Trial intelligence / Profile preview

Efgartigimod PH20 SC for active idiopathic inflammatory myopathy

NL-OMON59049Phase 3Completed

Sponsor
argenx
Start
Mar 2024
Modality
Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics
Countries
1
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Overview

Phase 3, randomised, double-blind trial in Autoimmune Myopathies, dermatomyositis (DM), polymyositis (PM) and 3 more comparing Efgartigimod PH20 SC plus standard of care with Placebo plus standard of care (2 arms). Primary endpoint: Mean total improvement score at week 52. Started Mar 2024; status: completed.

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Drugs

efgartigimod alfa
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Conditions

Autoimmune Myopathiesdermatomyositis (DM)polymyositis (PM)antisynthetase syndrome (ASSD)immune-mediated necrotizing myopathy (IMNM)

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