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A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy and Safety of Subcutaneous Administration of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

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Trial Profile

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy and Safety of Subcutaneous Administration of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Mar 2024

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At a glance

  • Drugs Garadacimab (Primary)
  • Indications Hereditary angioedema
  • Focus Registrational; Therapeutic Use
  • Acronyms VANGUARD
  • Sponsors CSL; CSL Behring

    • Most Recent Events

    • 26 Feb 2024 Second Interim results assessing safety and efficacy of garadacimab in patients with hereditary angioedema From the Phase 3 (VANGUARD) study and open-label extension presented at the 2024 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
    • 14 Dec 2023 According to a CSL media release, the European Medicines Agency (EMA) has accepted the submission for Marketing Authorization Application (MAA) for garadacimab, based on data from this trial.
    • 14 Dec 2023 According to a CSL media release, the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for garadacimab as a once-monthly prophylactic treatment for hereditary angioedema (HAE), based on data from this trial.

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