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Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy

NCT02326220

CompletedPhase 3

Sponsor: Regeneron Pharmaceuticals

Conditions: Heterozygous Familial Hypercholesterolemia

Interventions: Placebo, Alirocumab

Countries: United States, Germany

The primary objective of the study is to evaluate the effect of alirocumab 150 mg every 2 weeks (Q2W) in comparison with placebo on the frequency of low-density lipoprotein (LDL) apheresis treatments in participants with heterozygous familial hypercholesterolemia (HeFH) undergoing weekly or bi-weekly LDL apheresis therapy.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Men and women ≥18 years of age at the time of the screening visit
2. Diagnosis of HeFH (Heterozygous familial hypercholesterolemia)
3. Currently undergoing LDL (low-density lipoprotein) apheresis therapy QW (weekly) or Q2W (every 2 weeks) or at least 8 weeks prior to the screening visit

Exclusion Criteria:

1. Homozygous FH (familial hypercholesterolemia)
2. Background medical LMT (lipid-modifying therapy) (if applicable) that has not been stable for at least 8 weeks prior to the screening visit
3. LDL apheresis schedule/ apheresis settings that have not been stable for at least 8 weeks prior to the screening visit
4. An LDL apheresis schedule other than QW to Q2W
5. Initiation of a new exercise program or exercise that has not remained stable within 8 weeks prior to the screening visit (week -2)
6. Initiation of a new diet or a diet that has not been stable within 8 weeks prior to the screening visit (week -2)
7. Use of nutraceuticals or over-the-counter therapies known to affect lipids, at a dose/amount that has not been stable for at least 8 weeks prior to the screening visit (week -2), or between the screening and randomization visit
8. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
9. Known history of a positive test for human immunodeficiency virus
10. Use of any active investigational drugs within 1 month or 5 half-lives of screening, whichever is longer
11. Patients who have been treated with at least 1 dose of alirocumab or any other anti-PCSK9 monoclonal antibody in any other clinical studies
12. Pregnant or breastfeeding women

Locations (13)

Aurora, Colorado, United States
Hartford, Connecticut, United States
Kansas City, Kansas, United States
Scarborough, Maine, United States
Rochester, Minnesota, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Dresden, Saxony, Germany
Berlin, Germany
Göttingen, Germany
Muenchen (2 Locations), Germany
Passau, Germany
Rostock, Germany