Homozygous familial hypercholesterolemia (HoFH)
Conditions
Interventions
investigational material(s)
Generic name etc : Evinacumab
INN of investigational material : Evinacumab
Therapeutic category code : 218 Agents for hyperlipidemias
Dosage and Administration for Invest
Sponsors
Regeneron Pharmaceuticals, Inc.(ICCC: PAREXEL International)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of functional HoFH 2. 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
Exclusion criteria
Exclusion criteria: 1.LDL-C level 9%) diabetes 7.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 8.Pregnant or breastfeeding women 9.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 10.Sexually active men who are unwilling to use forms of medically acceptable birth control during the study drug treatment period and for 24 weeks after the last dose of study drug Note: Other protocol defined inclusion/exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy LDL-C Percent change in calculated LDL-C from baseline to week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Apolipoprotein B (Apo B) non-High-density lipoprotein cholesterol (non-HDL-C) Total cholesterol (TC) Triglyceride (TG) lipoprotein a [Lp(a)] apolipoprotein CIII (Apo CIII) Percent change in Apolipoprotein B (Apo B) from baseline to week 24 Percent change in non-High-density lipoprotein cholesterol (HDL-C) from baseline to week 24 Percent change in Total cholesterol (TC) from baseline to week 24 Percent change in Triglyceride (TG) from baseline to week 24 Percent change in lipoprotein a [Lp(a)] from baseline to week 24 Percent change in apolipoprotein CIII (Apo CIII) from baseline to week 24 | — |
Countries
Africa, Europe, Japan, North America, Oceania
Outcome results
None listed