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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: 29 May 2025

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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

  • 28 May 2025 According to Swedish Orphan Biovitrum media release, company will present data from this trial at the annual European Congress of Rheumatology (EULAR 2025) in Barcelona from the 11-14 June 2025.
  • 27 Feb 2025 According to Sobi media release, company announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Gamifant (emapalumab-Izsg) for use in adult and paediatric patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in Still's disease. The application was granted Priority Review with a PDUFA date of June 27
  • 04 Apr 2023 Results presented in a Swedish Orphan Biovitrum media release.

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