pendik Egitim Arastirma Hastanesi

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

12 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Participants ≥18 years of age at Screening in Study B7981040. Adolescents (12 to <18 years of age at Screening in the parent study) are also eligible for this study if approved by the local IRB/EC and regulatory health authority.
  • Participants who met the eligibility criteria and completed 52 weeks of study intervention for stable or active nonsegmental vitiligo in Study B7981040
  • The BL visit/first dose in Study B7981041 must be within 30 days after the week 52 visit in Study B7981040

Exclusion Criteria:

  • Participant met the parent study (Study 7981040) discontinuation criteria or discontinued the parent study for any safety-related event
  • Any active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm 1

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.
Droga: Ritlecitinib

Ritlecitinib 50 mg capsule once daily

Droga: Ritlecitinib 100 mg

Ritlecitinib 100 mg capsule once daily

Droga: Placebo

Matching capsule once daily
Sperimentale: Arm 2

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
Droga: Ritlecitinib

Ritlecitinib 50 mg capsule once daily

Droga: Ritlecitinib 100 mg

Ritlecitinib 100 mg capsule once daily

Droga: Placebo

Matching capsule once daily

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation
Lasso di tempo: Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)

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
Lasso di tempo: Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)

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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Response based on T-VASI75 at weeks 4, 8, 12, 24, 36 and 52
Lasso di tempo: Baseline to week 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
Lasso di tempo: Baseline to week 52

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
Lasso di tempo: Baseline to Week 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
Lasso di tempo: Baseline to week 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
Lasso di tempo: Baseline to week 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
Lasso di tempo: Baseline to week 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
Lasso di tempo: Baseline to week 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
Lasso di tempo: Baseline to week 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
Lasso di tempo: Baseline to week 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
Lasso di tempo: Baseline to week 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
Lasso di tempo: Baseline to week 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
Lasso di tempo: Baseline to week 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
Lasso di tempo: Baseline to week 52

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
Lasso di tempo: Baseline to week 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
Lasso di tempo: Baseline to week 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).
Lasso di tempo: Baseline to week 52

To compare the efficacy of ritlecitinib 100 mg QD, 50 mg QD, and placebo
Baseline to week 52

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Investigatori

  • Direttore dello studio: Pfizer CT.gov Call Center, Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 gennaio 2024

Completamento primario (Stimato)

31 marzo 2027

Completamento dello studio (Stimato)

31 marzo 2027

Date di iscrizione allo studio

Primo inviato

30 novembre 2023

Primo inviato che soddisfa i criteri di controllo qualità

30 novembre 2023

Primo Inserito (Effettivo)

8 dicembre 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • B7981041
  • 2023-505804-42-00 (Identificatore di registro: CTIS (EU))
  • 2023 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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