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A phase III clinical trial of Vilobelimab for Hidradenitis Suppurativa (HS)

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Trial Profile

A phase III clinical trial of Vilobelimab for Hidradenitis Suppurativa (HS)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 21 Mar 2022

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At a glance

  • Drugs Vilobelimab (Primary)
  • Indications Hidradenitis suppurativa
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 17 Mar 2022 According to an InflaRx media release, the FDA no longer recommends that the Company use the Hidradenitis Suppurativa Clinical Response Score (HiSCR) as the primary endpoint for the chosen patient population but gives recommendations related to implementation of the modified HiSCR (mHiSCR).
    • 28 Feb 2022 According to an InflaRx media release, given the unexpected details of the feedback from the FDA, InflaRx will pause activities related to the Phase III trial. The Company will seek to clarify the advice received and determine next steps, which will be communicated accordingly. The FDA has not issued a clinical hold.
    • 28 Feb 2022 According to an InflaRx media release, the Company has received an advice letter from the U.S. Food and Drug Administration (FDA) related to its Phase III program with vilobelimab for the treatment of hidradenitis suppurativa (HS). The feedback indicates that the FDA recommends using the Hidradenitis Suppurativa Clinical Response Score (HiSCR) as the primary endpoint in the Phase III trial.
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