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A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study Followed by an Open-Label Arm to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia

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A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study Followed by an Open-Label Arm to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Apr 2025

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At a glance

  • Drugs Efgartigimod alfa (Primary)
  • Indications Idiopathic thrombocytopenic purpura
  • Focus Registrational; Therapeutic Use
  • Acronyms advance NEXT
  • Sponsors argenx

    • Most Recent Events

    • 27 Feb 2025 According to an argenx media release, topline results expected in second half of 2026 to support FDA submission of VYVGART IV for primary ITP.
    • 10 Dec 2024 According to Trial design presented at the 66th American Society of Hematology Annual Meeting and Exposition, this trial will take place in 20 countries globally.
    • 10 Dec 2024 Trial design presented at the 66th American Society of Hematology Annual Meeting and Exposition.

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