A Study to Determine the Safety of PF-04965842 in Atopic Dermatitis
Research type
Research Study
Full title
A Phase 3 Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group, Multi-Center Study Investigating the Efficacy and Safety of PF-04965842 and Dupilumab in Comparison with Placebo in Adult Subjects on Background Topical Therapy, with Moderate to Severe Atopic Dermatitis
IRAS ID
252519
Contact name
Andrew Edward Pink
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2018-002573-21
Clinicaltrials.gov Identifier
123554, IND Number
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
PF-04965842 is a study drug that has not been approved for use in the UK. PF-04965842 blocks a substance produced in the body that may be the cause of atopic dermatitis (AD).
The current study is a Phase 3 study to investigate the study drug PF-04965842 in adult participants who have moderate to severe AD. Two different doses s of PF-04965842, 100 mg and 200 mg taken will be tested to see how efficient they are in combating AD. The study drug is an oral preparation that needs to be taken once daily.
The study drug will also be compared to placebo (a dummy drug) over 12 weeks. Both doses of the study drug will also be compared with dupilumab, to see which drug is better at relieving pruritus (itchy skin) over a period of at 2 weeks and then 16 weeks Participants will use non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, as per protocol guidance, to treat active lesions during the study.
Participants who are randomised to receive one of the two doses of PF-04965842 will also receive placebo injectable study drug every two weeks until Week 16 and then will continue on receiving only the oral study drug for 4 weeks.
Participants who are randomised to receive dupilumab injections every two weeks will also receive oral placebo to be taken once daily until Week 16 and will then continue to receive only the oral placebo for 4 weeks.
Participants who are randomised to the placebo arms, will receive both daily oral placebo and injectable placebo every two weeks until Week 16, after which they will receive either 100 mg or 200 mg of PF-04965842 taken orally once daily for 4 weeks, dependent upon which arm they have been allocated to.
Eligible Participants will have an option to enter a long-term extension study after completing 20 weeks of treatment.Participants will be in this study for up to 28 weeks or 6.5 months (which includes screening and follow-up visits). Approximately 700 adults, aged 18 years or older, will be enrolled in this study. The study is being conducted at about 180 different research sites around the world.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
18/EE/0405
Date of REC Opinion
17 Apr 2019
REC opinion
Further Information Favourable Opinion