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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Mar 2024

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At a glance

  • Drugs Efgartigimod alfa (Primary) ; Acetylcholinesterase inhibitors; Steroids
  • Indications Myasthenia gravis
  • Focus Registrational; Therapeutic Use
  • Acronyms ADAPT
  • Sponsors argenx
  • Most Recent Events

    • 07 Mar 2024 According to an argenx SE media release, data from this trial, will be presented at the American Academy of Neurology (AAN) Annual Meeting, taking place in Denver, CO from April 13-18, 2024.
    • 01 Jan 2024 Results of post hoc analysis of Effect of efgartigimod on muscle group subdomains in participants with generalized myasthenia gravis, published in the European Journal of Neurology
    • 09 Nov 2023 According to a Halozyme therapeutics media release ,in September 2023, argenx announced the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") has recommended European Commission ("EC") approval of the SC injectable formulation of efgartigimod as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis ("gMG") who are anti-acetylcholine receptor antibody positive.
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