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

NCT ID: NCT03415178

Last Updated: 2019-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-29
• Study Completion Date: 2018-08-09

Brief Summary

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.

Detailed Description

Total study duration per participant was expected to be up to 18 weeks, with up to 2 weeks of screening period and 16 weeks of study treatment period.

Conditions

Hypercholesterolaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Auto-Injector Device (AI)

Alirocumab 300 milligram (mg) subcutaneous (SC) injection on Week 0 (Day 1), self-administered using AI device, on-site under supervision in the parallel arm treatment period of 4 weeks. From Week 4, participants switched to other arm of SYDNEY device to receive Alirocumab 300 mg, self- administered (unsupervised) using new auto-injector device (SYDNEY) every 4 weeks (Q4W) from Week 4 until Week 16 in the single arm treatment period added to lipid modifying therapy (LMT).

Group Type: EXPERIMENTAL

Alirocumab SAR236553

Intervention Type: DRUG

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Current auto-injector device (AI)

Intervention Type: DEVICE

Pharmaceutical form:

Route of administration: Subcutaneous self-administration of alirocumab

Atorvastatin

Intervention Type: DRUG

Pharmaceutical form:tablet Route of administration: oral

Rosuvastatin

Intervention Type: DRUG

Pharmaceutical form:tablet Route of administration: oral

New Auto-injector Device (SYDNEY)

Alirocumab 300 mg SC injection on Week 0 (Day 1), self-administered using new auto-injector device (SYDNEY), on-site under supervision in the parallel arm treatment period of 4 weeks. From Week 4, same treatment (Alirocumab 300 mg) with the same device (SYDNEY) was self-administered, (unsupervised) Q4W until Week 16 in the single arm treatment period added to LMT. Duration of single arm treatment period was 12 weeks, i.e. from Week 4 to 16.

Group Type: EXPERIMENTAL

Alirocumab SAR236553

Intervention Type: DRUG

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

New auto-injector device (SYDNEY)

Intervention Type: DEVICE

Pharmaceutical form:

Route of administration: Subcutaneous self-administration of alirocumab

Atorvastatin

Intervention Type: DRUG

Pharmaceutical form:tablet Route of administration: oral

Rosuvastatin

Intervention Type: DRUG

Pharmaceutical form:tablet Route of administration: oral

Interventions

Alirocumab SAR236553

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Intervention Type: DRUG

Current auto-injector device (AI)

Pharmaceutical form:

Route of administration: Subcutaneous self-administration of alirocumab

Intervention Type: DEVICE

New auto-injector device (SYDNEY)

Pharmaceutical form:

Route of administration: Subcutaneous self-administration of alirocumab

Intervention Type: DEVICE

Atorvastatin

Pharmaceutical form:tablet Route of administration: oral

Intervention Type: DRUG

Rosuvastatin

Pharmaceutical form:tablet Route of administration: oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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

Countries

United States

References

Frias JP, Koren MJ, Loizeau V, Merino-Trigo A, Louie MJ, Raudenbush MA, Batsu I. The SYDNEY Device Study: A Multicenter, Randomized, Open-label Usability Study of a 2-mL Alirocumab Autoinjector Device. Clin Ther. 2020 Jan;42(1):94-107.e5. doi: 10.1016/j.clinthera.2019.11.008. Epub 2019 Dec 24.

Reference Type: DERIVED

PMID: 31879033 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1186-3466

Identifier Type: OTHER

Identifier Source: secondary_id

MSC14864

Identifier Type: -

Identifier Source: org_study_id