Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Completed · Phase 3

Conditions studied: Hypercholesterolaemia

In brief

Primary Objective: To collect real-use (usability) data assessing the robustness and user interaction of the new alirocumab auto-injector device (which is referred to as SYDNEY), in unsupervised settings. Secondary Objective: Device-related: * To collect real-use (usability) data assessing the robustness and user interaction of SYDNEY and the current alirocumab auto-injector device (which is referred to as AI) in supervised settings. Pharmacokinetics: * To compare alirocumab pharmacokinetics (PK) administered using SYDNEY and AI. * To evaluate alirocumab PK administered using SYDNEY. Anti-drug antibodies: * To evaluate the development of anti-drug (alirocumab) antibodies (ADA). Efficacy/pharmacodynamics: * To compare the percent and absolute change in low-density lipoprotein cholesterol (LDL-C) using SYDNEY and AI. * To evaluate the percent and absolute change in LDL-C using SYDNEY. Safety: * To evaluate the safety and tolerability of alirocumab using both SYDNEY and AI.

Key facts

Study ID

NCT03415178

Run by

Sanofi

People needed

69

Starts

2018-03-29

Expected to finish

2018-08-09

Last updated by the study team

2019-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants were in either category A or B (below), and were not adequately controlled with a stable daily dose of atorvastatin (20 mg or 40 mg), or rosuvastatin (10 mg or 20 mg) for at least 4 weeks prior to the screening visit (Week -2), with or without other LMT:
• A. Participants with heterozygous familial hypercholesterolemia (heFH) (diagnosis based on either genotyping or clinical criteria) OR
• B. Non-FH Participants at high or very high cardiovascular (CV) risk. High and very high cardiovascular risk participants included participants with coronary heart disease (CHD), non-CHD cardiovascular disease (CVD), and other risk factors.
• Participant willing and able to self-inject for the duration of the study.

You may not qualify if…

• LDL-C <70 milligrams per deciliter (mg/dL) (<1.81 millimoles per litre [mmol/L]) at the screening visit.
• Currently taking a daily dose of statin that was not atorvastatin 20 mg or 40 mg, or rosuvastatin 10 mg or 20 mg.
• Not on a stable dose of LMT (including statin) for at least 4 weeks, prior to the screening visit and from screening to randomization.
• Having previously used any device for the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor administration, or having participated in any clinical trial for a PCSK9 inhibitor.
• Fasting serum Triglyceride (TG) >400 mg/dL (>4.52 mmol/L) at the screening visit.
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 8400024 — Los Angeles, California, United States
• Investigational Site Number 8400007 — Jacksonville, Florida, United States
• Investigational Site Number 8400017 — Jacksonville, Florida, United States
• Investigational Site Number 8400013 — Ponte Vedra, Florida, United States
• Investigational Site Number 8400014 — Wellington, Florida, United States
• Investigational Site Number 8400001 — West Des Moines, Iowa, United States
• Investigational Site Number 8400019 — Topeka, Kansas, United States
• Investigational Site Number 8400006 — Cincinnati, Ohio, United States
• Investigational Site Number 8400010 — Cincinnati, Ohio, United States
• Investigational Site Number 8400022 — Summerville, South Carolina, United States
• Investigational Site Number 8400026 — Amarillo, Texas, United States
• Investigational Site Number 8400005 — Richmond, Virginia, United States
• Investigational Site Number 8400027 — Manitowoc, Wisconsin, United States

Full record on ClinicalTrials.gov

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