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A pivotal, biomarker-guided, multiregional, randomized, placebo-controlled study of enibarcimab for Septic-shock

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Trial Profile

A pivotal, biomarker-guided, multiregional, randomized, placebo-controlled study of enibarcimab for Septic-shock

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 27 Jun 2022

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At a glance

  • Drugs Enibarcimab (Primary)
  • Indications Septic shock
  • Focus Registrational; Therapeutic Use
  • Sponsors Adrenomed

    • Most Recent Events

    • 20 Jun 2022 According to a Adrenomed media release, the company appoints Dr. med. Jens Zimmermann and Dr. Sturzebecher as Chief Medical Officer who have been working jointly for the past two months on further substantiating Adrenomed regulatory strategy and design of this upcoming pivotal trial
    • 09 Dec 2021 New trial record
    • 02 Dec 2021 According to a Adrenomed media release, based on results from AdrenOSS-2 study company has received a positive feedback from EMA for this pivotal trial. The study results will serve as the basis for the marketing authorization application for Adrecizumab in different regions. Further interactions with regulatory authorities are currently being prepared.

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