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
Latest Information Update: 15 Oct 2024
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
- 17 Jun 2024 According to an Argenx media release, company announced that it will host an R&D day on Tuesday, July 16, 2024 and provide updates from this trial.
- 09 May 2024 According to an Argenx media release, topline data is expected in second half of 2024.
- 31 Oct 2023 According to an Argenx media release, GO/NO GO decision expected from ALKIVIA (myositis) in second half of 2024.