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Een onderzoek van 52 weken om meer te weten te komen over de veiligheid en effecten van ritlecitinib bij deelnemers met niet-segmentale vitiligo (Tranquillo LTE)

24 september 2026 bijgewerkt door: Pfizer

EEN FASE 3 GErandomiseerde onthoudings- en dosistitratie, multi-center uitbreidingsonderzoek waarin de veiligheid, werkzaamheid en verdraagbaarheid van RITLECITINIB BIJ VOLWASSEN EN ADOLESCENTE DEELNEMERS MET NONSEGMENTALE VITILIGO ONDERZOEKEN

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

394

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Australië
    • New South Wales
      • Darlinghurst, New South Wales, Australië, 2010
        • The Skin Hospital
    • South Australia
      • Campbelltown, South Australia, Australië, 5074
        • North Eastern Health Specialists
    • Victoria
      • Carlton, Victoria, Australië, 3053
        • Skin Health Institute Inc.
      • East Melbourne, Victoria, Australië, 3002
        • Dr Rodney Sinclair Pty Ltd
      • Melbourne, Victoria, Australië, 3004
        • The Alfred Hospital
  • Bulgarije
      • Stara Zagora, Bulgarije, 6003
        • UMHAT "Prof. Dr. Stoyan Kirkovich"AD
    • Kyustendil
      • Dupnitsa, Kyustendil, Bulgarije, 2600
        • Medical Centre "Asklepiy"
    • Sofia (stolitsa)
      • Sofia, Sofia (stolitsa), Bulgarije, 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
  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510091
        • Dermatology Hospital of Southern Medical University
    • Hubei
      • Wuhan, Hubei, China, 430022
        • The First Hospital of Wuhan
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University/Dermatology and STD Department
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Huashan Hospital Fudan University
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • First Affiliated Hospital of Kunming Medical University
  • Duitsland
    • Baden-Wurttemberg
      • Stuttgart, Baden-Wurttemberg, Duitsland, 70178
        • Praxis Leitz und Kollegen
    • Lower Saxony
      • Bad Bentheim, Lower Saxony, Duitsland, 48455
        • Fachklinik Bad Bentheim
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Duitsland, 48149
        • Universitätsklinikum Münster
  • 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
  • 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
  • Spanje
      • Córdoba, Spanje, 14001
        • AUDIKA
    • Andalusia
      • Córdoba, Andalusia, Spanje, 14004
        • Hospital Universitario Reina Sofia
    • Catalunya [cataluña]
      • Barcelona, Catalunya [cataluña], Spanje, 08036
        • Hospital Clínic de Barcelona
    • LAS Palmas
      • Las Palmas de Gran Canaria, LAS Palmas, Spanje, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrín
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spanje, 28034
        • Hospital Universitario Ramón y Cajal
  • Turkije (Türkiye)
      • Istanbul, Turkije (Türkiye), 34098
        • Istanbul Universitesi Cerrahpasa
      • Kayseri, Turkije (Türkiye)
        • Erciyes Universitesi Tıp Fakultesi Hastaneleri
      • Manisa, Turkije (Türkiye), 45030
        • Celal Bayar University Hafsa Sultan Hospital
    • İ̇stanbul
      • Istanbul, İ̇stanbul, Turkije (Türkiye), 34899
        • Marmara Universitesi Pendik Egitim Arastirma Hastanesi
  • Verenigd Koninkrijk
      • London, Verenigd Koninkrijk, SE1 9RT
        • Guy's & St Thomas' NHS Foundation Trust
  • Verenigde Staten
    • California
      • Encinitas, California, Verenigde Staten, 92024
        • California Dermatology & Clinical Research Institute
      • Huntington Beach, California, Verenigde Staten, 92647
        • Marvel Clinical Research
      • Los Angeles, California, Verenigde Staten, 90056
        • Wallace Medical Group, Inc
    • Florida
      • Boynton Beach, Florida, Verenigde Staten, 33436
        • Encore Medical Research of Boynton Beach
      • Hollywood, Florida, Verenigde Staten, 33021
        • Skin Care Research
      • Tampa, Florida, Verenigde Staten, 33613
        • ForCare Clinical Research
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46250
        • Dawes Fretzin Clinical Research Group, LLC
    • Louisiana
      • Baton Rouge, Louisiana, Verenigde Staten, 70809
        • DelRicht Research
    • Maryland
      • Rockville, Maryland, Verenigde Staten, 20850
        • Lawrence J. Green, MD LLC
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
        • University of Michigan
    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten, 87102
        • University of New Mexico Health Sciences Center
    • New York
      • Brooklyn, New York, Verenigde Staten, 11203
        • SUNY Downstate Health Sciences University
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27516
        • University of North Carolina Medical Center
      • Chapel Hill, North Carolina, Verenigde Staten, 27599
        • Clinical & Translational Research Center (CTRC)
      • Wilmington, North Carolina, Verenigde Staten, 28411
        • Accellacare - Wilmington
      • Wilmington, North Carolina, Verenigde Staten, 28411
        • Wilmington Health, PLLC
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44106
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, Verenigde Staten, 43215
        • Remington-Davis, Inc
    • South Carolina
      • Charleston, South Carolina, Verenigde Staten, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, Verenigde Staten, 75231
        • Modern Research Associates, PLLC
      • Houston, Texas, Verenigde Staten, 77056
        • Austin Institute for Clinical Research
      • Houston, Texas, Verenigde Staten, 77008
        • Alpesh D. Desai, DO PLLC
  • Zuid -Korea
    • Kyǒnggi-do
      • Suwon, Kyǒnggi-do, Zuid -Korea, 16247
        • The Catholic University Of Korea St. Vincent's Hospital
      • Suwon, Kyǒnggi-do, Zuid -Korea, 16499
        • Ajou University Hospital
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], Zuid -Korea, 03722
        • Severance Hospital, Yonsei University Health System

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

12 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Ritlecitinib

Ritlecitinib 50 mg capsule once daily

Geneesmiddel: Ritlecitinib 100 mg

Ritlecitinib 100 mg capsule once daily

Geneesmiddel: Placebo

Matching capsule once daily
Experimenteel: 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
Geneesmiddel: Ritlecitinib

Ritlecitinib 50 mg capsule once daily

Geneesmiddel: Ritlecitinib 100 mg

Ritlecitinib 100 mg capsule once daily

Geneesmiddel: Placebo

Matching capsule once daily

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Response based on T-VASI75 at weeks 4, 8, 12, 24, 36 and 52
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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).
Tijdsspanne: Baseline to week 52

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Pfizer

Onderzoekers

  • Studie directeur: Pfizer CT.gov Call Center, Pfizer

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 januari 2024

Primaire voltooiing (Geschat)

31 maart 2027

Studie voltooiing (Geschat)

31 maart 2027

Studieregistratiedata

Eerst ingediend

30 november 2023

Eerst ingediend dat voldeed aan de QC-criteria

30 november 2023

Eerst geplaatst (Werkelijk)

8 december 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 september 2026

Laatste update ingediend die voldeed aan QC-criteria

24 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • B7981041
  • 2023-505804-42-00 (Register-ID: CTIS (EU))
  • 2023 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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