RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-19
Study Completion:2027-04-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06163326

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Participants who met the eligibility criteria and completed 52 weeks of study intervention for stable or active nonsegmental vitiligo in Study B7981040
  3. * The BL visit/first dose in Study B7981041 must be within 30 days after the week 52 visit in Study B7981040
  1. * Participant met the parent study (Study 7981040) discontinuation criteria or discontinued the parent study for any safety-related event
  2. * Any active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

California Dermatology & Clinical Research Institute
Encinitas, California, 92024
United States
Marvel Clinical Research
Huntington Beach, California, 92647
United States
Wallace Medical Group, Inc
Los Angeles, California, 90056
United States
Encore Medical Research of Boynton Beach
Boynton Beach, Florida, 33436
United States
Skin Care Research
Hollywood, Florida, 33021
United States
ForCare Clinical Research
Tampa, Florida, 33613
United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
United States
DelRicht Research
Baton Rouge, Louisiana, 70809
United States
Lawrence J. Green, MD LLC
Rockville, Maryland, 20850
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87102
United States
SUNY Downstate Health Sciences University
Brooklyn, New York, 11203
United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27516
United States
Clinical & Translational Research Center (CTRC)
Chapel Hill, North Carolina, 27599
United States
Accellacare - Wilmington
Wilmington, North Carolina, 28411
United States
Wilmington Health, PLLC
Wilmington, North Carolina, 28411
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Remington-Davis, Inc
Columbus, Ohio, 43215
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Modern Research Associates, PLLC
Dallas, Texas, 75231
United States
Alpesh D. Desai, DO PLLC
Houston, Texas, 77008
United States
Austin Institute for Clinical Research
Houston, Texas, 77056
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-19
Study Completion Date2027-04-23

Study Record Updates

Study Start Date2024-01-19
Study Completion Date2027-04-23

Terms related to this study

Keywords Provided by Researchers

  • Stable vitiligo
  • Active vitiligo
  • Adults
  • Adolescents

Additional Relevant MeSH Terms

  • Vitiligo