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A Two-cohort, Open-label, Single arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still's disease (Including Systemic Juvenile Idiopathic Arthritis and Adult onset Still's disease) or with MAS in Systemic Lupus Erythematous

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Trial Profile

A Two-cohort, Open-label, Single arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still's disease (Including Systemic Juvenile Idiopathic Arthritis and Adult onset Still's disease) or with MAS in Systemic Lupus Erythematous

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jul 2025

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At a glance

  • Drugs Emapalumab (Primary)
  • Indications Adult-onset Still's disease; Juvenile rheumatoid arthritis; Macrophage activation syndrome; Systemic lupus erythematosus
  • Focus Registrational; Therapeutic Use
  • Acronyms EMERALD; NI0501-14
  • Sponsors 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).
  • 11 Jun 2025 Status changed from active, no longer recruiting to completed.
  • 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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