A PHASE 3 RANDOMIZED WITHDRAWAL AND DOSE-UP TITRATION, MULTICENTER EXTENSION STUDY INVESTIGATING THE SAFETY, EFFICACY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO

Status: Recruiting
Location: See all (74) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
United States
California
California Dermatology & Clinical Research Institute
RECRUITING
Encinitas
Marvel Clinical Research
RECRUITING
Huntington Beach
Wallace Medical Group, Inc
RECRUITING
Los Angeles
Florida
Encore Medical Research of Boynton Beach
RECRUITING
Boynton Beach
Skin Care Research
RECRUITING
Hollywood
ForCare Clinical Research
RECRUITING
Tampa
Indiana
Dawes Fretzin Clinical Research Group, LLC
RECRUITING
Indianapolis
Louisiana
DelRicht Research
ACTIVE_NOT_RECRUITING
Baton Rouge
Maryland
Lawrence J. Green, MD LLC
RECRUITING
Rockville
Michigan
University of Michigan
RECRUITING
Ann Arbor
North Carolina
Clinical & Translational Research Center (CTRC)
RECRUITING
Chapel Hill
University of North Carolina Medical Center
RECRUITING
Chapel Hill
Accellacare - Wilmington
RECRUITING
Wilmington
Wilmington Health, PLLC
RECRUITING
Wilmington
New Mexico
University of New Mexico Health Sciences Center
RECRUITING
Albuquerque
New York
SUNY Downstate Health Sciences University
RECRUITING
Brooklyn
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Remington-Davis, Inc
RECRUITING
Columbus
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
Modern Research Associates, PLLC
RECRUITING
Dallas
Alpesh D. Desai, DO PLLC
ACTIVE_NOT_RECRUITING
Houston
Austin Institute for Clinical Research
RECRUITING
Houston
Other Locations
Australia
North Eastern Health Specialists
RECRUITING
Campbelltown
Skin Health Institute Inc.
RECRUITING
Carlton
The Skin Hospital
RECRUITING
Darlinghurst
Dr Rodney Sinclair Pty Ltd
RECRUITING
East Melbourne
The Alfred Hospital
RECRUITING
Melbourne
Bulgaria
Medical Centre Asklepiy
RECRUITING
Dupnitsa
Diagnostic Consultative Center Aleksandrovska
RECRUITING
Sofia
UMHAT Prof. Dr. Stoyan KirkovichAD
RECRUITING
Stara Zagora
Canada
Dermatology Research Institute
ACTIVE_NOT_RECRUITING
Calgary
Lynderm Research Inc.
RECRUITING
Markham
DermEdge Research
RECRUITING
Mississauga
Centre de Recherche Dermatologique du Quebec metropolitain
ACTIVE_NOT_RECRUITING
Québec
Centre de Recherche Saint-Louis inc.
ACTIVE_NOT_RECRUITING
Québec
CaRe Clinic
ACTIVE_NOT_RECRUITING
Red Deer
North York Research Inc
RECRUITING
Toronto
China
Dermatology Hospital of Southern Medical University
RECRUITING
Guangzhou
Guangzhou First People's Hospital
NOT_YET_RECRUITING
Guangzhou
First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
Huashan Hospital Fudan University
RECRUITING
Shanghai
The First Hospital of China Medical University/Dermatology and STD Department
RECRUITING
Shenyang
The First Hospital of Wuhan
RECRUITING
Wuhan
Germany
Fachklinik Bad Bentheim
RECRUITING
Bad Bentheim
Universitätsklinikum Münster
RECRUITING
Münster
Praxis Leitz und Kollegen
RECRUITING
Stuttgart
Japan
Nippon Medical School Hospital
ACTIVE_NOT_RECRUITING
Bunkyo-ku
Yamanashi Prefectural Central Hospital
ACTIVE_NOT_RECRUITING
Kofu
Nagoya City University Hospital
ACTIVE_NOT_RECRUITING
Nagoya
Dermatology and Ophthalmology Kume Clinic
ACTIVE_NOT_RECRUITING
Sakai
Tohoku University Hospital
ACTIVE_NOT_RECRUITING
Sendai
Tokyo Medical University Hospital
ACTIVE_NOT_RECRUITING
Shinjuku-ku
Mexico
Hospital Infantil de Mexico Federico Gomez
RECRUITING
Mexico City
Centro de Dermatologia de Monterrey
RECRUITING
Monterrey
Arké SMO S.A de C.V
RECRUITING
Veracruz
Sociedad de Metabolismo y Corazon S.C.
RECRUITING
Veracruz
Poland
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
RECRUITING
Lodz
DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
RECRUITING
Osielsko
Dermedic Jacek Zdybski
RECRUITING
Ostrowiec Świętokrzyski
Twoja Przychodnia SCM
RECRUITING
Szczecin
Royalderm Agnieszka Nawrocka
RECRUITING
Warsaw
Republic of Korea
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
The Catholic University Of Korea St. Vincent's Hospital
RECRUITING
Suwon
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
AUDIKA
RECRUITING
Córdoba
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Hospital Universitario de Gran Canaria Doctor Negrín
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Turkey
Marmara Universitesi Pendik Egitim Arastirma Hastanesi
RECRUITING
Istanbul
Istanbul Universitesi Cerrahpasa
RECRUITING
Istanbul- Fatih
Erciyes Universitesi Tıp Fakultesi Hastaneleri
RECRUITING
Kayseri
Celal Bayar University Hafsa Sultan Hospital
RECRUITING
Manisa
United Kingdom
Guy's & St Thomas' NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2024-01-19
Estimated Completion Date: 2027-04-23
Participants
Target number of participants: 400
Treatments
Experimental: 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.
Experimental: 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
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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