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Clinical trial

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

NCT05523167 is registered in ClinicalTrials.gov with argenx as lead sponsor.

NCT NCT05523167
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Registry record

As filed in ClinicalTrials.gov.

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
Lead sponsor
argenx
Phase
Phase 2/3
Overall status
Completed
Start date
October 12, 2022
Completion date
July 2, 2026
Enrollment
265 (actual)
Sites
202

Conditions

As the registry lists them; a condition with its own page is linked.

active idiopathic inflammatory myopathy, antisynthetase syndrome, dermatomyositis, immune-mediated necrotizing myopathy, myositis, polymyositis