ZPL389/103

• Research type

  Research Study

• Full title

  A RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP DOSE RANGING STUDY TO DETERMINE THE EFFICACY AND SAFETY OF ONCE DAILY ORAL ZPL-3893787-18 (3 MG, 10 MG AND 30 MG) CAPSULES ADMINISTERED FOR 12 WEEKS IN ADULT SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

• IRAS ID

  219606

• Contact name

  Babatunde Oyesile

• Contact email

  boyesile@medinovaresearch.com

• Sponsor organisation

  Ziarco Pharma Ltd

• Eudract number

  2016-003855-31

• Duration of Study in the UK

  0 years, 11 months, 31 days

• Research summary

  In this randomised, double-blind, placebo controlled, dose ranging study 320 male and female patients with atopic dermatitis and an age range of 18 and above shall be included.\nAtopic dermatitis (AD) is a chronic, relapsing, inflammatory skin condition. It is characterized by poorly defined erythema with oedema, vesiculation, and weeping in the acute stage and skin thickening (lichenification) in the chronic stage (Eichenfield, 2004) (Williams HC, 1994). Topical corticosteroids are the main treatment up to now, but concerns about skin malignancies and increased risk of lymphomas have required a warning regarding the long-term safety of topical tacrolimus and pimecrolimus in their prescribing information.\n\nZPL-3893787-18 is a potent and selective histamine H4 receptor antagonist and has been shown in recent phase 1 and 2a studies to be safe and potent in treating atopic dermatitis. ZPL-3893787 is administered orally. In this study treatment for the patients will last 12 weeks and the study will be conducted at three sites in the UK in Romford, Northwood and Sidcup as well as in sites in Australia, Canada, Germany and the US.\n40 patients will be randomised in the UK.\nThe data of this study are demmed to deliver important information regarding safety and efficacy of ZPL-3893787 and for the development of a new treatment of atopic dermatitis.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  17/NW/0011

• Date of REC Opinion

  23 Jan 2017

• REC opinion

  Favourable Opinion