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: Active, no longer recruiting

Phase of Trial: Phase II/III

Latest Information Update: 20 Feb 2026

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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

13 Jan 2026 According to a ZAI Lab media release, global phase 3 data in myositis are expected in 2H 2026.
23 Jul 2025 Status changed from recruiting to active, no longer recruiting.
10 Jun 2025 Results presented in an Argenx Media Release.

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