A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, ADAPTIVE PHASE III TRIAL TO INVESTIGATE EFFICACY AND SAFETY OF VILOBELIMAB IN THE TREATMENT OF ULCERATIVE PYODERMA GANGRENOSUM

ulcerative pyoderma gangrenosum

Proportion of patients achieving complete closure of the target ulcer up to and including EOT visit; where complete closure of the target ulcer is assessed by the investigator as complete re-epithelization (defined as wound covered by epithelial skin layer or scar) without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart.

Proportion of patients achieving disease remission up to and including EOT visit; where disease remission is assessed by the investigator as complete re-epithelization (defined as wound covered by epithelial skin layer or scar) of all PG ulcers, without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart., Proportion of patients achieving a pain reduction related to the target ulcer of at least 3 points compared to baseline or reaching 0, at any time between Week 10 and EOT visit inclusively (measured by the 0-10 numeric rating scale (NRS))., Proportion of patients achieving a target ulcer volume reduction of 50% or more compared to baseline, at End of Treatment visit, assessed by the investigator and supported by standardized photographic documentation, Proportion of patients achieving a pain reduction related to the target ulcer of at least 2 points compared to baseline or reaching 0, at any time between Week 10 and EOT visit inclusively (measured by the 0-10 NRS)., Maximum absolute decrease in target ulcer pain from baseline at any time up to and including EOT visit (assessed by patients on the 0-10 NRS), Absolute change in target ulcer pain from baseline at Week 10, 18, and 26 (assessed by patients on the 0-10 NRS), Maximum reduction of the target ulcer volume by EOT visit compared to baseline., Time to first detected complete closure of the target ulcer; where complete closure of target ulcer is assessed by the investigator as complete re-epithelization (defined as wound covered by epithelial skin layer or scar) without drainage or dressing requirements., Proportion of patients with Patient-Level Stopping Criteria (PLSC) or rescue therapy, Time to early stop of study medication due to PLSC or due to opting for rescue therapy, Clinician’s Global Impression of Change (CGI-C) from baseline at EOT visit based on a 7-point scale, Proportion of patients achieving Physician’s Global Assessment (PGA) score ≤ 1 of the target ulcer up to and including EOT visit., Proportion of patients achieving PGA ≤ 3 of the target ulcer up to and including EOT visit

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