B7981028 ALLEGRETTO- LTE
Research type
Research Study
Full title
A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031
IRAS ID
1012296
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 long-term safety and long-term 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:
• previously completed one of Pfizer’s pediatric studies for Alopecia Areata (B7981027 or B7981031).
• documented evidence of having received varicella vaccination (2 doses), or evidence of prior exposure to varicella zoster virus based on blood test.
As the Study B7981031 was not conducted in the UK, the study participants in the Study B7981028 will include only those who previously completed the Study B7981027.
All participants in this study will receive ritlecitinib 50 mg or 30 mg.
Participants who received ritlecitinib 50 mg and 30 mg in the parent Study B7981027 will continue receiving the same ritlecitinib doses respectively, in this trial.
Participants who received placebo in the parent Study B7981027 will be randomized at a 1:1 ratio to receive ritlecitinib 50 mg or 30 mg in this trial.
The study medicine is a capsule that is taken by mouth. It is taken 1 time each day at home.
Participants will take part in this study for a duration of up to 3 years (36 months). During this time, they will have 17 study visits at the study clinic. At these study visits, the participants will be monitored for safety and effects of ritlecitinib. The study team will also call participants once a month over the phone.
The participants will be evaluated at Months 3, 6, 9 and 12 to determine if they can continue in this trial.REC name
London - Central Research Ethics Committee
REC reference
25/LO/0560
Date of REC Opinion
29 Sep 2025
REC opinion
Further Information Favourable Opinion