CLINICAL TRIALS PROFILE FOR EVINACUMAB
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All Clinical Trials for evinacumab
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT03146416 ↗ | Study of Evinacumab (REGN1500) in Caucasian and in Japanese Healthy Volunteers | Completed | Regeneron Pharmaceuticals | Phase 1 | 2017-05-16 | The primary objective of the study is to compare the safety and tolerability of subcutaneous (SC) and intravenous (IV) doses of evinacumab in healthy Japanese and Caucasian subjects. |
| NCT03175367 ↗ | Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia | Completed | Regeneron Pharmaceuticals | Phase 2 | 2017-11-10 | The primary objective of the study is to evaluate the reduction of LDL-C by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or non-HeFH with a history of clinical ASCVD) with persistent hypercholesterolemia despite receiving maximally-tolerated LMT. Persistent hypercholesterolemia is defined as LDL-C ≥70 mg/dL (1.81 mmol/L) for those patients with clinical ASCVD and LDL-C ≥100 mg/dL (2.59 mmol/L) for those patients without clinical ASCVD. |
| NCT03399786 ↗ | Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia | Completed | Regeneron Pharmaceuticals | Phase 3 | 2018-01-18 | 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. |
| NCT03409744 ↗ | Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia | Active, not recruiting | Regeneron Pharmaceuticals | Phase 3 | 2018-03-13 | 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 evaluabe the effect of evinacumab on lipd parameters in adolescent patients with HoFH - To evaluate the potential development of anti-evinacumab antibodies |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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