From: Oleogel-S10 Phase 3 study “EASE” for epidermolysis bullosa: study design and rationale
Primary endpoint | • Proportion of patients with complete closure of the target wound within 45 ± 7 days of treatment |
Secondary endpoints | • Time to wound closure up to 90 ± 7 days of treatment (key secondary endpoint) • Incidence of first complete wound closure of EB target wound at different time points (see Fig. 2) • Change from baseline in EB target wound size • Change in total body wound burden over time • Change in percentages of TBSA affected by EB partial thickness wounds |
Patient-reported outcomes | • Change from baseline in background and procedural pain after wound dressing change • Change from baseline in itching before wound dressing change • Response to treatment • Change from baseline in sleep quality • Number of days missed from school or work |
Safety endpoints | • Incidence, severity, and relatedness of AEs • Local tolerability • Laboratory findings • Incidence and severity of wound infections |