Trial Profile

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

Status: Recruiting

Phase of Trial: Phase II/III

Latest Information Update: 15 Jun 2025

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At a glance

Drugs Efgartigimod alfa (Primary)
Indications Antisynthetase syndrome; Dermatomyositis; Immune-mediated necrotising myopathy; Myositis; Polymyositis
Focus Registrational; Therapeutic Use
Acronyms ALKIVIA
Sponsors argenx

10 Jun 2025 Results presented in an Argenx Media Release.
10 Jun 2025 According to an Argenx media release, data form this trial will be presented at the EULAR 2025, from June 11 -14 in Barcelona, Spain.
27 Feb 2025 According to a Zai lab media release, the company is participating in this study Greater China.

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