Study to Evaluate the Efficacy and Safety of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Status:
Completed
Trial end date:
2021-06-10
Target enrollment:
Participant gender:
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