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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

Trial Profile

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

Status: Suspended
Phase of Trial: Phase III

Latest Information Update: 04 Jun 2025

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At a glance

  • Drugs Vilobelimab (Primary)
  • Indications Pyoderma gangrenosum
  • Focus Registrational; Therapeutic Use
  • Sponsors InflaRx

Most Recent Events

  • 02 Jun 2025 Status changed from recruiting to suspended.
  • 28 May 2025 According to an InflaRx media release, company announced that the Independent Data Monitoring Committee (IDMC) conducting the unblinded interim analysis for the Phase 3 trial for vilobelimab in pyoderma gangrenosum (PG), recommended that the trial be stopped due to futility. This recommendation was based on data analysis of the first 30 patients enrolled in the study, with no unexpected adverse events noted by the IDMC.
  • 07 May 2025 According to an InflaRx media release, total enrollment is projected to last at least two years, and the overall timing will depend on the total trial size after sample size adaptation.

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