A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata
Research type
Research Study
Full title
A PHASE 3, EXTERNAL AND SYNTHETIC PLACEBO‑CONTROLLED RANDOMIZED STUDY WITH DOSE-UP FOR NON-RESPONDERS TO INVESTIGATE SAFETY AND EFFICACY OF RITLECITINIB 50 MG AND 100 MG ONCE DAILY IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH ALOPECIA AREATA
IRAS ID
1011673
Contact name
Sarah Scheltwort
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2024-519370-40
Clinicaltrials.gov Identifier
Research summary
Pfizer is sponsoring this research study to learn about the safety and effects of ritlecitinib for the treatment of alopecia areata. Alopecia areata is an autoimmune disease that causes hair loss on the scalp, face, and areas of the body. Ritlecitinib acts by preventing the immune system from mistakenly attacking hair follicles.
Ritlecitinib is approved in many countries at a dose of 50 mg (milligram) taken by mouth once a day for the treatment of patients 12 years and older with severe alopecia areata. This study will look at both the 50 mg dose and a 100 mg dose (called study drug). The 100 mg dose will be compared to the 50 mg dose. The 2 doses of study drug will also be compared to data from previous studies. The data from this study will be used to find out if the 100 mg once daily dose is safe and can help patients with alopecia areata regrow hair.
In this study about 550 participants will be randomly assigned to 1 of 2 treatments:
Arm 1 (about 200 participants): Ritlecitinib 100 mg capsules once a day for 48 weeks.
Arm 2 (about 350 participants): Ritlecitinib 50 mg capsules once a day for 24 weeks. Depending on whether a participant has less than or equal to 20% hair loss at week 24, they may be re-randomized to either the 50 mg or 100 mg dose for the second 24 weeks.
Participants who meet the study requirements will take 2 capsules of the study drug each day. One of the capsules will contain one of the doses of study drug. The second capsule will contain placebo that looks like the other dose of study drug but does not have any active drug in it. No participant will be randomized to receive only placebo.
Participants will be in this study for about 13 months and will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as: alopecia areata assessments, hearing tests, blood tests, x-ray, ECG (electrocardiogram) and photographs of the scalp and eyes.REC name
Wales REC 5
REC reference
25/WA/0143
Date of REC Opinion
29 Aug 2025
REC opinion
Further Information Favourable Opinion