Decision: Favourable

Decisions Table

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:

    23-NREC-CT-003

  • Decision:

    Favourable

  • Meeting Date:

    25/01/2023

  • Study Type:

    CT application

  • Principal Investigator:

    Prof Trevor Duffy

  • PI Institution:

    Connolly Hospital

  • Sponsor:

    Argenx BV

Scroll to Top