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A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFNγ) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH)

Trial Profile

A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFNγ) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 11 Nov 2019

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At a glance

  • Drugs Emapalumab (Primary)
  • Indications Macrophage activation syndrome
  • Focus Adverse reactions; Biomarker; Pharmacodynamics; Pharmacokinetics
  • Sponsors Light Chain Bioscience
  • Most Recent Events

    • 15 Jun 2019 Results (n=6) presented at the 20th Annual Congress of the European League Against Rheumatism
    • 31 Aug 2018 Biomarkers information updated
    • 22 Mar 2018 Planned number of patients changed from 5 to 10.
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