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En 52-ugers undersøgelse for at lære om sikkerheden og virkningerne af ritlecitinib hos deltagere med ikke-segmentel vitiligo (Tranquillo LTE)

24. september 2026 opdateret af: Pfizer

ET FASE 3 RANDOMISERET TILBAGETRÆKNING OG DOSE-UP TITRATION, MULTI-CENTER UDVIDELSESUNDERSØGELSE, DER UNDERSØGER SIKKERHED, EFFEKTIVITET OG TOLERABILITET AF RITLECITINIB HOS VOKSNE OG UNGE DELTAGERE MED VILIGO NONSEGMENT

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

394

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Ritlecitinib

Ritlecitinib 50 mg capsule once daily

Medicin: Ritlecitinib 100 mg

Ritlecitinib 100 mg capsule once daily

Medicin: Placebo

Matching capsule once daily
Eksperimentel: 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
Medicin: Ritlecitinib

Ritlecitinib 50 mg capsule once daily

Medicin: Ritlecitinib 100 mg

Ritlecitinib 100 mg capsule once daily

Medicin: Placebo

Matching capsule once daily

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Response based on T-VASI75 at weeks 4, 8, 12, 24, 36 and 52
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).
Tidsramme: Baseline to week 52

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Efterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. januar 2024

Primær færdiggørelse (Anslået)

31. marts 2027

Studieafslutning (Anslået)

31. marts 2027

Datoer for studieregistrering

Først indsendt

30. november 2023

Først indsendt, der opfyldte QC-kriterier

30. november 2023

Først opslået (Faktiske)

8. december 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B7981041
  • 2023-505804-42-00 (Registry Identifier: CTIS (EU))
  • 2023 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner