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A Two-cohort, Open-label, Single arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still's disease (Including Systemic Juvenile Idiopathic Arthritis and Adult onset Still's disease) or with MAS in Systemic Lupus Erythematous

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Trial Profile

A Two-cohort, Open-label, Single arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still's disease (Including Systemic Juvenile Idiopathic Arthritis and Adult onset Still's disease) or with MAS in Systemic Lupus Erythematous

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Jul 2024

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At a glance

  • Drugs Emapalumab (Primary)
  • Indications Adult-onset Still's disease; Juvenile rheumatoid arthritis; Macrophage activation syndrome; Systemic lupus erythematosus
  • Focus Registrational; Therapeutic Use
  • Acronyms EMERALD; NI0501-14
  • Sponsors Swedish Orphan Biovitrum

    • Most Recent Events

    • 23 Jul 2024 Status changed from recruiting to active, no longer recruiting.
    • 03 Jun 2023 Results (n=14) assessing the outcomes and safety among pts with MAS treated with emapalumab after 12 months of follow-up, presented at the 24th Annual Congress of the European League Against Rheumatism.
    • 03 Jun 2023 Trial design presented at the 24th Annual Congress of the European League Against Rheumatism.
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