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Alkivia Phase 2/3 Trial of Efgartigimod PH20 SC in Idiopathic Inflammatory Myopathy
jRCT2031240039Phase 3Active, not recruiting
- Sponsor
- argenx
- Start
- May 2024
- Modality
- Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics, Therapeutic Enzymes → Recombinant Proteins and Enzymes
01
Overview
Phase 3, randomised, double-blind trial in Autoimmune Myopathies, dermatomyositis (DM), juvenile dermatomyositis (JDM) and 3 more comparing Efgartigimod PH20 SC + background treatment with Placebo SC + background treatment (2 arms). Primary endpoint: Total Improvement Score (TIS). Started May 2024; status: active, not recruiting.
02
Drugs
efgartigimod alfa + hyaluronidase-qvfc
03
Conditions
Autoimmune Myopathiesdermatomyositis (DM)juvenile dermatomyositis (JDM)polymyositis (PM)antisynthetase syndrome (ASSD)
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