Phase 3
Completed N=69
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
Hypercholesterolaemia
Source: ClinicalTrials.gov NCT03415178 ↗
Enrolled (actual)
69
Serious AEs
3.0%
Results posted
Sep 2019
Primary outcomePrimary: Percentage of SYDNEY-Associated Product Technical Complaints (PTCs) (Overall) at the Unsupervised Injections: Single-Arm Period — 0.5 percentage of PTCs
◆ Published Evidence
Emerging
8citations · ~1 / year
The SYDNEY Device Study: A Multicenter, Randomized, Open-label Usability Study of a 2-mL Alirocumab Autoinjector Device.
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.
Linked Publications
-
The SYDNEY Device Study: A Multicenter, Randomized, Open-label Usability Study of a 2-mL Alirocumab Autoinjector Device.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of SYDNEY-Associated Product Technical Complaints (PTCs) (Overall) at the Unsupervised Injections: Single-Arm Period |
0.5 | — |
| PRIMARY Percentage of SYDNEY-Associated Product Technical Complaints (PTCs) (by Type) at the Unsupervised Injections: Single-Arm Period |
0; 0.5; 0 | — |
| SECONDARY Percentage of Participants With a SYDNEY or Current Auto-Injector (AI)-Associated Product Technical Complaint (PTCs) (Overall and by Type) at the Supervised Injections on Week 0 (Day 1): Parallel-Arm Period |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With SYDNEY-Associated Product Technical Complaint (PTCs) (Overall and by Type) at the Unsupervised Injections : Single-Arm Period |
1.5; 0; 1.5; 0 | — |
| SECONDARY Injection Experience Questionnaire at Initial Supervised Injection: Overall Ease of Use Scores: Parallel-Arm Period |
9.9; 9.8 | — |
| SECONDARY Patient Perspective Questionnaire After the Last Injection (at Week 12): Single-Arm Period |
9.7; 9.8; 9.9; 9.9; 10.0; 10.0 | — |
| SECONDARY Injection-Treatment Acceptance Questionnaire (I-TAQ©) After Last Injection (at Week 12) - Overall Acceptance Scores: Single-Arm Period |
93.08 | — |
| SECONDARY Maximum Serum Alirocumab Concentration Observed - Cmax : Parallel-Arm Period |
25800; 26800 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alirocumab : Parallel-Arm Period |
7.00; 7.00 | — |
| SECONDARY Area Under the Curve-During the Dosing Interval Tau (AUC [0-tau]) : Parallel-Arm Period |
381000; 414000 | — |
| SECONDARY Maximum Serum Alirocumab Concentration Observed - Cmax : Single-Arm Period |
31900 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alirocumab: Single-Arm Period |
7.00 | — |
| SECONDARY Area Under the Curve-During the Dosing Interval Tau (AUC [0-tau]) : Single-Arm Period |
509000 | — |
| SECONDARY Free Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Parallel-Arm Period |
90.1; 78.3 | — |
| SECONDARY Free Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Single-Arm Period |
88.9 | — |
| SECONDARY Total Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Parallel-Arm Period |
3329.7; 3370.0 | — |
| SECONDARY Total Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Single-Arm Period |
3481.4 | — |
| SECONDARY Number of Participants With Treatment-Emergent Anti-Alirocumab Antibodies (ADA) Positive Response: Parallel-Arm Period |
2; 1 | — |
| SECONDARY Number of Participants With Treatment-Emergent Anti-Alirocumab Antibodies (ADA) Positive Response According to ADA Status During Parallel-Arm Period: Single Arm Period |
0; 2; 0 | — |
| SECONDARY Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 4: Parallel-Arm Period |
-51.2; -66.2 | — |
| SECONDARY Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8, 12, 16: Single-Arm Period |
-53.737; -58.610; -56.991 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT03415178) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.