B7451015_Phase 3 Extension study in subject with Atopic Dermatitis

• Research type

  Research Study

• Full title

  A PHASE 3 MULTI-CENTER, LONG-TERM EXTENSION STUDY INVESTIGATING THE EFFICACY AND SAFETY OF ABROCITINIB, WITH OR WITHOUT TOPICAL MEDICATIONS, ADMINISTERED TO SUBJECTS AGED 12 YEARS AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS

• IRAS ID

  245315

• Contact name

  Michael Cork

• Contact email

  m.j.cork@sheffield.co.uk

• Sponsor organisation

  Pfizer Inc., 235 East 42nd Street, New York, NY 10017

• Eudract number

  2017-004851-22

• Clinicaltrials.gov Identifier

  NCT03422822

• Duration of Study in the UK

  2 years, 8 months, 4 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 evaluate the long term safety and effectiveness of the investigational drug PF-04965842 in participants who previously participated in PF‑04965842 AD Phase 3 studies.

  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 the 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 will come from qualifying AD phase 3 studies and will receive either 100mg or 200mg of PF-04965842 once per day.

  There may be approximately 1260 participants enrolled in this study across 400 research sites in approximately 26 countries.

  The length of this study will depend on the length of the qualifying study the patient comes from.
  All participants will receive the treatment for approximately 104 weeks in total, when combining the two studies.

  Various blood tests, physiological tests, diary entries and questionnaires will be asked of the participant throughout the trial.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  18/NE/0312

• Date of REC Opinion

  8 Nov 2018

• REC opinion

  Further Information Favourable Opinion