B7981015 - PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA)
Research type
Research Study
Full title
A PHASE 2B/3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA) SUBJECTS WITH 50% OR GREATER SCALP HAIR LOSS
IRAS ID
257273
Contact name
Christos Tziotzios
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2018-001714-14
Clinicaltrials.gov Identifier
131503, US IND
Duration of Study in the UK
1 years, 9 months, 15 days
Research summary
Summary of Research
The purpose of this study is to compare the effects of the study drug (PF-06651600) with a placebo to find out which is better for treating moderate to severe Alopecia Areata (AA). Alopecia areata (AA) is a chronic relapsing T-cell mediated autoimmune disorder characterised by non-scarring hair loss affecting children and adults, of all ages.The study drug (PF 06651600) is an investigational drug because it is not approved for use in the UK or any other country. The placebo looks like the study drug but does not contain any active ingredients (fake drug or sugar pill).
The treatment period will consist of a placebo-controlled period that includes a 4-week loading phase and a 20-week maintenance phase, followed by a 24-week extension phase.
Participants in this study, will be initially assigned by chance (like pulling a number out of a hat) to be enroled into one (1) of seven (7) different treatment groups using different doses of the study drug (PF-06651600) or placebo in the first 24 weeks. Regardless of which treatment group the participants are initially assigned to, all participants will receive study drug (PF-06651600) during the second part of the study (24 weeks extension phase). The chance of being enroled in one of the placebo groups is about 18 out of 100 (or 18.2%). This is a double-blind study meaning that no-one(including the participant, their personal doctor and the study team) can choose the group you will be in, or will know which group the participant is in.
Participants will be in this study for about 53 weeks (just over a full year)and will need to visit the study site about 14 times during the study. There will be about 660 people taking part in this study. The study is being done at about 120 different study sites in 17 countries.
Summary of Ressults:
Efficacy • Ritlecitinib 200/50 mg, 200/30 mg, 50 mg, and 30 mg were significantly superior to placebo on clinician-assessed and patient-reported endpoints.
o Overall efficacy was lower in participants with AT/AU compared with participants with non-AT/AU.
o Overall efficacy was similar in adult and adolescent participants.
• Ritlecitinib 200/50 mg, 200/30 mg, 50 mg, and 30 mg produced significantly higher response rates of scalp hair regrowth and were nominally superior to placebo at Week 24 in producing improvement in eyebrows and eyelashes.
• Continued improvement in efficacy endpoints was seen between Week 24 and Week 48, although this Extension Period was not placebo-controlled.
• Although the Week 24 efficacy of dose regimens with a loading dose was higher than corresponding dose regimens without a loading dose, the Week 48 efficacy of dose regimens with or without a loading dose was comparable.Safety
• Ritlecitinib was safe and well-tolerated in participants treated with ritlecitinib for up to 48 weeks.
• No deaths were reported.
• There were no dose-dependent trends in serious adverse events.
• There were few serious infections and no opportunistic infections. All treatment emergent adverse events of herpes zoster were mild to moderate and occurred in participants treated with ritlecitinib.
• Dose regimens with a 200 mg loading dose had a higher incidence of some side effects (eg, folliculitis, urticaria, dizziness, influenza, upper respiratory tract infection, pruritus, and urinary tract infection) compared to their respective maintenance dose (50 mg or 30 mg).Summary of Results
The new Clinical Study Report Errata v4 approved on 13-Jul-2022 supersedes the previous Clinical Study Report Errata v3 approved on 08-Apr-2022 that was included/submitted in the CSR package described above.This new version includes the following error related to some units erroneously reported as μg/mL rather than g/dL.
These errors did not have any impact on the results/conclusion of the study and didn’t require any further modifications in the Full CSR or Synopsis.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0151
Date of REC Opinion
11 Jul 2019
REC opinion
Further Information Favourable Opinion