B7451036 JADE TEEN
Research type
Research Study
Full title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 CO-ADMINISTERED WITH BACKGROUND MEDICATED TOPICAL THERAPY IN ADOLESCENT PARTICIPANTS 12 TO <18 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
IRAS ID
257713
Contact name
Anthony Paul Bewley
Contact email
Sponsor organisation
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eudract number
2018-003804-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 19 days
Research summary
This study is a phase III study for patients aged 12 to <18 with moderate to severe atopic dermatitis (AD), also known as eczema. The purpose of this research study is to compare how safe and effective two doses of the study drug (PF-04965842) are when compared with a placebo, when taken together with medicated and non-medicated therapy applied to the skin. Researchers will compare the results of taking the higher dose, lower dose, and placebo to see if there are any differences, when taken with the background medication. PF-04965842 is a blocker of an enzyme called Janus kinase (JAK), which acts like a switch for the cells of the immune system. By turning off this switch, the cells of the immune system are expected to produce fewer chemicals believed to cause AD.\n\nAD is a common disease in childhood that is a serious burden on patients and their families. Most AD is mild and can be managed with the use of emollients and standard therapy consisting of topical corticosteroids or topical calcineurin inhibitors. However, in a subgroup of patients with moderate to severe AD, the disease is not responding to topical therapy and systemic treatments become necessary.\n\nEligible patients must have a documented history of inadequate response or intolerance to treatment with topical AD medications or have required systemic therapies for control of their disease amongst other eligibility criteria.\n\nThere will be about 225 adolescent aged between 12 to 18 years taking part in this study at about 100 different study sites globally. The study will last for about 20 weeks and participants will need to visit the study site at least 7 times during the study and two telephone calls with the site staff. Blood tests, physiological tests, diary entries and questionnaires will be asked of the participants throughout the trial.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
19/YH/0072
Date of REC Opinion
19 Jul 2019
REC opinion
Further Information Favourable Opinion