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A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Emapalumab in Adult Patients With HLH

Hemophagocytic Lymphohistiocytoses Clinical Trial

Official title:
A Phase 2/3, Open-label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Emapalumab in Adult Patients With Hemophagocytic Lymphohistiocytosis

Clinical Trial Summary

Hemophagocytic lymphohistiocytosis (HLH) is a rare, life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of several clinical conditions (e.g. autoimmune disease, infection, malignancy). Emapalumab (previously referred to as NI-0501) is a monoclonal antibody neutralizing interferon-gamma (IFN-gamma), a key cytokine driving the inflammation and tissue damage seen in HLH. The purpose of this study is to assess the efficacy, safety and pharmacokinetics of emapalumab in adult patients with secondary HLH.

Clinical Trial Description

Study NI-0501-10 is an open-label, single arm, multicenter, Phase 2/3 interventional study. The study enrolls adult patients with hemophagocytic lymphohistiocytosis (HLH), specifically newly diagnosed patients with malignancy-associated HLH (M-HLH), and newly diagnosed or previously treated patients with non-malignancy-associated HLH. ;

Study Design

Related Conditions & MeSH terms

  • Hemophagocytic Lymphohistiocytoses
  • Lymphohistiocytosis, Hemophagocytic
Clinical Trial Details
NCT number NCT03985423
Study type Interventional
Source Swedish Orphan Biovitrum
Contact
Status Terminated
Phase Phase 2/Phase 3
Start date June 2, 2020
Completion date June 29, 2021
View Details
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