NCT04162470

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

An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Paroxysmal Nocturnal Hemoglobinuria

Interventions

Type	Name	Description
DRUG	REGN3918	Subcutaneous (SC) every week (QW) over the treatment period

Timeline

• Start date: 2019-12-03
• Primary completion: 2022-04-07
• Completion: 2022-04-07
• First posted: 2019-11-14
• Last updated: 2023-06-12
• Results posted: 2023-06-12

Locations

14 sites across 6 countries: Hong Kong, Hungary, Malaysia, South Korea, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study