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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: 04 Jul 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 Jun 2025 According to Sobi media release, company announced that the U.S. FDA approved Gamifant for the treatment of adult and pediatric patients with HLH, MAS including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. The approval is based on results of the pooled data from two pivotal studies, the Phase 3 study (NCT05001737) and NI-0501-06 (NCT03311854).
  • 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

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