drugset / Trial / NCT03985423

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

NCT03985423

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-06-02
Primary completion
2021-06-29
Completion
2021-06-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Emapalumab Monoclonal antibody 3 mg/kg Intravenous