Fourier-OLE

A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Patients With Clinically Evident Cardiovascular Disease

Fourier-OLE [NCT02867813]

Description:  The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).

Biological: Evolocumab

Primary Investigator: Kereiakes

Drug/Device Information
Biological: Evolocumab
The primary objective is to describe the safety and tolerability of long-term administration of evolocumab
Evolocumab is a human monoclonal immunoglobulin (Ig) G2 that binds to PCSK9 and prevents the interaction of PCSK9 with LDLR
Open-label extension study
Evolocumab will be administered either at 140 mg in 1.0 mL (1 administration by prefilled autoinjector/pen) Q2W
Or at 420 mg in 3.0 mL or 3.5 mL (3 administrations by prefilled autoinjector/pen or 1 administration by automated mini-doser, respectively) QM
Q2W or QM dosing is subject’s preference
Amgen Inc.
Major Inclusion and Exclusion
Subject has completed FOURIER (Study 20110118) while still receiving assigned investigational product