drugset / Trial / NCT04162470

REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate Its Long Term Safety, Efficacy and Tolerability.

NCT04162470

Phase 3 Terminated 24 enrolled Regeneron Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of the study is to evaluate the long-term safety, tolerability, and effect on intravascular hemolysis of REGN3918 in patients with paroxysmal nocturnal hemoglobinuria (PNH). The secondary objectives of the study are: * To evaluate the long-term effect of REGN3918 on intravascular hemolysis * To assess the concentrations of total REGN3918 in serum * To evaluate the occurrence of the immunogenicity of REGN3918

Timeline

Start
2019-12-03
Primary completion
2022-04-07
Completion
2022-04-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Pozelimab Monoclonal antibody Subcutaneous