CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 116 enrolled
Drug / intervention
evinacumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03409744
NCT03409744Phase 3Completed

An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

Regeneron Pharmaceuticals·interventional·Posted Jan 24, 2018·Updated Apr 8, 2025

In Brief

A Phase 3 clinical trial evaluating evinacumab for Homozygous Familial Hypercholesterolemia. Completed, enrolled 116 participants across 38 sites in 12 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Canada, Czechia, France, Greece, Italy, Japan, Netherlands, South Africa, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJan 24, 2018
Enrollment StartMar 13, 2018
Primary CompletionApr 13, 2023
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 8.4 years ago

Interventions

evinacumabdrug

Intravenous (IV) administration