Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
Completed · Phase 3 · Has a placebo group
Conditions studied: Homozygous Familial Hypercholesterolemia
In brief
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 with homozygous familial hypercholesterolemia (HoFH). The secondary objectives of the study are to evaluate the effect of evinacumab IV on other lipid parameters, evaluate the effect of evinacumab on LDL-C goal attainment, assess the effect of evinacumab on eligibility for apheresis (using German and US apheresis criteria), evaluate the safety and tolerability of evinacumab in patients with HoFH, assess the pharmacokinetics (PK) of evinacumab in patients with HoFH and evaluate the potential development of anti-evinacumab antibodies.
Key facts
- Study ID
- NCT03399786
- Run by
- Regeneron Pharmaceuticals
- People needed
- 65
- Starts
- 2018-01-18
- Expected to finish
- 2020-03-17
- Last updated by the study team
- 2021-05-18
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Regeneron Research Site — Boca Raton, Florida, United States
- Regeneron Research Site — Boston, Massachusetts, United States
- Regeneron Research Site — New York, New York, United States
- Regeneron Research Site — Cincinnati, Ohio, United States
- Regeneron Research Site — Portland, Oregon, United States
- Regeneron Research Site — Dallas, Texas, United States
- Regeneron Research Site — Camperdown, New South Wales, Australia
- Regeneron Research Site — Perth, Western Australia, Australia
- Regeneron Research Site — Innsbruck, Austria
- Regeneron Research Site — Chicoutimi, Quebec, Canada
- Regeneron Research Site — Québec, Quebec, Canada
- Regeneron Research Site — Paris, Cedex, France
- Regeneron Research Site — Marseille, France
- Regeneron Research Site — Ioannina, Ioannina, Greece
- Regeneron Research Site — Athens, Greece
- Regeneron Research Site # 2 — Naples, Italy
- Regeneron Research Site — Kurume, Fukuoka, Japan
- Regeneron Research Site — Nishinomiya, Hyōgo, Japan
- Regeneron Research Site — Kanazawa, Ishikawa-ken, Japan
- Regeneron Research Site #3 — Suita, Osaka, Japan
- Regeneron Research Site — Suita, Osaka, Japan
- Regeneron Research Site — Osaka, Japan
- Regeneron Research Site — Amsterdam, Netherlands
- Regeneron Research Site — Rotterdam, Netherlands
- Regeneron Research Site — Parktown, Johannesburg, South Africa
Full record on ClinicalTrials.gov
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