Trial Outcomes & Findings for Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders (NCT NCT02392559)
NCT ID: NCT02392559
Last Updated: 2022-11-08
Results Overview
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from interactive voice response system \[IVRS\]), scheduled visit and the interaction of treatment with scheduled visit as covariates. The model uses an unstructured covariance.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
158 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2022-11-08
Participant Flow
Participants were enrolled from 24 March 2016 to 30 May 2019 at 8 research centers in North America, 30 research centers in Europe, 6 research centers in Latin America, and 3 research centers in Asia Pacific.
Participants were randomized in a 2:1 ratio to receive 24 weeks of monthly (QM) evolocumab or placebo. Randomization was stratified by screening low-density lipoprotein cholesterol (LDL-C; \< 160 mg/dL vs ≥ 160 mg/dL) and age (\< 14 years vs ≥ 14 years).
Participant milestones
| Measure |
Placebo
Matching subcutaneous injection QM
|
EvoMab 420 mg QM
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
105
|
|
Overall Study
Randomized and Dosed
|
53
|
104
|
|
Overall Study
COMPLETED
|
53
|
104
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Matching subcutaneous injection QM
|
EvoMab 420 mg QM
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
participants with a baseline measurement
Baseline characteristics by cohort
| Measure |
Placebo
n=53 Participants
Matching subcutaneous injection QM
|
EvoMab 420 mg QM
n=104 Participants
Evolocumab subcutaneous injection QM
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.7 years
STANDARD_DEVIATION 2.5 • n=53 Participants
|
13.7 years
STANDARD_DEVIATION 2.3 • n=104 Participants
|
13.7 years
STANDARD_DEVIATION 2.4 • n=157 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=53 Participants
|
61 Participants
n=104 Participants
|
88 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=53 Participants
|
43 Participants
n=104 Participants
|
69 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=53 Participants
|
6 Participants
n=104 Participants
|
13 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=53 Participants
|
98 Participants
n=104 Participants
|
144 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=53 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=53 Participants
|
2 participants
n=104 Participants
|
2 participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Black (or African American)
|
0 participants
n=53 Participants
|
2 participants
n=104 Participants
|
2 participants
n=157 Participants
|
|
Race/Ethnicity, Customized
White
|
44 participants
n=53 Participants
|
89 participants
n=104 Participants
|
133 participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Other, Not Specified
|
9 participants
n=53 Participants
|
11 participants
n=104 Participants
|
20 participants
n=157 Participants
|
|
Stratification Factor: Age Group
< 14 years
|
25 participants
n=53 Participants
|
48 participants
n=104 Participants
|
73 participants
n=157 Participants
|
|
Stratification Factor: Age Group
≥ 14 years
|
28 participants
n=53 Participants
|
56 participants
n=104 Participants
|
84 participants
n=157 Participants
|
|
Stratification Factor: Screening LDL-C Level
< 160 mg/dL
|
16 participants
n=53 Participants
|
33 participants
n=104 Participants
|
49 participants
n=157 Participants
|
|
Stratification Factor: Screening LDL-C Level
≥ 160 mg/dL
|
37 participants
n=53 Participants
|
71 participants
n=104 Participants
|
108 participants
n=157 Participants
|
|
LDL-C
|
183.0 mg/dL
STANDARD_DEVIATION 47.2 • n=53 Participants
|
185.0 mg/dL
STANDARD_DEVIATION 45.0 • n=104 Participants
|
184.3 mg/dL
STANDARD_DEVIATION 45.6 • n=157 Participants
|
|
Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)
|
200.2 mg/dL
STANDARD_DEVIATION 48.2 • n=53 Participants
|
203.8 mg/dL
STANDARD_DEVIATION 47.3 • n=104 Participants
|
202.6 mg/dL
STANDARD_DEVIATION 47.5 • n=157 Participants
|
|
Total Cholesterol/HDL-C Ratio
|
5.517 ratio
STANDARD_DEVIATION 1.492 • n=53 Participants
|
5.702 ratio
STANDARD_DEVIATION 1.791 • n=104 Participants
|
5.639 ratio
STANDARD_DEVIATION 1.694 • n=157 Participants
|
|
Apolipoprotein B (ApoB)
|
119.4 mg/dL
STANDARD_DEVIATION 27.9 • n=51 Participants • participants with a baseline measurement
|
123.3 mg/dL
STANDARD_DEVIATION 27.1 • n=103 Participants • participants with a baseline measurement
|
122.0 mg/dL
STANDARD_DEVIATION 27.3 • n=154 Participants • participants with a baseline measurement
|
|
ApoB/Apolipoprotein A1 (ApoA1) Ratio
|
0.938 ratio
STANDARD_DEVIATION 0.255 • n=51 Participants • participants with a baseline measurement
|
0.970 ratio
STANDARD_DEVIATION 0.302 • n=103 Participants • participants with a baseline measurement
|
0.960 ratio
STANDARD_DEVIATION 0.287 • n=154 Participants • participants with a baseline measurement
|
|
Systolic Blood Pressure
|
112.0 mmHg
STANDARD_DEVIATION 12.1 • n=53 Participants
|
110.8 mmHg
STANDARD_DEVIATION 11.5 • n=104 Participants
|
111.2 mmHg
STANDARD_DEVIATION 11.7 • n=157 Participants
|
|
Diastolic Blood Pressure
|
67.2 mmHg
STANDARD_DEVIATION 8.7 • n=53 Participants
|
66.3 mmHg
STANDARD_DEVIATION 7.7 • n=104 Participants
|
66.6 mmHg
STANDARD_DEVIATION 8.1 • n=157 Participants
|
|
Heart Rate
|
74.3 beats per minute
STANDARD_DEVIATION 11.7 • n=53 Participants
|
74.5 beats per minute
STANDARD_DEVIATION 11.1 • n=104 Participants
|
74.4 beats per minute
STANDARD_DEVIATION 11.2 • n=157 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug.
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from interactive voice response system \[IVRS\]), scheduled visit and the interaction of treatment with scheduled visit as covariates. The model uses an unstructured covariance.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching subcutaneous injection QM
|
EvoMab 420 mg QM
n=104 Participants
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Percent Change From Baseline to Week 24 in LDL-C
|
-6.23 percent change
Standard Error 3.08
|
-44.53 percent change
Standard Error 2.17
|
SECONDARY outcome
Timeframe: Baseline, Week 22, Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug.
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching subcutaneous injection QM
|
EvoMab 420 mg QM
n=104 Participants
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Mean Percent Change From Baseline to Mean of Weeks 22 and 24 in LDL-C
|
-5.87 percent change
Standard Error 2.66
|
-47.95 percent change
Standard Error 1.92
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug.
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching subcutaneous injection QM
|
EvoMab 420 mg QM
n=104 Participants
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Change From Baseline to Week 24 in LDL-C
|
-9.0 mg/dL
Standard Error 6.2
|
-77.5 mg/dL
Standard Error 4.4
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug.
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching subcutaneous injection QM
|
EvoMab 420 mg QM
n=104 Participants
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Percent Change From Baseline to Week 24 in Non-HDL-C
|
-6.14 percent change
Standard Error 2.87
|
-41.19 percent change
Standard Error 2.01
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug.
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching subcutaneous injection QM
|
EvoMab 420 mg QM
n=104 Participants
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Percent Change From Baseline to Week 24 in Apoliprotein-B (ApoB)
|
-2.37 percent change
Standard Error 2.70
|
-34.85 percent change
Standard Error 1.88
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug.
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching subcutaneous injection QM
|
EvoMab 420 mg QM
n=104 Participants
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Percent Change From Baseline to Week 24 in Total Cholesterol/HDL-C Ratio
|
-4.66 percent change
Standard Error 2.60
|
-34.96 percent change
Standard Error 1.82
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug.
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching subcutaneous injection QM
|
EvoMab 420 mg QM
n=104 Participants
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Percent Change From Baseline to Week 24 in ApoB:ApoA1 Ratio
|
-0.63 percent change
Standard Error 2.80
|
-37.02 percent change
Standard Error 1.95
|
SECONDARY outcome
Timeframe: From first dose of study drug up to and including 30 days after the last dose or end of study date (Week 24), whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for Placebo and EvoMab arms, respectively.Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug.
An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have a causal relationship with study treatment. An SAE is defined as an adverse event that: is fatal; is a life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other medically important serious event. Events were graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading scale (1=mild; 2=moderate; 3=severe; 4=life-threatening; 5=death). Events were defined as treatment emergent if they occurred after the first dose of study drug and up to and including 30 days after the last dose or the end of study date, whichever is earlier.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching subcutaneous injection QM
|
EvoMab 420 mg QM
n=104 Participants
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs
All TEAEs
|
34 participants
|
64 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs
Grade ≥ 2 TEAEs
|
22 participants
|
46 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs
Grade ≥ 3 TEAEs
|
0 participants
|
4 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs
Grade ≥ 4 TEAEs
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs
Serious TEAEs
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs
TEAEs Leading to DC of Study Drug
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs
Serious TEAEs Leading to DC of Study Drug
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs
Non-Serious TEAEs Leading to DC of Study Drug
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs
Fatal TEAEs
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs
Device-Related TEAEs
|
2 participants
|
3 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs
Device-Related Grade ≥ 2 TEAEs
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs
Device-Related Grade ≥ 3 TEAEs
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs
Device-Related Grade ≥ 4 TEAEs
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs
Serious Device-Related TEAEs
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug.
Laboratory toxicity grading was based on NCI CTCAE grading. Grade 3 indicates severe toxicity and Grade 4 indicates life-threatening toxicity. Values representing a worsening from baseline are shown.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching subcutaneous injection QM
|
EvoMab 420 mg QM
n=104 Participants
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Number of Participants With Maximum Post-Baseline Laboratory Toxicities of Grade ≥ 3
High Total Bilirubin - Grade 3
|
1 participants
|
0 participants
|
|
Number of Participants With Maximum Post-Baseline Laboratory Toxicities of Grade ≥ 3
High Total Cholesterol - Grade 3
|
1 participants
|
1 participants
|
|
Number of Participants With Maximum Post-Baseline Laboratory Toxicities of Grade ≥ 3
High Uric Acid - Grade 3
|
2 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12, Week 20, Week 22, Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching subcutaneous injection QM
|
EvoMab 420 mg QM
n=104 Participants
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Change From Baseline Over Time in Systolic Blood Pressure
Change at Week 4
|
-0.1 mmHg
Standard Deviation 11.3
|
-0.7 mmHg
Standard Deviation 9.4
|
|
Change From Baseline Over Time in Systolic Blood Pressure
Change at Week 12
|
-0.6 mmHg
Standard Deviation 10.3
|
0.3 mmHg
Standard Deviation 9.6
|
|
Change From Baseline Over Time in Systolic Blood Pressure
Change at Week 20
|
-2.1 mmHg
Standard Deviation 7.7
|
0.1 mmHg
Standard Deviation 10.1
|
|
Change From Baseline Over Time in Systolic Blood Pressure
Change at Week 22
|
1.0 mmHg
Standard Deviation 10.9
|
1.1 mmHg
Standard Deviation 10.0
|
|
Change From Baseline Over Time in Systolic Blood Pressure
Change at Week 24
|
-0.6 mmHg
Standard Deviation 11.4
|
0.6 mmHg
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12, Week 20, Week 22, Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching subcutaneous injection QM
|
EvoMab 420 mg QM
n=104 Participants
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Change From Baseline Over Time in Diastolic Blood Pressure
Change at Week 4
|
-2.5 mmHg
Standard Deviation 9.5
|
-1.5 mmHg
Standard Deviation 7.3
|
|
Change From Baseline Over Time in Diastolic Blood Pressure
Change at Week 12
|
-2.2 mmHg
Standard Deviation 10.0
|
0.5 mmHg
Standard Deviation 8.9
|
|
Change From Baseline Over Time in Diastolic Blood Pressure
Change at Week 20
|
-3.3 mmHg
Standard Deviation 7.6
|
-0.6 mmHg
Standard Deviation 7.7
|
|
Change From Baseline Over Time in Diastolic Blood Pressure
Change at Week 22
|
-1.5 mmHg
Standard Deviation 9.3
|
2.9 mmHg
Standard Deviation 8.0
|
|
Change From Baseline Over Time in Diastolic Blood Pressure
Change at Week 24
|
-0.5 mmHg
Standard Deviation 9.0
|
0.3 mmHg
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12, Week 20, Week 22, Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching subcutaneous injection QM
|
EvoMab 420 mg QM
n=104 Participants
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Change From Baseline Over Time in Heart Rate
Change at Week 20
|
-1.1 beats per minute
Standard Deviation 10.3
|
1.1 beats per minute
Standard Deviation 11.5
|
|
Change From Baseline Over Time in Heart Rate
Change at Week 4
|
2.1 beats per minute
Standard Deviation 11.0
|
0.1 beats per minute
Standard Deviation 10.8
|
|
Change From Baseline Over Time in Heart Rate
Change at Week 12
|
-0.5 beats per minute
Standard Deviation 11.5
|
-1.3 beats per minute
Standard Deviation 10.2
|
|
Change From Baseline Over Time in Heart Rate
Change at Week 22
|
1.3 beats per minute
Standard Deviation 13.5
|
-0.6 beats per minute
Standard Deviation 11.3
|
|
Change From Baseline Over Time in Heart Rate
Change at Week 24
|
0.2 beats per minute
Standard Deviation 13.0
|
-1.8 beats per minute
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: up to Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants receiving evolocumab.
Outcome measures
| Measure |
Placebo
Matching subcutaneous injection QM
|
EvoMab 420 mg QM
n=104 Participants
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Number of Participants Testing Positive for Anti-Evolocumab Antibodies
Binding antibody positive at anytime
|
—
|
0 Participants
|
|
Number of Participants Testing Positive for Anti-Evolocumab Antibodies
Neutralizing antibody positive at anytime
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 12, Week 22, Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.
Outcome measures
| Measure |
Placebo
n=99 Participants
Matching subcutaneous injection QM
|
EvoMab 420 mg QM
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Serum Evolocumab Concentrations Over Time
Week 12
|
22400 ng/mL
Standard Deviation 14700
|
—
|
|
Serum Evolocumab Concentrations Over Time
Week 22
|
64900 ng/mL
Standard Deviation 34400
|
—
|
|
Serum Evolocumab Concentrations Over Time
Week 24
|
25800 ng/mL
Standard Deviation 19200
|
—
|
Adverse Events
Placebo SC QM
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
EvoMab 420 mg SC QM
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo SC QM
n=53 participants at risk
Matching subcutaneous injection QM
|
EvoMab 420 mg SC QM
n=104 participants at risk
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/53 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.96%
1/104 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo SC QM
n=53 participants at risk
Matching subcutaneous injection QM
|
EvoMab 420 mg SC QM
n=104 participants at risk
Evolocumab subcutaneous injection QM
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/53 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.9%
3/104 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/53 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.9%
3/104 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
5.7%
3/53 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.9%
3/104 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
7.5%
4/53 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
4.8%
5/104 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
3.8%
2/53 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.8%
6/104 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
11.3%
6/53 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.5%
12/104 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
3.8%
2/53 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/104 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/53 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.8%
6/104 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.8%
2/53 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.96%
1/104 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
1.9%
1/53 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.6%
11/104 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
3.8%
2/53 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/104 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
3/53 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
2/104 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/53 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
6.7%
7/104 • Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER