Trial Outcomes & Findings for 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 NCT03415178)
NCT ID: NCT03415178
Last Updated: 2019-09-09
Results Overview
SYDNEY-associated PTC was defined as any complaint reported on the participant complaint form that triggered an investigation by the device department and was categorized as either device-related, participant-related, or undetermined whether or not associated with an adverse event (AE). Overall category included total of all 3 types of PTCs. The percentage of SYDNEY-associated PTCs was calculated as: Number of PTCs / Number of unsupervised injections\*100. The confidence interval (CI) was calculated using the Wilson score method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
69 participants
Primary outcome timeframe
From Week 4 up to Week 12
Results posted on
2019-09-09
Participant Flow
The study was conducted at 13 centers in the United States. A total of 92 participants were screened on 29-March-2018 with randomization between 05 April 2018 and 12 April 18 of whom 23 were screen failures. Screen failures were mainly due to exclusion criteria met.
Randomization to treatment arms was done centrally using treatment allocation system (Interactive Response Technology) in a 1:1 ratio (alirocumab from auto-injector device \[AI\] : alirocumab from new auto-injector device \[SYDNEY\]). A total of 69 participants were randomized.
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Parallel-Arm Period (up to Week 4)
STARTED
|
34
|
35
|
|
Parallel-Arm Period (up to Week 4)
Treated
|
34
|
33
|
|
Parallel-Arm Period (up to Week 4)
COMPLETED
|
34
|
33
|
|
Parallel-Arm Period (up to Week 4)
NOT COMPLETED
|
0
|
2
|
|
Single Arm Period (up to Week 16)
STARTED
|
0
|
66
|
|
Single Arm Period (up to Week 16)
COMPLETED
|
0
|
65
|
|
Single Arm Period (up to Week 16)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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).
|
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.
|
|---|---|---|
|
Parallel-Arm Period (up to Week 4)
Randomized but not treated
|
0
|
2
|
|
Single Arm Period (up to Week 16)
Adverse Event
|
0
|
1
|
Baseline Characteristics
Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - \[Triglyceride/5\]). Here, "Number analyzed" signifies number of participants with available data for this baseline measure.
Baseline characteristics by cohort
| Measure |
Auto-Injector Device (AI)
n=34 Participants
Alirocumab 300 mg 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) Q4W from Week 4 until Week 16 in the single arm treatment period added to LMT.
|
New Auto-injector Device (SYDNEY)
n=35 Participants
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.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 8.6 • n=34 Participants
|
65.4 years
STANDARD_DEVIATION 8.1 • n=35 Participants
|
65.3 years
STANDARD_DEVIATION 8.3 • n=69 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=34 Participants
|
9 Participants
n=35 Participants
|
28 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=34 Participants
|
26 Participants
n=35 Participants
|
41 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=34 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=34 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=34 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=34 Participants
|
3 Participants
n=35 Participants
|
11 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=34 Participants
|
31 Participants
n=35 Participants
|
55 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=34 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=34 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=69 Participants
|
|
Low-Density Lipoprotein Cholesterol (LDL-C)
|
98.6 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 24.3 • n=34 Participants • Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - \[Triglyceride/5\]). Here, "Number analyzed" signifies number of participants with available data for this baseline measure.
|
91.0 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 15.0 • n=34 Participants • Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - \[Triglyceride/5\]). Here, "Number analyzed" signifies number of participants with available data for this baseline measure.
|
94.8 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 20.4 • n=68 Participants • Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - \[Triglyceride/5\]). Here, "Number analyzed" signifies number of participants with available data for this baseline measure.
|
PRIMARY outcome
Timeframe: From Week 4 up to Week 12Population: Analysis was performed on safety population of the single-arm period which included all randomized participants who continued in the single-arm period and received at least 1 dose or part of a dose of investigational medicinal product (IMP) during this period.
SYDNEY-associated PTC was defined as any complaint reported on the participant complaint form that triggered an investigation by the device department and was categorized as either device-related, participant-related, or undetermined whether or not associated with an adverse event (AE). Overall category included total of all 3 types of PTCs. The percentage of SYDNEY-associated PTCs was calculated as: Number of PTCs / Number of unsupervised injections\*100. The confidence interval (CI) was calculated using the Wilson score method.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=196 Number of unsupervised injections
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Percentage of SYDNEY-Associated Product Technical Complaints (PTCs) (Overall) at the Unsupervised Injections: Single-Arm Period
|
0.5 percentage of PTCs
Interval 0.0 to 3.2
|
—
|
PRIMARY outcome
Timeframe: From Week 4 up to Week 12Population: Analysis was performed on safety population of the single-arm period.
SYDNEY-associated PTC was defined as any complaint reported on the participant complaint form that triggered an investigation by the device department and was categorized as either device-related, participant-related, or undetermined whether or not associated with an AE.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=196 Number of unsupervised injections
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Percentage of SYDNEY-Associated Product Technical Complaints (PTCs) (by Type) at the Unsupervised Injections: Single-Arm Period
Device-related
|
0 percentage of PTCs
|
—
|
|
Percentage of SYDNEY-Associated Product Technical Complaints (PTCs) (by Type) at the Unsupervised Injections: Single-Arm Period
Participant-related
|
0.5 percentage of PTCs
|
—
|
|
Percentage of SYDNEY-Associated Product Technical Complaints (PTCs) (by Type) at the Unsupervised Injections: Single-Arm Period
Undetermined
|
0 percentage of PTCs
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Day 1)Population: Analysis was performed on safety population of the parallel-arm period which included all randomized participants who received at least 1 dose or part of a dose of IMP during this period.
A PTC was defined as any complaint reported on the participant complaint form that triggered an investigation by the device department and was categorized as either device-related, participant-related, or undetermined, whether or not associated with an AE. Percentage of participants With a SYDNEY-associated PTC (for the reporting arm "Alirocumab from new auto-injector device") or Current AI-Associated PTCs (for the reporting arm "alirocumab from AI device") are reported.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=34 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
New Auto-Injector Device (SYDNEY)
n=33 Participants
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
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
Overall
|
0 percentage of participants
|
0 percentage of participants
|
|
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
Type: Device-related
|
0 percentage of participants
|
0 percentage of participants
|
|
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
Type: Participant-related
|
0 percentage of participants
|
0 percentage of participants
|
|
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
Type: Undetermined
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Week 4 up to Week 12Population: Analysis was performed on safety population of the single-arm period.
A PTC was defined as any complaint reported on the participant complaint form that triggered an investigation by the device department and was categorized as either device-related, participant-related, or undetermined, whether or not associated with an AE. Percentage of Participants With a SYDNEY-associated PTC (for the reporting arm "Alirocumab from new auto-injector device \[SYDNEY\])" are reported.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=66 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Percentage of Participants With SYDNEY-Associated Product Technical Complaint (PTCs) (Overall and by Type) at the Unsupervised Injections : Single-Arm Period
Overall
|
1.5 percentage of participants
|
—
|
|
Percentage of Participants With SYDNEY-Associated Product Technical Complaint (PTCs) (Overall and by Type) at the Unsupervised Injections : Single-Arm Period
Type: Device-related
|
0 percentage of participants
|
—
|
|
Percentage of Participants With SYDNEY-Associated Product Technical Complaint (PTCs) (Overall and by Type) at the Unsupervised Injections : Single-Arm Period
Type: Participant-related
|
1.5 percentage of participants
|
—
|
|
Percentage of Participants With SYDNEY-Associated Product Technical Complaint (PTCs) (Overall and by Type) at the Unsupervised Injections : Single-Arm Period
Type: Undetermined
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Day 1)Population: Analysis was performed on safety population of the parallel-arm period.
Participants were given an injection experience questionnaire to complete after the self-injection they administered using SYDNEY device or current AI device on Day 1, for assessment of user experience and overall ease-of-use. The questionnaire included 9 questions about specific aspects of using the device. Overall ease of use was the 9th question, response of which ranged from 1 (very difficult) to 10 (very easy), with higher score indicated more ease of use.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=34 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
New Auto-Injector Device (SYDNEY)
n=33 Participants
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Injection Experience Questionnaire at Initial Supervised Injection: Overall Ease of Use Scores: Parallel-Arm Period
|
9.9 score on a scale
Standard Deviation 0.2
|
9.8 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: At Week 12Population: Analysis was performed on safety population of the single-arm period.
The aim of the patient perspective questionnaire (completed by the participant after the last injection) was to generate data to support an understanding of the participant experience and satisfaction associated with use of the large volume SYDNEY to administer the 300 mg dose. The questionnaire consisted of 6 questions about level of satisfaction with various aspects of the SYDNEY; with response to each question ranging from 1 (very dissatisfied) to 10 (very satisfied), with higher scores indicated more satisfaction. An additional question (confidence that Sydney device was used correctly) regarding confidence of use of SYDNEY device in the study was evaluated on a scale of 10; where 1 being not at all confident, to 10 being very confident, higher scores indicated more confidence.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=66 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Patient Perspective Questionnaire After the Last Injection (at Week 12): Single-Arm Period
Size of the auto-injector
|
9.7 score on a scale
Standard Deviation 0.8
|
—
|
|
Patient Perspective Questionnaire After the Last Injection (at Week 12): Single-Arm Period
Ease of holding the auto-injector in hand
|
9.8 score on a scale
Standard Deviation 0.6
|
—
|
|
Patient Perspective Questionnaire After the Last Injection (at Week 12): Single-Arm Period
2-step operation:remove cap, press AI against skin
|
9.9 score on a scale
Standard Deviation 0.4
|
—
|
|
Patient Perspective Questionnaire After the Last Injection (at Week 12): Single-Arm Period
Length of time it took to complete the injection
|
9.9 score on a scale
Standard Deviation 0.3
|
—
|
|
Patient Perspective Questionnaire After the Last Injection (at Week 12): Single-Arm Period
Fact that needle is hidden prior & after injection
|
10.0 score on a scale
Standard Deviation 0.3
|
—
|
|
Patient Perspective Questionnaire After the Last Injection (at Week 12): Single-Arm Period
Once monthly injection
|
10.0 score on a scale
Standard Deviation 0.1
|
—
|
|
Patient Perspective Questionnaire After the Last Injection (at Week 12): Single-Arm Period
Confidence that Sydney device was used correctly
|
9.9 score on a scale
Standard Deviation 0.4
|
—
|
SECONDARY outcome
Timeframe: At Week 12Population: Analysis was performed on safety population of the single-arm period. Here, overall number of participants analyzed = participants who answered the I-TAQ.
The I-TAQ© was a well-established and validated questionnaire to measure participant satisfaction with SC auto-injector devices. The I-TAQ© (completed by the participant after the last injection) was self-administered questionnaire administered to participants in order to measure their acceptance of the injection. The overall acceptance is one of the five domain scores. The overall acceptance score ranged from 0 to 100, with 0 indicating low acceptance and 100 indicating high acceptance.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=65 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Injection-Treatment Acceptance Questionnaire (I-TAQ©) After Last Injection (at Week 12) - Overall Acceptance Scores: Single-Arm Period
|
93.08 score on a scale
Standard Deviation 9.94
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Week 0) and on Day 7, 14 and 21Population: Analysis was performed on pharmacokinetics (PK) population of the parallel-arm period which included all randomized participants who received at least 1 dose or part of a dose of IMP and had at least one evaluable blood sample for PK during this period. Here, "Overall number of participants analyzed" = participants evaluable for this PK measure.
Cmax: Maximum serum concentration observed.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=33 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
New Auto-Injector Device (SYDNEY)
n=31 Participants
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Maximum Serum Alirocumab Concentration Observed - Cmax : Parallel-Arm Period
|
25800 nanogram per milliliter (ng/mL)
Standard Deviation 8430
|
26800 nanogram per milliliter (ng/mL)
Standard Deviation 8420
|
SECONDARY outcome
Timeframe: Pre-dose (Week 0) and on Day 7, 14 and 21Population: Analysis was performed on PK population of the parallel-arm period. Here, "Overall number of participants analyzed" = participants evaluable for this PK measure.
Tmax: Time to reach Cmax.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=33 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
New Auto-Injector Device (SYDNEY)
n=31 Participants
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alirocumab : Parallel-Arm Period
|
7.00 days
Interval 6.0 to 14.0
|
7.00 days
Interval 6.0 to 7.0
|
SECONDARY outcome
Timeframe: Pre-dose (Week 0) and on Day 7, 14 and 21Population: Analysis was performed on PK population of the parallel-arm period. Here, "Overall number of participants analyzed" = participants evaluable for this PK measure.
AUC0-tau: area under the serum concentration versus time curve calculated using the trapezoidal method during a dosage interval tau, where dosing interval was 4 weeks.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=32 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
New Auto-Injector Device (SYDNEY)
n=31 Participants
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Area Under the Curve-During the Dosing Interval Tau (AUC [0-tau]) : Parallel-Arm Period
|
381000 ng*day/mL
Standard Deviation 147000
|
414000 ng*day/mL
Standard Deviation 152000
|
SECONDARY outcome
Timeframe: Pre-dose (Week 4, Week 8 and Week 12) and on Day 7, 14, 21 and 28 days following the last injectionPopulation: Analysis was performed on PK population of the single-arm period which included all randomized participants who received at least 1 dose or part of a dose of IMP and had at least one evaluable blood sample for PK during this period. Here, "Overall number of participants analyzed" = participants evaluable for this PK measure.
Cmax: maximum serum concentration observed.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=64 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Maximum Serum Alirocumab Concentration Observed - Cmax : Single-Arm Period
|
31900 ng/mL
Standard Deviation 13100
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Week 4, Week 8 and Week 12) and on Day 7, 14, 21 and 28 days following the last injectionPopulation: Analysis was performed on PK population of the single-arm period. Here, "Overall number of participants analyzed" = participants evaluable for this PK measure.
Tmax: Time to reach Cmax.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=64 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alirocumab: Single-Arm Period
|
7.00 days
Interval 3.0 to 11.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Week 4, Week 8 and Week 12) and on Day 7, 14, 21 and 28 days following the last injectionPopulation: Analysis was performed on PK population of the single-arm period. Here, "Overall number of participants analyzed" = participants evaluable for this PK measure.
AUC0-tau: area under the serum concentration versus time curve calculated using the trapezoidal method during a dosage interval tau, where dosing interval was 4 weeks.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=63 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Area Under the Curve-During the Dosing Interval Tau (AUC [0-tau]) : Single-Arm Period
|
509000 ng*day/mL
Standard Deviation 264000
|
—
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was performed on PK population of the parallel-arm period. Here, "Overall number of participants analyzed" = participants evaluable for this outcome measure.
Free PCSK9 concentrations below the lower limit of quantification (LLOQ) were set to zero.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=33 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
New Auto-Injector Device (SYDNEY)
n=32 Participants
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Free Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Parallel-Arm Period
|
90.1 ng/mL
Standard Deviation 110.5
|
78.3 ng/mL
Standard Deviation 103.1
|
SECONDARY outcome
Timeframe: Week 16Population: Analysis was performed on PK population of the single-arm period. Here, "Overall number of participants analyzed" = participants evaluable for this PK measure.
Free PCSK9 concentrations below the LLOQ were set to zero.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=65 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Free Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Single-Arm Period
|
88.9 ng/mL
Standard Deviation 116.4
|
—
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was performed on PK population of the parallel-arm period. Here, "Overall number of participants analyzed" = participants evaluable for this outcome measure.
Total PCSK9 concentrations below the LLOQ were set to zero.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=33 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
New Auto-Injector Device (SYDNEY)
n=32 Participants
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Total Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Parallel-Arm Period
|
3329.7 ng/mL
Standard Deviation 1147.7
|
3370.0 ng/mL
Standard Deviation 916.6
|
SECONDARY outcome
Timeframe: Week 16Population: Analysis was performed on PK population of the single-arm period. Here, "Overall number of participants analyzed" = participants evaluable for this PK measure.
Total PCSK9 concentrations below the LLOQ were set to zero.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=65 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Total Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Single-Arm Period
|
3481.4 ng/mL
Standard Deviation 1290.1
|
—
|
SECONDARY outcome
Timeframe: Up to Week 4Population: Analysis was performed on ADA population of the parallel-arm period which included all randomized participants who received at least 1 or part of a dose of IMP during this period with baseline and at least one post-baseline available ADA sample during this period. All participants were analyzed according to the AI device they actually received.
Anti-drug (alirocumab) antibodies samples were analyzed using a validated electrochemiluminescence assay. Number of participants with positive ADA during treatment emergent adverse event (TEAE) period (time from the first IMP injection to the day before the second IMP injection for participants entered into the single arm period or to 70 days after the first IMP injection, whichever comes first) was determined. Treatment-emergent positive ADA response defined as 1) participants with no ADA positive response at baseline but with any positive response in the post-baseline period or 2) participants with a positive ADA response at baseline and at least a 4- fold increase in titer in the post-baseline period.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=32 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
New Auto-Injector Device (SYDNEY)
n=32 Participants
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Anti-Alirocumab Antibodies (ADA) Positive Response: Parallel-Arm Period
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Analysis was performed on ADA population of single-arm period which included all randomized participants who received at least 1 or partial dose of IMP during this period with available baseline and at least 1 post-baseline ADA sample available during this period. Here, "Number analyzed" = participants with ADA assessed at specified time point.
Number of participants with positive ADA during the TEAE period (time from the second IMP injection up to the day of last IMP injection + 70 days) were determined. Treatment-emergent positive ADA response in Single-arm period defined as 1) participants with no ADA positive response in the Parallel-arm period but with any positive response in the Single-arm period or 2) participants with a positive ADA response at baseline, with less than 4-fold increase in titer in the Parallel-arm period (Pre-existing ADA in Parallel-arm period) and at least a 4- fold increase in titer in the Single-arm period.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=64 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Anti-Alirocumab Antibodies (ADA) Positive Response According to ADA Status During Parallel-Arm Period: Single Arm Period
Pre-existing ADA
|
0 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Anti-Alirocumab Antibodies (ADA) Positive Response According to ADA Status During Parallel-Arm Period: Single Arm Period
Negative ADA status
|
2 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Anti-Alirocumab Antibodies (ADA) Positive Response According to ADA Status During Parallel-Arm Period: Single Arm Period
Treatment-emergent ADA positive
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 4Population: Analysis was performed on modified intent-to-treat (mITT) population of the parallel-arm period which included all randomized participants who received at least 1 dose or part of a dose of IMP during this period and who had an evaluable baseline and an on-treatment LDL-C value within Week 4 analysis window and before second injection, if any.
Adjusted least square means and standard errors at Week 4 were calculated from analyses of covariance (ANCOVA) model with the fixed categorical effect of treatment group (SYDNEY, AI), as well as the continuous fixed covariate of baseline LDL-C value.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=32 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
New Auto-Injector Device (SYDNEY)
n=31 Participants
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 4: Parallel-Arm Period
|
-51.2 percent change
Standard Error 4.4
|
-66.2 percent change
Standard Error 4.4
|
SECONDARY outcome
Timeframe: From Baseline to Weeks 8, 12, and 16Population: mITT population of single-arm period included all randomized participants who continued in single-arm period \& received at least 1 dose/part of a dose of IMP \& who had an evaluable baseline \& at least 1 on-treatment LDL-C value within analysis windows (Week 8 to 16). Number analyzed=participants with available data at specified time-point.
Outcome measures
| Measure |
New Auto-Injector Device (SYDNEY)
n=66 Participants
All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
|
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 period of 4 weeks added to LMT.
|
|---|---|---|
|
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8, 12, 16: Single-Arm Period
Week 8
|
-53.737 percent change
Standard Deviation 32.641
|
—
|
|
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8, 12, 16: Single-Arm Period
Week 12
|
-58.610 percent change
Standard Deviation 25.068
|
—
|
|
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8, 12, 16: Single-Arm Period
Week 16
|
-56.991 percent change
Standard Deviation 25.930
|
—
|
Adverse Events
Auto-Injector Device (AI) (Parallel Arm Period)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
New Auto-Injector Device (Parallel-arm Period)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
New Auto-Injector Device (Single-arm Period)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Auto-Injector Device (AI) (Parallel Arm Period)
n=34 participants at risk
Alirocumab 300 mg SC injection on Week 0 (Day 1), self-administered using AI device, on-site under supervision in the parallel arm period of 4 weeks added to LMT.
|
New Auto-Injector Device (Parallel-arm Period)
n=33 participants at risk
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 period of 4 weeks added to LMT.
|
New Auto-Injector Device (Single-arm Period)
n=66 participants at risk
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 at Week 4, 8 and 12 in the single arm treatment period. Duration of single arm treatment period was 12 weeks, i.e. from Week 4 to 16 added to LMT.
|
|---|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.9%
1/34 • Number of events 1 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
0.00%
0/33 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
0.00%
0/66 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/34 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
0.00%
0/33 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/34 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
0.00%
0/66 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Chondritis
|
0.00%
0/34 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
0.00%
0/33 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
Other adverse events
| Measure |
Auto-Injector Device (AI) (Parallel Arm Period)
n=34 participants at risk
Alirocumab 300 mg SC injection on Week 0 (Day 1), self-administered using AI device, on-site under supervision in the parallel arm period of 4 weeks added to LMT.
|
New Auto-Injector Device (Parallel-arm Period)
n=33 participants at risk
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 period of 4 weeks added to LMT.
|
New Auto-Injector Device (Single-arm Period)
n=66 participants at risk
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 at Week 4, 8 and 12 in the single arm treatment period. Duration of single arm treatment period was 12 weeks, i.e. from Week 4 to 16 added to LMT.
|
|---|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/34 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
9.1%
3/33 • Number of events 3 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
0.00%
0/66 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/34 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
0.00%
0/33 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
6.1%
4/66 • Number of events 4 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
2/34 • Number of events 2 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
3.0%
1/33 • Number of events 1 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
1.5%
1/66 • Number of events 1 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/34 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
6.1%
2/33 • Number of events 2 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
4.5%
3/66 • Number of events 3 • All AEs were collected from signature of the informed consent form up to final visit (Week 16) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (the time from first IMP injection to the second IMP injection for participants entering into the single-arm period, or to 70 days after first IMP injection, whichever comes first \[Parallel arm period\] or the time from the second IMP injection up to the day of last IMP injection + 70 days \[Single arm period\]). Analysis was performed on safety population.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Phone: 800-633-1610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER