Status:
COMPLETED
Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Homozygous Familial Hypercholesterolemia
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab intravenously (IV) in comparison to placebo after 24 weeks in patients w...
Eligibility Criteria
Inclusion
- Key
- Diagnosis of functional HoFH
- If undergoing LDL apheresis, must have initiated LDL apheresis at least 3 months prior to screening and must have been on a stable weekly or every other week schedule and/or stable settings for at least 8 weeks
- Willing to consistently maintain his/her usual low fat or heart-healthy diet for the duration of the study
- Key
Exclusion
- LDL-C level \<70 mg/dL (1.81 mmol/L) at the screening visit
- Background medical Lipid Modifying Therapy (LMT) (if applicable) that has not been stable before the screening visit
- Lipid-apheresis schedule /apheresis settings (if applicable) that have not been stable for at least 8 weeks before the screening visit
- Use of nutraceuticals or over-the-counter therapies known to affect lipids, at a dose/amount that has not been stable for at least 4 weeks prior to the screening visit
- Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
- Newly diagnosed (within 3 months prior to randomization visit) diabetes mellitus or poorly controlled (HbA1c \>9%) diabetes
- History of a MI, unstable angina leading to hospitalization, coronary artery bypass graft surgery, percutaneous coronary intervention, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack, valve replacement surgery, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior to the screening visit
- Pregnant or breastfeeding women
- Sexually active women of child bearing potential (WOCBP), who are unwilling to practice a highly effective birth control method prior to the initial dose, during the study, and for 24 weeks after the last dose of study drug
- Men who are sexually active with women of child bearing potential (WOCBP) and are unwilling to consistently use condoms during the study drug treatment period and for 24 weeks after the last dose of study drug regardless of vasectomy status
- Note: Other protocol defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
January 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2020
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03399786
Start Date
January 18 2018
End Date
March 17 2020
Last Update
May 18 2021
Active Locations (30)
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1
Regeneron Research Site
Boca Raton, Florida, United States, 33434
2
Regeneron Research Site
Boston, Massachusetts, United States, 02114
3
Regeneron Research Site
New York, New York, United States, 10029
4
Regeneron Research Site
Cincinnati, Ohio, United States, 45227