A study to investigate efficacy and safety of Efgartigimod (ARGX-113) in IIM patients; alkivia

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1005422

• Contact name

  Sabine Coppieters

• Contact email

  regulatory@argenx.com

• Sponsor organisation

  argenx BV

• Eudract number

  2021-001277-23

• Clinicaltrials.gov Identifier

  NCT05523167

• Research summary

  The main aim of this study in myositis is to investigate: the effectiveness of the study drug to control myositis signs and symptoms safety of the study drug tolerability of the study drug effect of the study drug what the body does with the study drug the possible immune reaction of the body against the study drug.
  This study is placebo-controlled which means that one test group will receive the study drug and the other group will receive a placebo of the study drug. This study is also double-blinded, which means that neither the study participants, nor the medical personnel following up the study participants know who is receiving the study drug or the placebo.
  This study consists of 2 parts. About 240 participants in total will take part: 90 participants in the so called phase 2 (proof-of-concept part), and 150 participants in the so called phase 3 (confirmatory part). The first part of the study, the phase 2, will last up to 36 weeks (approximately 8 months), including a screening period of up to 4 weeks and a treatment period of up to 24 weeks. The second part of the study, the phase 3, will last up to 64 weeks (approximately 15 months), including a screening period of up to 4 weeks and a treatment period of up to 52 weeks. After the treatment period participants have the choice to enter an open-label extension study, or enter into a 8-week treatment-free follow-up period. Participants will undergo procedures such as blood samples, physical examination and electrocardiogram.

• REC name

  HSC REC B

• REC reference

  22/NI/0170

• Date of REC Opinion

  11 Jan 2023

• REC opinion

  Further Information Favourable Opinion