B7451012_Phase 3 study in Subjects with moderate to severe Atopic Derm

• Research type

  Research Study

• Full title

  A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04965842 MONOTHERAPY IN SUBJECTS AGED 12 YEARS AND OLDER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS

• IRAS ID

  239572

• Contact name

  Michael Cork

• Contact email

  m.j.cork@sheffield.ac.uk

• Sponsor organisation

  Pfizer Inc.

• Eudract number

  2017-003651-29

• Clinicaltrials.gov Identifier

  NCT03349060

• Clinicaltrials.gov Identifier

  DERM 35824, Registration of Study with NIHR

• Duration of Study in the UK

  0 years, 7 months, 7 days

• Research summary

  This study is a phase III study for patients aged 12 years and older with moderate to severe atopic dermatitis (AD) also known as eczema. The purpose of this study is to compare the investigational drug PF-04965842 with a placebo to find out which is better for treating atopic dermatitis. PF-04965842 is a blocker of an enzyme called Janus kinase, 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 atopic dermatitis.

  Atopic dermatitis 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.

  Eligible 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.

  There will be approximately 375 adults and adolescents (ages 12 to 17 years old) enrolled in this study across 75 research sites in approximately 7 countries. The study will last for about 20 weeks and the participants will need to visit the study site at least 7 times during the study with two additional telephone calls with the site staff. Various blood tests, physiological tests, diary entries and questionnaires will be asked of the participants throughout the trial.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  18/SC/0210

• Date of REC Opinion

  12 Jul 2018

• REC opinion

  Further Information Favourable Opinion