Last updated on December 2019

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

Brief description of study

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

Clinical Study Identifier: NCT03946748

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