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A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy

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Trial Profile

A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 23 Aug 2026

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At a glance

  • Drugs Efgartigimod alfa (Primary)
  • Indications Antisynthetase syndrome; Dermatomyositis; Immune-mediated necrotising myopathy; Myositis; Polymyositis
  • Focus Registrational; Therapeutic Use
  • Acronyms ALKIVIA
  • Sponsors argenx

Most Recent Events

  • 17 Aug 2026 According to an Argenx media release, company will host an investor conference call and webcast today at 2:30 PM CET/ 8:30 AM ET to discuss the results.
  • 17 Aug 2026 According to an Argenx media release, Detailed results from the ALKIVIA study will be presented at an upcoming medical meeting.
  • 17 Aug 2026 Results presented in the Argenx media release.

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