Decision: Favourable

Study Title:

A Phase 2/3, Randomized, Double-Blinded, PlaceboControlled, 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

  • NREC Code:


  • Decision:


  • Meeting Date:


  • Study Type:

    CT application

  • Principal Investigator:

    Prof Trevor Duffy

  • PI Institution:

    Connolly Hospital

  • Sponsor:

    Argenx BV

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