Ph3 Efficacy, Safety, and Tolerability of Ritlecitinib in Participants with Non Segmental Vitiligo
Research type
Research Study
Full title
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBO CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NON SEGMENTAL VITILIGO
IRAS ID
1007118
Contact name
Tanya Roberts
Contact email
Sponsor organisation
Pfizer Inc.
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Pfizer is sponsoring this research study to compare the effects of the investigational drug Ritlecitinib with a placebo, to find out if Ritlecitinib is better for treating non segmental vitiligo in adults and adolescents.
Vitiligo is a chronic skin disorder characterised by a patchy loss of skin colour. In humans, a biological molecule called melanin is responsible for skin colour and is called the skin pigment. Melanin is produced by certain types of cells in the body called melanocytes. In vitiligo, the skin loses these melanocytes due to complex reactions involving many different biological molecules. Ritlecitinib acts by blocking the activity of some of the biological molecules responsible for the loss of melanocytes. Ritlecitinib has been tested in previous clinical studies and is considered to have an acceptable safety profile.
There are currently no approved medications taken by mouth to treat non segmental vitiligo. Current treatment options are limited and may be cumbersome to apply on a large body area, unsuccessful or undesirable due to side effects or a need for frequent clinical visits.
In this study participants will be randomly assigned to 1 of 2 treatments:
Arm 1: Ritlecitinib 50mg capsules once a day for 52 weeks
Arm 2: Placebo capsules every day for 52 weeks
Participants will have a 66% (2 in 3) chance of receiving Ritlecitinib and a 33% (1 in 3) chance of receiving the placebo. There will be a screening period of up to 4 weeks, and a follow-up period of 4 weeks. Participants will undergo various tests and procedures such as: hearing tests, biopsy, blood tests, x-ray, ECG and photographs of the affected areas.
About 600 participants will take part in the study globally, with approximately 9 participants from 3 sites within the UK.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
23/EE/0074
Date of REC Opinion
30 Aug 2023
REC opinion
Further Information Favourable Opinion