B7981027 ALLEGRETTO
Research type
Research Study
Full title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Ritlecitinib in Pediatric Participants 6 to less than 12 Years of Age With Severe Alopecia Areata.
IRAS ID
1012295
Contact name
Monica Lindsay
Contact email
Sponsor organisation
Pfizer Inc.
Clinicaltrials.gov Identifier
Research summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ritlecitinib) for the potential treatment of severe alopecia areata, a condition that causes hair loss.
This study is seeking participants who have:
- at least 50% scalp hair loss due to alopecia areata.
- documented evidence of having received varicella vaccination (2 doses), or evidence of prior exposure to varicella zoster virus based on blood test.
- history of clinical response failure to alopecia areata treatment (for children in EU/UK only).
All participants in this study will receive either study medicine (ritlecitinib) or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied.
One-third participants will receive ritlecitinib 30mg, one-third participants will receive ritlecitinib 50mg, and one-third participants will receive placebo.
The study medicine is a capsule that is taken by mouth. It is taken 1 time each day at home.
We will compare the experiences of people receiving ritlecitinib to those of the people who do not. This will help us determine if ritlecitinib is safe and effective.
Participants will take part in this study for 6 months. During this time, they will have 8 study visits at the study clinic. The study team will also call participants about 8 times over the phone.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
26/YH/0025
Date of REC Opinion
19 Feb 2026
REC opinion
Favourable Opinion