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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: 27 Nov 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

  • 24 Oct 2025 According to a Swedish Orphan Biovitrum media release, data from this trial will be presented at the annual American College of Rheumatology (ACR) Convergence 2025 meeting in Chicago, October 24-29.
  • 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.

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