InflaRx N.V. announced details related to the design of its planned Phase III study with vilobelimab in ulcerative PG. The planned Phase III study is designed to enroll patients in the US, Europe and selected countries in other regions. The enrollment period is projected to be at least two years, depending on the total trial size after sample size adaptation. The multi-national, randomized, double-blind, placebo-controlled Phase III trial will have two arms: vilobelimab plus a low dose of corticosteroids and placebo plus the same low dose of corticosteroids. In both arms, corticosteroid treatment will be initiated on day 1 and will be tapered off within the first 8 weeks of the trial. The primary endpoint of the study will be complete closure of the target ulcer at any time up to 26 weeks after initiation of treatment. Treatment will be discontinued for patients whose disease progresses or fails to improve at defined time points during the study. The study has an adaptive trial design with an interim analysis blinded for the sponsor and investigators planned upon enrollment of approximately 30 patients. The interim analysis with a set of predefined rules will take into account the then-observed difference in complete target ulcer closure between the two arms and, accordingly, the trial sample size will be adapted or the trial will be stopped due to futility.
Published first on TheFly
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