Amryt Presents New Analyses from the EASE Phase 3 Trial in Epidermolysis Bullosa at SPD 2022
Retrieved on:
Thursday, July 7, 2022
JEB, Department, FDA, Patient, DEB, SPD, EB, Epidermolysis bullosa, European Commission, Degenerative disease, Ford 4.4 Turbo Diesel, Pain, BSAP, Wound healing, EASE, Clinical trial, Royal commission, University, Colorado School of Public Health, OLP, MD, Junctional epidermolysis bullosa (medicine), Pharmaceutical industry, Medical imaging, Healthcare, EU
EASE ( NCT03068780 ), the largest clinical trial in Epidermolysis Bullosa (EB), is a Phase 3, randomized, controlled, 90-day double-blind, efficacy and safety study of Oleogel-S10 (birch triterpenes) in patients with inherited EB, followed by a 24-month open-label single-arm phase.
Key Points:
- EASE ( NCT03068780 ), the largest clinical trial in Epidermolysis Bullosa (EB), is a Phase 3, randomized, controlled, 90-day double-blind, efficacy and safety study of Oleogel-S10 (birch triterpenes) in patients with inherited EB, followed by a 24-month open-label single-arm phase.
- We are committed to working with other regulatory agencies, including the FDA, to enable more patients to avail of this treatment.
- The proportion of DEB patients with target wound closure within 45 days was 44.3% on Oleogel-S10 versus 29.6% on control gel (p=0.017).
- The EASE trial (NCT03068780) is the largest ever global Phase 3 trial conducted in patients with EB, performed across 58 sites in 28 countries.