Ph3 Withdrawal/Dose-Up Study of Ritlecitinib for Nonsegmental Vitiligo
Research type
Research Study
Full 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
IRAS ID
1009281
Contact name
Jill Lundberg
Contact email
Sponsor organisation
Pfizer Inc.
Clinicaltrials.gov Identifier
Research summary
Pfizer is sponsoring this research study to determine how safe and effective Ritlecitinib is in participants with non-segmental vitiligo (NSV). Vitiligo is a chronic depigmentation(loss of skin color or pigment) disorder characterized by well-defined pale white patches of skin. Ritlecitinib has been tested in previous clinical studies and is considered to have an acceptable safety profile. Ritlecitinib 50 mg is an approved drug for the treatment of severe Alopecia Areata (a disease with similar abnormal changes) in the US, EU and Japan.
NSV is an autoimmune disorder and it is the focus of this study. This study will show:
• if repigmentation achieved in study B7981040 (the“parent study”) will stay the same or will further increase if you keep receiving the same study medicine (ritlecitinib 50 mgs or placebo)
• or if more repigmentation can be achieved if you start receiving ritlecitinib 100 mgs
• or how long the repigmentation achieved during the parent study lasts if you start receiving placebo
This study will enrol participants who have non-segmental vitiligo (either active or stable) and received ritlecitinib or placebo for 52 weeks in the parent study.
Participants will be randomly assigned to Ritlecitinib 50 mg or 100 mg or placebo depending on the treatment they received in the parent study and how they responded to that treatment. Adolescents will not receive 100 mg ritlecitinib in this study.
The study medicine are capsules that are taken by mouth at home every day for 52 weeks.
Maximum study participation is 60 weeks during which they will have 9 study visits (a Screening visit, in some cases a Baseline visit, and around 7 visits after that with gaps of 1-4 months between visits).
About 400 participants will take part in the study globally, with approximately 7 participants from 3 sites within the UK.REC name
West of Scotland REC 1
REC reference
24/WS/0032
Date of REC Opinion
10 Apr 2024
REC opinion
Further Information Favourable Opinion