A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo

Last updated: December 2, 2024
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Vitiligo

Treatment

Ritlecitinib

Placebo

Ritlecitinib 100 mg

Clinical Study ID

NCT06163326
B7981041
2023-505804-42-00
  • Ages > 12
  • All Genders

Study Summary

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. At week 4 (or if it cannot be done then, at week 8) study visit, 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants ≥18 years of age at Screening in Study B7981040. Adolescents (12 to <18years of age at Screening in the parent study) are also eligible for this study ifapproved by the local IRB/EC and regulatory health authority.

  • Participants who met the eligibility criteria and completed 52 weeks of studyintervention 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 52visit in Study B7981040

Exclusion

Exclusion Criteria:

  • Participant met the parent study (Study 7981040) discontinuation criteria ordiscontinued the parent study for any safety-related event

  • Any active suicidal ideation/behavior or laboratory abnormality that may increasethe risk of study participation

Study Design

Total Participants: 400
Treatment Group(s): 3
Primary Treatment: Ritlecitinib
Phase: 3
Study Start date:
January 19, 2024
Estimated Completion Date:
January 30, 2027

Connect with a study center

  • North Eastern Health Specialists

    Campbelltown, South Australia 5074
    Australia

    Site Not Available

  • Skin Health Institute Inc.

    Carlton, Victoria 3053
    Australia

    Active - Recruiting

  • Dr Rodney Sinclair Pty Ltd

    East Melbourne, Victoria 3002
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Medical Centre "Asklepiy"

    Dupnitsa, Kyustendil 2600
    Bulgaria

    Active - Recruiting

  • Diagnostic Consultative Center Aleksandrovska

    Sofia, Sofia (stolitsa) 1431
    Bulgaria

    Site Not Available

  • UMHAT "Prof. Dr. Stoyan Kirkovich"AD

    Stara Zagora, 6003
    Bulgaria

    Active - Recruiting

  • Dermatology Research Institute

    Calgary, Alberta T2J 7E1
    Canada

    Active - Recruiting

  • CARe Clinic

    Red Deer, Alberta T4P 1K4
    Canada

    Active - Recruiting

  • Lynderm Research Inc.

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • DermEdge Research

    Mississauga, Ontario L4Y 4C5
    Canada

    Site Not Available

  • North York Research Inc

    Toronto, Ontario M2N3A6
    Canada

    Active - Recruiting

  • Centre de Recherche Dermatologique du Quebec metropolitain

    Quebec, G1V 4X7
    Canada

    Active - Recruiting

  • Centre de Recherche Saint-Louis

    Quebec, G1W 4R4
    Canada

    Active - Recruiting

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Site Not Available

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong 510091
    China

    Active - Recruiting

  • Guangdong Province Dermatology Hospital

    Guangzhou, Guangdong
    China

    Site Not Available

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong 510180
    China

    Site Not Available

  • The First Hospital of Wuhan

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • The First Hospital of China Medical University/Dermatology and STD Department

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • Huashan Hospital Fudan University

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Active - Recruiting

  • Praxis Leitz und Kollegen

    Stuttgart, Baden-württemberg 70178
    Germany

    Active - Recruiting

  • Fachklinik Bad Bentheim

    Bad Bentheim, Niedersachsen 48455
    Germany

    Active - Recruiting

  • Universitätsklinikum Münster

    Münster, Nordrhein-westfalen 48149
    Germany

    Active - Recruiting

  • Nagoya City University Hospital

    Nagoya, Aichi 467-8602
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai, Miyagi 980-8574
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai-shi, Miyagi 980-8574
    Japan

    Site Not Available

  • Dermatology and Ophthalmology Kume Clinic

    Sakai, Osaka 593-8324
    Japan

    Active - Recruiting

  • Dermatology and Ophthalmology Kume Clinic

    Sakai City, Osaka 593-8324
    Japan

    Site Not Available

  • Dermatology and Ophthalmology Kume Clinic

    Sakai-City, Osaka 593-8324
    Japan

    Site Not Available

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo 113-8603
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • Yamanashi Prefectural Central Hospital

    Kofu, Yamanashi 400-8506
    Japan

    Active - Recruiting

  • Nippon Medical School Hospital

    Tokyo, 113-8603
    Japan

    Active - Recruiting

  • Ajou University Hospital

    Suwon, Kyǒnggi-do 16499
    Korea, Republic of

    Active - Recruiting

  • The Catholic University Of Korea St. Vincent's Hospital

    Suwon-si, Kyǒnggi-do 16247
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul] 03722
    Korea, Republic of

    Active - Recruiting

  • Centro de Dermatologia de Monterrey

    Monterrey, Nuevo LEÓN 64460
    Mexico

    Site Not Available

  • Sociedad de Metabolismo y Corazon S.C.

    Veracruz, 91900
    Mexico

    Site Not Available

  • DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.

    Osielsko, Kujawsko-pomorskie 86-031
    Poland

    Active - Recruiting

  • Royalderm Agnieszka Nawrocka

    Warszawa, Mazowieckie 02-962
    Poland

    Active - Recruiting

  • Twoja Przychodnia SCM

    Szczecin, Zachodniopomorskie 71-500
    Poland

    Active - Recruiting

  • Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak

    Lodz, Łódzkie 90-436
    Poland

    Active - Recruiting

  • Dermedic Jacek Zdybski

    Ostrowiec Swietokrzyski, Świętokrzyskie 27-400
    Poland

    Active - Recruiting

  • Hospital Universitario Reina Sofia

    Cordoba, Andalucía 14004
    Spain

    Active - Recruiting

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [cataluña] 08036
    Spain

    Active - Recruiting

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria, LAS Palmas 35010
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad DE 28034
    Spain

    Active - Recruiting

  • AUDIKA

    Córdoba, 14001
    Spain

    Active - Recruiting

  • Marmara Universitesi Pendik Egitim Arastirma Hastanesi

    Istanbul, 34899
    Turkey

    Site Not Available

  • Erciyes Universitesi Tıp Fakultesi Hastaneleri

    Kayseri,
    Turkey

    Site Not Available

  • Celal Bayar University Hafsa Sultan Hospital

    Manisa, 45030
    Turkey

    Site Not Available

  • California Dermatology & Clinical Research Institute

    Encinitas, California 92024
    United States

    Active - Recruiting

  • Marvel Clinical Research

    Huntington Beach, California 92647
    United States

    Active - Recruiting

  • Wallace Medical Group, Inc

    Los Angeles, California 90056
    United States

    Active - Recruiting

  • Encore Medical Research of Boynton Beach

    Boynton Beach, Florida 33436
    United States

    Active - Recruiting

  • Skin Care Research

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • ForCare Clinical Research

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • DelRicht Research

    Baton Rouge, Louisiana 70809
    United States

    Active - Recruiting

  • Visage Dermatology and Aesthetic Center

    Largo, Maryland 20774
    United States

    Site Not Available

  • Lawrence J. Green, MD LLC

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • SUNY Downstate Health Sciences University

    Brooklyn, New York 11203
    United States

    Active - Recruiting

  • Clinical & Translational Research Center (CTRC)

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina 27516
    United States

    Active - Recruiting

  • Accellacare - Wilmington

    Wilmington, North Carolina 28411
    United States

    Active - Recruiting

  • Wilmington Health, PLLC

    Wilmington, North Carolina 28411
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Remington Davis Clinical Research

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • Remington-Davis, Inc

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Modern Research Associates, PLLC

    Dallas, Texas 75231
    United States

    Site Not Available

  • Alpesh D. Desai, DO PLLC

    Houston, Texas 77008
    United States

    Site Not Available

  • Austin Institute for Clinical Research

    Houston, Texas 77056
    United States

    Active - Recruiting

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

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