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A Phase 2/3 Open-label Single Arm Multicentre Study to Assess Safety Tolerability Pharmacokinetics and Efficacy of i.v. Administrations of NI-0501 an Anti-IFNγ mAb in Paediatric Patients With Primary Haemophagocytic Lymphohistiocytosis

Trial Profile

A Phase 2/3 Open-label Single Arm Multicentre Study to Assess Safety Tolerability Pharmacokinetics and Efficacy of i.v. Administrations of NI-0501 an Anti-IFNγ mAb in Paediatric Patients With Primary Haemophagocytic Lymphohistiocytosis

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 23 Feb 2023

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At a glance

  • Drugs Emapalumab (Primary) ; Dexamethasone
  • Indications Haemophagocytic lymphohistiocytosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Light Chain Bioscience; Swedish Orphan Biovitrum
  • Most Recent Events

    • 14 Dec 2021 Results of prespecified (n=34) exploratory exposure-safety analyses that were performed on data from patients with primary HLH receiving emapalumab in the pivotal trial from pivotal phase 2/3 study (NCT01818492) and its long-term follow-up study (NCT02069899), presented at the 63rd American Society of Hematology Annual Meeting and Exposition.
    • 05 Oct 2021 This trial has been discontinued in Sweden, according to European Clinical Trials Database record.
    • 08 Dec 2020 Protocol was amended which allowed for concomitant use of other HLH treatments if deemed appropriate by the investigator, as per the results presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology.
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