R1500-CL-1719 Safety and Efficacy Evinacumab in HoFH
Research type
Research Study
Full title
An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients with Homozygous Familial Hypercholesterolemia
IRAS ID
254319
Contact name
Handrean Soran
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2017-003170-13
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
R1500-CL-1719 is an open-label study designed to evaluate the long-term safety and efficacy of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH). Evinacumab (also referred to as REGN1500) is a fully human IgG4 monoclonal antibody that binds human angiopoietin-like protein 3 (ANGPTL3) and decreases LDL-C and triglyceride levels. This study includes male and female patients age 18 years and older with HoFH, receiving stable lipid-modifying therapy. Patients may include those who have participated in a previous evinacumab study and evinacumab-naïve patients with HoFH.
The primary objective of the study is to evaluate the long-term safety and tolerability of evinacumab 15 mg/kg intravenous (IV) administered every 4 weeks in patients with HoFH. This study consists of 4 periods: a run-in period, a screening period, an open-label treatment period, and a follow-up period. Study duration may vary for each patient,it will range from months up to approximately 4 years.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0761
Date of REC Opinion
12 Mar 2019
REC opinion
Further Information Favourable Opinion