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
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
- 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.