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Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa

Trial Profile

Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa

Recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Dec 2018

At a glance

  • Drugs Oleogel S10 (Primary)
  • Indications Epidermolysis bullosa
  • Focus Therapeutic Use
  • Acronyms EASE
  • Sponsors Amryt Pharma
  • Most Recent Events

    • 07 Nov 2018 Planned primary completion date changed from 1 Sep 2018 to 1 Dec 2018.
    • 10 Sep 2018 According to an Amryt Pharma media release, the company has received the US FDA clearance for an Investigational New Drug (IND) for AP-101 to open the clinical sites in USA for this study.
    • 02 Aug 2018 According to an Amryt Pharma media release, an interim efficacy data readout is expected in later 2018 and the top-line data readout is expected in Q2 2019.
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