Study to Evaluate the Efficacy and Safety of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Summary

The primary objective of the study is to demonstrate a reduction in intravascular hemolysis by REGN3918 over 26 weeks of treatment in patients with active PNH who are treatment-naive to complement inhibitor therapy or have not recently received complement inhibitor therapy. The secondary objectives of the study are: * To evaluate the safety and tolerability of REGN3918. * To evaluate the effect of REGN3918 on parameters of intravascular hemolysis * To assess the concentrations of total REGN3918 in serum. * To evaluate the incidence of treatment-emergent anti-drug antibodies to REGN3918 over time * To evaluate the effect of REGN3918 on patient-reported outcomes (PROs) measuring fatigue and health-related quality of life

Timeline

Start

2019-05-16

Primary completion

2021-06-09

Completion

2021-06-10

Drugs

Indications