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Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia

Homozygous Familial Hypercholesterolemia Clinical Trial

Official title:
A Three-Part, Single-Arm, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia

Clinical Trial Summary

The primary objective for Part A of the study is to assess the pharmacokinetics (PK) of evinacumab in pediatric patients with homozygous familial hypercholesterolemia (HoFH). The primary objective for Part B of the study is to demonstrate a reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab in pediatric (5 to 11 years of age) patients with HoFH. The secondary objective for Part A of the study is to evaluate the safety and tolerability of evinacumab administered intravenous (IV) in pediatric patients with HoFH. The secondary objectives for Part B of the study are: - To evaluate the effect of evinacumab on other lipid parameters (ie, apolipoprotein B (Apo B), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein a [Lp(a)]) in pediatric patients with HoFH - To evaluate the safety and tolerability of evinacumab administered IV in pediatric patients with HoFH - To assess the PK of evinacumab in pediatric patients with HoFH - To assess the immunogenicity of evinacumab in pediatric patients with HoFH over time - To evaluate patient efficacy by mutation status

Clinical Trial Description

Part A is Phase 1b Part B is Phase 3 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04233918
Study type Interventional
Source Regeneron Pharmaceuticals
Contact
Status Completed
Phase Phase 3
Start date June 29, 2020
Completion date May 30, 2023
View Details
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