ORAL ZPL3893787 ON PRURITUS IN ADULTS WITH ATOPIC DERMATITIS

• Research type

  Research Study

• Full title

  A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE EFFECTS OF 8 WEEKS TREATMENT WITH ORAL ZPL-3893787 (30 MG OD X 56 DAYS) ON PRURITUS IN ADULT SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS.

• IRAS ID

  170493

• Contact name

  Aliya Asher

• Contact email

  aliyaasher@macplc.com

• Sponsor organisation

  Ziarco Pharma Ltd

• Eudract number

  2014-005057-39

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  The aim of this study is to assess the effects of the study compound on the severity of itch in subjects with atopic dermatitis compared to placebo (a sugar pill), every day for 8 weeks. Also the aim is to assess the safety and tolerability of the compound and how it affects the subjects, the effects of the compound on the severity of the skin lesions and how much rescue treatment the subjects need to use.
  Ninety subjects will be recruited and they will receive either the compound or placebo, one capsule in the morning for 56 days. The subjects will attend the site for a follow-up visit, 21-28 days after the last dose.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  15/NW/0187

• Date of REC Opinion

  10 Apr 2015

• REC opinion

  Further Information Favourable Opinion