B7981032 - PF-06651600 in Adult with Alopecia Areata
Research type
Research Study
Full title
A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA
IRAS ID
266296
Contact name
Christos Tziotzios
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2019-001084-71
Duration of Study in the UK
3 years, 0 months, 6 days
Research summary
The purpose of this study is to learn about the effects of the study drug (PF-06651600) for treating alopecia areata (chronic hair loss). The study drug (PF-06651600) is an investigational drug because it is not approved for use in the UK.
Participants will be in this study for about 26 months (just over 2 years). This includes up to, a 5 week screening period, a 24 month open-label study drug period, and a 4 week follow up period. Participants will need to visit the study site about 13 times during the study. 860 people will taking part in this study being done at about 120 different study sites in 18 countries. Only Patients 18 years old and older will be considered to participate on this study in the UK.
Participants from B7981015 studies in the UK, can continue treatment on the B7981032 study with the study drug after completing their index study (B7981015). The B7931003 index study is not being done in the UK, so only patients from the B7981015 index study and new (de novo) patients will be recruited on to the B7981032 study in the UK. There is no washout period for patients who took part in the B7981015 study, before taking part in the B7981032 study but all inclusion criteria should be met before joining the B7981032 study.
Participants who participated in the B7981015 reference studies will remain on the 50 mg per day dose. New (de novo) participants will also be recruited onto the B7981032 study and will start on a 200 mg per day for 4 weeks, and then 50 mg of study drug per day for the remainder of the study.
Although this is a global protocol which includes adolescent patients, only patients aged 18+ will be recruited in the UK, as recommended by the EMA scientific advise.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
20/YH/0063
Date of REC Opinion
1 Jun 2020
REC opinion
Further Information Favourable Opinion