Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment
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ClinicalTrials.gov Identifier: NCT02585895 |
Recruitment Status :
Completed
First Posted : October 26, 2015
Results First Posted : September 19, 2017
Last Update Posted : September 19, 2017
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Condition or disease | Intervention/treatment | Phase |
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Hypercholesterolemia | Biological: Evolocumab Procedure: Low-density Lipoprotein Cholesterol (LDL-C) Apheresis | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 39 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Actively Controlled, Open-label, Multicenter Study of Efficacy and Safety of Evolocumab Compared With Low Density Lipoprotein Cholesterol (LDL-C) Apheresis, Followed by Single-Arm Evolocumab Administration in Subjects Receiving LDL-C Apheresis Prior to Study Enrollment |
Actual Study Start Date : | December 21, 2015 |
Actual Primary Completion Date : | September 1, 2016 |
Actual Study Completion Date : | January 20, 2017 |

Arm | Intervention/treatment |
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Experimental: Evolocumab
Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
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Biological: Evolocumab
Administered by subcutaneous injection once every 2 weeks
Other Names:
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Active Comparator: Low Density Lipoprotein Cholesterol (LDL-C) Apheresis
Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
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Biological: Evolocumab
Administered by subcutaneous injection once every 2 weeks
Other Names:
Procedure: Low-density Lipoprotein Cholesterol (LDL-C) Apheresis Participants received apheresis for LDL-C according the their physician's prescription and local custom. |
- Percentage of Participants With Apheresis Avoidance at the End of Randomized Therapy [ Time Frame: Week 5 and week 6 ]
Avoidance of apheresis at end of randomized therapy was defined as no apheresis at week 5 and week 6. Aperesis at weeks 5 or 6 was based on LDL-C level at week 4:
participants with LDL-C ≥ 100 mg/dL at week 4 received apheresis at week 5 (participants who received apheresis QW before study entry) or week 6 (participants who received apheresis Q2W prior to study entry). If LDL-C was < 100 mg/dL at week 4, no apheresis was performed at week 5 or week 6, irrespective of assigned treatment group.
Participants who ended the study prior to week 6 were considered as not achieving apheresis avoidance.
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol [ Time Frame: Baseline and week 4 ]
- Percent Change From Baseline in Non-high-density Lipoprotein-Cholesterol [ Time Frame: Baseline and Week 4 ]
- Percent Change From Baseline in Total Cholesterol/High-density Lipoprotein Cholesterol Ratio [ Time Frame: Baseline and Week 4 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female, ≥ 18 years of age
- Subject has been receiving regular apheresis for LDL-C lowering for at least 3 months immediately prior to lipid screening and has a treatment goal of LDL-C < 100 mg/dL (2.6 mmol/L), and has been receiving LDL-C apheresis during the last ≥ 4 weeks prior to lipid screening at regular QW or Q2W schedule and with no changes in apheresis type
- Subject is receiving lipid-lowering pharmacological background therapy which includes a high-intensity statin dose (moderate-intensity statin dose with attestation that a higher dose is not appropriate for the subject) unless the subject has a history of statin intolerance
- Lipid-lowering therapy status (ie, any therapy for lowering lipids, including apheresis type and frequency) must be unchanged for ≥ 4 weeks prior to LDL-C screening
- Pre-apheresis LDL-C is ≥ 100 mg/dL (≥ 2.6 mmol/L) and ≤ 190 mg/dL (≤ 4.9 mmol/L) at screening
- Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) at screening.
Exclusion criteria:
- Known homozygous familial hypercholesterolemia
- Missing any apheresis session is medically contraindicated or inappropriate
- Stopping apheresis would be inappropriate in the opinion of the investigator even if LDL-C is controlled to < 100 mg/dL with other therapies
- Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization.
- Uncontrolled hypertension

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585895
United States, Florida | |
Research Site | |
Boca Raton, Florida, United States, 33434 | |
United States, Kansas | |
Research Site | |
Kansas City, Kansas, United States, 66160 | |
United States, Michigan | |
Research Site | |
Grandville, Michigan, United States, 49418 | |
United States, Oregon | |
Research Site | |
Portland, Oregon, United States, 97239 | |
Australia, Victoria | |
Research Site | |
Heidelberg, Victoria, Australia, 3084 | |
Czechia | |
Research Site | |
Hradec Kralove, Czechia, 500 05 | |
France | |
Research Site | |
Bron, France, 69677 | |
Research Site | |
Nantes Cedex 1, France, 44093 | |
Germany | |
Research Site | |
Berlin, Germany, 13353 | |
Research Site | |
Dresden, Germany, 01307 | |
Research Site | |
Düsseldorf, Germany, 40210 | |
Research Site | |
Flensburg, Germany, 24939 | |
Italy | |
Research Site | |
Pisa, Italy, 56124 | |
Research Site | |
Roma, Italy, 00161 | |
Spain | |
Research Site | |
Sevilla, Andalucía, Spain, 41013 | |
United Kingdom | |
Research Site | |
Harefield, United Kingdom, UB9 6JH | |
Research Site | |
Penarth, United Kingdom, CF64 2XX |
Study Director: | MD | Amgen |
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT02585895 |
Other Study ID Numbers: |
20140316 2015-001343-37 ( EudraCT Number ) |
First Posted: | October 26, 2015 Key Record Dates |
Results First Posted: | September 19, 2017 |
Last Update Posted: | September 19, 2017 |
Last Verified: | August 2017 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
LDL-C Apheresis Hypercholesterolemia Elevated Cholesterol High Cholesterol |
PCSK9 mutations Severe Familial Hypercholesterolemia evolocumab Repatha |
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Evolocumab |
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