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A Pilot, Open-label, Single Arm, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFNγ) Monoclonal Antibody, in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH)

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Trial Profile

A Pilot, Open-label, Single Arm, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFNγ) Monoclonal Antibody, in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 13 Aug 2024

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At a glance

  • Drugs Emapalumab (Primary)
  • Indications Macrophage activation syndrome
  • Focus Adverse reactions; Biomarker; Pharmacodynamics; Pharmacokinetics; Therapeutic Use
  • Sponsors Light Chain Bioscience; Swedish Orphan Biovitrum

    • Most Recent Events

    • 04 Apr 2023 Results presented in a Swedish Orphan Biovitrum media release.
    • 04 Apr 2023 According to a Swedish Orphan Biovitrum media release, All 14 patients completed the trial, entered long-term follow-up and were alive at the end of follow-up.
    • 31 Mar 2023 Results (n=14) assessing the efficacy and safety of emapalumab in patients with macrophage activation syndrome from NCT02069899 and NCT03311854 studies, published in the Annals of the Rheumatic Diseases.

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