이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

비분절성 백반증 환자를 대상으로 리틀레시티닙의 안전성과 효과를 알아보기 위한 52주 연구 (Tranquillo LTE)

2026년 9월 24일 업데이트: Pfizer

비분절성 백반증이 있는 성인 및 청소년 환자를 대상으로 RITLECITINIB의 안전성, 유효성 및 내약성을 조사하는 3상 무작위 중단 및 용량 증량 적정, 다기관 확장 연구

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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

394

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

12년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: Ritlecitinib

Ritlecitinib 50 mg capsule once daily

의약품: Ritlecitinib 100 mg

Ritlecitinib 100 mg capsule once daily

의약품: Placebo

Matching capsule once daily
실험적: 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
의약품: Ritlecitinib

Ritlecitinib 50 mg capsule once daily

의약품: Ritlecitinib 100 mg

Ritlecitinib 100 mg capsule once daily

의약품: Placebo

Matching capsule once daily

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation
기간: 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
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Response based on T-VASI75 at weeks 4, 8, 12, 24, 36 and 52
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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).
기간: Baseline to week 52

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

수사관

  • 연구 책임자: Pfizer CT.gov Call Center, Pfizer

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 1월 19일

기본 완료 (추정된)

2027년 3월 31일

연구 완료 (추정된)

2027년 3월 31일

연구 등록 날짜

최초 제출

2023년 11월 30일

QC 기준을 충족하는 최초 제출

2023년 11월 30일

처음 게시됨 (실제)

2023년 12월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 24일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • B7981041
  • 2023-505804-42-00 (레지스트리 식별자: CTIS (EU))
  • 2023 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다