drugset / Trial / NCT03409744

Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

NCT03409744 ↗

Phase 3 Completed 116 enrolled Regeneron Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The primary objectives of the study are: * To evaluate the long-term safety and tolerability of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH) * To evaluate the long-term safety and tolerability of evinacumab in adolescent patients with HoFH The secondary objectives of the study are: * To evaluate the effect of evinacumab on lipid parameters in patients with HoFH * To evaluate the effect of evinacumab on lipid parameters in adolescent patients with HoFH * To evaluate the potential development of anti-evinacumab antibodies

Timeline

Start
2018-03-13
Primary completion
2023-04-13
Completion
2023-04-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Evinacumab Monoclonal antibody — Intravenous