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A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants with Active Idiopathic Inflammatory Myopathy.

Testing Efgartigimod PH20 SC for adult muscle inflammation.

Recruiting
18 years and older
All
Phase 2/3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is about testing if a new treatment called efgartigimod PH20 SC works and is safe for adults with a group of muscle diseases called Idiopathic Inflammatory Myopathy (IIM). IIM includes types like dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), and some types of polymyositis (PM). The study compares the new treatment to a placebo, which is a harmless substance with no treatment effect, and measures how well it works using a Total Improvement Score (TIS).

Key Points:

  • Duration and Visits: Participants will need to visit the study site regularly for check-ups.
  • Eligibility: You should have specific types of IIM and be taking approved background treatments.
  • Risks and Benefits: The study will check for any side effects and how well the treatment works.

To join, you must be able to give consent, have a confirmed diagnosis of IIM, and not have any other serious health issues that could affect the study. You also must not be pregnant and should not have participated in a similar study before. For more details, visit https://myositis-study.com/.

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Study details
    Active Idiopathic Inflammatory Myopathy
    Myositis
    Dermatomyositis
    Polymyositis
    Immune-Mediated Necrotizing Myopathy
    Antisynthetase Syndrome

NCT05523167

argenx

5 January 2025

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