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A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Mar 2025

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At a glance

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

Most Recent Events

  • 26 Mar 2024 According to an Argenx media release, company announced that Japans Ministry of Health, Labour and Welfare (MHLW) approved VYVGART (efgartigimod alfa) for intravenous (IV) use in adults with primary immune thrombocytopenia (ITP). The approval of VYVGART is based on results from this global Phase 3 ADVANCE-IV trial.
  • 12 Dec 2023 Results presented at the 65th American Society of Hematology Annual Meeting and Exposition.
  • 28 Nov 2023 According to an Argenx media release, this study formed the basis of the regulatory submission for approval of VYVGART IV for ITP in Japan, where a decision is expected in the first quarter of 2024.

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