Efficacy, safety and tolerability of ritlecitinib 50 & 100 mg in subjects with nonsegmental vitiligo
Research type
Research Study
Full title
A Phase 3 Randomized, Double-Blind, 52-Week Placebo-Controlled Multi-Center Study with A Double-Blind 52-Week Extension Period with Randomized Dose Up/Dose Down Titration Investigating the Efficacy, Safety, and Tolerability of Ritlecitinib in Adult Participants with Nonsegmental Vitiligo
IRAS ID
1008612
Contact name
Adam Schayowitz
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2022-502518-98
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 nonsegmental vitiligo in adults.
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 nonsegmental vitiligo. Current treatment options are limited, unsuccessful or undesirable due to side effects or a need for frequent clinical visits.
The study will be conducted globally, approx 1000 participants in part 1 and approx 450 participants in Part II. Approx 33 participants from 6 sites will be enrolled within the UK.
In this study participants will be randomly assigned to 1 of 3 treatments:
•Part I where two different doses of ritlecitinib (50 mg and 100 mg), taken once daily, will be compared to placebo; and,
•Part II where only ritlecitinib 100 mg will be investigated.
In Part I, participants will have a 60% (3 in 5) chance of receiving ritlecitinib at the 100 mg dose, a 20% (1 in 5) chance of receiving ritlecitinib at the 50 mg dose; and a 20% (1 in 5) chance of receiving the placebo.
There will be a screening period of 30 days, treatment period of 104 weeks for Part I / 52 weeks for Part II with a follow-up period of 4 weeks. Participants will undergo various tests and procedures.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
23/SC/0429
Date of REC Opinion
25 Jan 2024
REC opinion
Further Information Favourable Opinion