Trial Outcomes & Findings for An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (NCT NCT03510884)
NCT ID: NCT03510884
Last Updated: 2023-05-06
Results Overview
Adjusted least square (LS) means and standard errors (SE) were obtained from mixed-effect model with repeated measures (MMRM) model. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
153 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2023-05-06
Participant Flow
Study was conducted at 43 active sites in 24 countries. A total of 203 participants were screened between 31-May-2018 and 31-Jul-2020, of whom 50 were screen failures. Screen failures were mainly due to exclusion criteria met. A total of 153 participants were randomized with a 2:1 ratio to receive study treatment (alirocumab: placebo).
Randomization was stratified according to previous participation (yes or no) in the Phase 2 DFI14223 (NCT02890992) study and Baseline body weight (BW) (less than \[\<\] 50 kilograms (kg) or greater than or equal to \[\>=\] 50 kg).
Participant milestones
| Measure |
Placebo/Alirocumab Q2W
Participants received subcutaneous (SC) injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) every 2 weeks (Q2W) for 24 weeks in double-blind (DB) treatment period added to stable lipid modifying therapy (LMT). After completion of DB treatment period, eligible participants entered into open-label (OL) treatment period and received alirocumab 40 milligrams (mg) (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant low density lipoprotein cholesterol (LDL-C) value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW \<50 kg) or 75 mg to 150 mg (for BW \>=50 kg) or down titrated as 75 mg to 40 mg (for BW \<50 kg) or 150 mg to 75 mg (for BW \>=50 kg).
|
Alirocumab Q2W
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period added to stable LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level was \>=110 milligrams per deciliter (mg/dL) (2.85 millimoles per liter \[mmol/L\]) at Week 8. After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW \<50 kg) or 75 mg to 150 mg (for BW \>=50 kg) or down titrated as 75 mg to 40 mg (for BW \<50 kg) or 150 mg to 75 mg (for BW \>=50 kg).
|
Placebo/Alirocumab Q4W
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) every 4 weeks (Q4W) for 24 weeks in DB treatment period added to stable LMT. After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 150 mg to 300 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 150 mg Q4W to 75 mg Q2W (for BW \<50 kg) or 300 mg Q4W to 150 mg Q2W (for BW \>=50 kg) or down titrated as 75 mg Q2W to 40 mg Q2W (for BW \<50 kg) or 150 mg Q2W to 75 mg Q2W (for BW \>=50 kg).
|
Alirocumab Q4W
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period added to stable LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8. After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 150 mg to 300 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 150 mg Q4W to 75 mg Q2W (for BW \<50 kg) or 300 mg Q4W to 150 mg Q2W (for BW \>=50 kg) or down titrated as 75 mg Q2W to 40 mg Q2W (for BW \<50 kg) or 150 mg Q2W to 75 mg Q2W (for BW \>=50 kg).
|
|---|---|---|---|---|
|
Double-blind Period (up to Week 24)
STARTED
|
25
|
49
|
27
|
52
|
|
Double-blind Period (up to Week 24)
COMPLETED
|
25
|
45
|
26
|
49
|
|
Double-blind Period (up to Week 24)
NOT COMPLETED
|
0
|
4
|
1
|
3
|
|
Open Label Period (up to Week 104)
STARTED
|
25
|
46
|
25
|
49
|
|
Open Label Period (up to Week 104)
COMPLETED
|
22
|
43
|
24
|
49
|
|
Open Label Period (up to Week 104)
NOT COMPLETED
|
3
|
3
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo/Alirocumab Q2W
Participants received subcutaneous (SC) injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) every 2 weeks (Q2W) for 24 weeks in double-blind (DB) treatment period added to stable lipid modifying therapy (LMT). After completion of DB treatment period, eligible participants entered into open-label (OL) treatment period and received alirocumab 40 milligrams (mg) (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant low density lipoprotein cholesterol (LDL-C) value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW \<50 kg) or 75 mg to 150 mg (for BW \>=50 kg) or down titrated as 75 mg to 40 mg (for BW \<50 kg) or 150 mg to 75 mg (for BW \>=50 kg).
|
Alirocumab Q2W
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period added to stable LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level was \>=110 milligrams per deciliter (mg/dL) (2.85 millimoles per liter \[mmol/L\]) at Week 8. After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW \<50 kg) or 75 mg to 150 mg (for BW \>=50 kg) or down titrated as 75 mg to 40 mg (for BW \<50 kg) or 150 mg to 75 mg (for BW \>=50 kg).
|
Placebo/Alirocumab Q4W
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) every 4 weeks (Q4W) for 24 weeks in DB treatment period added to stable LMT. After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 150 mg to 300 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 150 mg Q4W to 75 mg Q2W (for BW \<50 kg) or 300 mg Q4W to 150 mg Q2W (for BW \>=50 kg) or down titrated as 75 mg Q2W to 40 mg Q2W (for BW \<50 kg) or 150 mg Q2W to 75 mg Q2W (for BW \>=50 kg).
|
Alirocumab Q4W
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period added to stable LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8. After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 150 mg to 300 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 150 mg Q4W to 75 mg Q2W (for BW \<50 kg) or 300 mg Q4W to 150 mg Q2W (for BW \>=50 kg) or down titrated as 75 mg Q2W to 40 mg Q2W (for BW \<50 kg) or 150 mg Q2W to 75 mg Q2W (for BW \>=50 kg).
|
|---|---|---|---|---|
|
Double-blind Period (up to Week 24)
Adverse Event
|
0
|
0
|
0
|
2
|
|
Double-blind Period (up to Week 24)
Participant moved
|
0
|
1
|
0
|
0
|
|
Double-blind Period (up to Week 24)
Life events made continuing too difficult
|
0
|
1
|
0
|
0
|
|
Double-blind Period (up to Week 24)
Participant non-compliance to investigational medicinal product (IMP)
|
0
|
2
|
0
|
0
|
|
Double-blind Period (up to Week 24)
Other than specified above
|
0
|
0
|
1
|
1
|
|
Open Label Period (up to Week 104)
Adverse Event
|
1
|
0
|
0
|
0
|
|
Open Label Period (up to Week 104)
Lack of Efficacy
|
0
|
1
|
0
|
0
|
|
Open Label Period (up to Week 104)
Participant moved
|
1
|
0
|
1
|
0
|
|
Open Label Period (up to Week 104)
Life events made continuing too difficult
|
0
|
1
|
0
|
0
|
|
Open Label Period (up to Week 104)
Other than specified above
|
1
|
1
|
0
|
0
|
Baseline Characteristics
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
Baseline characteristics by cohort
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level was \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
Total Title
n=153 Participants
|
|---|---|---|---|---|---|
|
Age, Continuous
|
13.2 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
12.5 years
STANDARD_DEVIATION 2.7 • n=7 Participants
|
12.8 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
13.1 years
STANDARD_DEVIATION 3.0 • n=4 Participants
|
12.9 years
STANDARD_DEVIATION 2.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
125 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Low-Density Lipoprotein Cholesterol (LDL-C)
|
175.29 milligrams/deciliter (mg/dL)
STANDARD_DEVIATION 50.23 • n=5 Participants
|
169.69 milligrams/deciliter (mg/dL)
STANDARD_DEVIATION 46.74 • n=7 Participants
|
176.57 milligrams/deciliter (mg/dL)
STANDARD_DEVIATION 49.01 • n=5 Participants
|
176.79 milligrams/deciliter (mg/dL)
STANDARD_DEVIATION 53.93 • n=4 Participants
|
174.23 milligrams/deciliter (mg/dL)
STANDARD_DEVIATION 49.85 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on ITT population which included all randomized participants who were analyzed according to the treatment group allocated by randomization. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Adjusted least square (LS) means and standard errors (SE) were obtained from mixed-effect model with repeated measures (MMRM) model. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=50 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24: Intent-to-treat (ITT) Estimand
|
9.7 percent change
Standard Error 4.3
|
-33.6 percent change
Standard Error 3.4
|
-4.4 percent change
Standard Error 3.7
|
-38.2 percent change
Standard Error 4.0
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=50 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12: ITT Estimand
|
10.7 percent change
Standard Error 3.6
|
-34.8 percent change
Standard Error 3.0
|
2.3 percent change
Standard Error 3.6
|
-39.2 percent change
Standard Error 3.3
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=47 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=49 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24: ITT Estimand
|
10.4 percent change
Standard Error 2.8
|
-27.4 percent change
Standard Error 3.2
|
-3.6 percent change
Standard Error 3.9
|
-34.3 percent change
Standard Error 2.9
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=50 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24: ITT Estimand
|
9.7 percent change
Standard Error 3.9
|
-31.0 percent change
Standard Error 3.2
|
-3.7 percent change
Standard Error 4.0
|
-35.6 percent change
Standard Error 3.5
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=50 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24: ITT Estimand
|
7.4 percent change
Standard Error 3.0
|
-23.4 percent change
Standard Error 2.5
|
-4.4 percent change
Standard Error 3.3
|
-27.7 percent change
Standard Error 2.9
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=47 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=49 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Apolipoprotein B at Week 12: ITT Estimand
|
8.9 percent change
Standard Error 3.1
|
-30.0 percent change
Standard Error 2.5
|
1.1 percent change
Standard Error 3.2
|
-31.7 percent change
Standard Error 2.9
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=50 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 12: ITT Estimand
|
9.8 percent change
Standard Error 3.8
|
-33.0 percent change
Standard Error 2.8
|
2.8 percent change
Standard Error 3.5
|
-34.7 percent change
Standard Error 2.9
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=50 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Total Cholesterol at Week 12: ITT Estimand
|
7.5 percent change
Standard Error 2.9
|
-25.3 percent change
Standard Error 2.2
|
0.9 percent change
Standard Error 2.5
|
-27.0 percent change
Standard Error 2.3
|
SECONDARY outcome
Timeframe: At Week 24Population: Analysis was performed on ITT population.
Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data up to Week 24 were included in the imputation model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol Level Lower Than (<) 130 mg/dL (3.37 mmol/L) at Week 24: ITT Estimand
|
8.0 percentage of participants
|
73.3 percentage of participants
|
22.2 percentage of participants
|
76.3 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 12Population: Analysis was performed on ITT population.
Adjusted percentages at Week 12 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data up to Week 12 were included in the imputation model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol Level <130 mg/dL (3.37 mmol/L) at Week 12: ITT Estimand
|
16.4 percentage of participants
|
70.6 percentage of participants
|
12.9 percentage of participants
|
72.6 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 24Population: Analysis was performed on ITT population.
Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data up to Week 24 were included in the imputation model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants Achieving Low Density Lipoprotein Cholesterol <110 mg/dL (2.84 mmol/L) at Week 24: ITT Estimand
|
4.0 percentage of participants
|
57.2 percentage of participants
|
9.0 percentage of participants
|
67.2 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 12Population: Analysis was performed on ITT population.
Adjusted percentages at Week 12 were obtained from multiple imputation approach for handling of missing data for Q4W. All available post-baseline data up to Week 12 were included in the imputation model. For Q2W, adjusted percentages at Week 12 were obtained from last observation carried forward approach (LOCF) to handle missing on-treatment LDL-C values as well as missing post-treatment LDL-C values in participants who discontinued treatment due to the coronavirus disease-2019 pandemic. Other post-treatment missing values were considered as failure.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants Achieving Low Density Lipoprotein Cholesterol <110 mg/dL (2.84 mmol/L) at Week 12: ITT Estimand
|
0.0 percentage of participants
|
61.2 percentage of participants
|
4.3 percentage of participants
|
57.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on ITT population.
Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline data up to Week 24. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Lipoprotein (a) at Week 24: ITT Estimand
|
0.5 percent change
Standard Error 5.3
|
-14.7 percent change
Standard Error 4.1
|
2.5 percent change
Standard Error 7.1
|
-22.4 percent change
Standard Error 5.0
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on ITT population.
Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline data up to Week 12. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Lipoprotein (a) at Week 12: ITT Estimand
|
-7.1 percent change
Standard Error 5.9
|
-12.7 percent change
Standard Error 3.9
|
-2.5 percent change
Standard Error 6.9
|
-16.0 percent change
Standard Error 5.1
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=50 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 24: ITT Estimand
|
-0.8 percent change
Standard Error 2.1
|
5.6 percent change
Standard Error 1.4
|
-1.1 percent change
Standard Error 2.7
|
3.4 percent change
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on ITT population.
Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline data up to Week 24. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Fasting Triglycerides (TG) at Week 24: ITT Estimand
|
7.7 percent change
Standard Error 8.4
|
11.9 percent change
Standard Error 6.3
|
12.2 percent change
Standard Error 8.2
|
-6.8 percent change
Standard Error 5.5
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=47 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=49 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Apolipoprotein A1 (Apo A1) at Week 24: ITT Estimand
|
-0.1 percent change
Standard Error 2.6
|
1.0 percent change
Standard Error 1.5
|
-4.5 percent change
Standard Error 2.6
|
4.4 percent change
Standard Error 2.0
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=50 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in High-Density Lipoprotein Cholesterol at Week 12: ITT Estimand
|
-2.2 percent change
Standard Error 3.2
|
3.5 percent change
Standard Error 2.0
|
-3.5 percent change
Standard Error 3.2
|
4.0 percent change
Standard Error 2.2
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on ITT population.
Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline data up to Week 12. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12: ITT Estimand
|
6.5 percent change
Standard Error 7.4
|
-2.2 percent change
Standard Error 5.0
|
7.8 percent change
Standard Error 8.4
|
-0.3 percent change
Standard Error 6.0
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=47 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=49 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Apolipoprotein A1 at Week 12: ITT Estimand
|
-0.1 percent change
Standard Error 1.8
|
-1.7 percent change
Standard Error 1.7
|
-0.7 percent change
Standard Error 3.1
|
5.0 percent change
Standard Error 1.7
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, and 24Population: Analysis was performed on modified intent-to-treat (mITT) population which included all randomized participants who took at least one dose or part of a dose of the IMP injection. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st investigational medicinal product (IMP) injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=50 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Weeks 12, and 24: On-treatment Estimand
Week 12
|
10.7 percent change
Standard Error 3.6
|
-34.8 percent change
Standard Error 3.0
|
2.3 percent change
Standard Error 3.6
|
-39.2 percent change
Standard Error 3.3
|
|
DB Period: Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Weeks 12, and 24: On-treatment Estimand
Week 24
|
9.7 percent change
Standard Error 4.3
|
-33.6 percent change
Standard Error 3.4
|
-4.4 percent change
Standard Error 3.7
|
-38.2 percent change
Standard Error 4.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=47 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=49 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Apolipoprotein B at Weeks 12 and 24: On-treatment Estimand
Week 12
|
8.9 percent change
Standard Error 3.1
|
-30.0 percent change
Standard Error 2.5
|
1.1 percent change
Standard Error 3.2
|
-31.7 percent change
Standard Error 2.9
|
|
DB Period: Percent Change From Baseline in Apolipoprotein B at Weeks 12 and 24: On-treatment Estimand
Week 24
|
10.4 percent change
Standard Error 2.8
|
-27.4 percent change
Standard Error 3.2
|
-3.6 percent change
Standard Error 3.9
|
-34.3 percent change
Standard Error 2.9
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=50 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Weeks 12 and 24: On-treatment Estimand
Week 12
|
9.8 percent change
Standard Error 3.8
|
-33.0 percent change
Standard Error 2.8
|
2.8 percent change
Standard Error 3.5
|
-34.7 percent change
Standard Error 2.9
|
|
DB Period: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Weeks 12 and 24: On-treatment Estimand
Week 24
|
9.7 percent change
Standard Error 3.9
|
-31.0 percent change
Standard Error 3.2
|
-3.7 percent change
Standard Error 4.0
|
-35.6 percent change
Standard Error 3.5
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=50 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Total Cholesterol at Weeks 12 and 24: On-treatment Estimand
Week 12
|
7.5 percent change
Standard Error 2.9
|
-25.3 percent change
Standard Error 2.2
|
0.9 percent change
Standard Error 2.5
|
-27.0 percent change
Standard Error 2.3
|
|
DB Period: Percent Change From Baseline in Total Cholesterol at Weeks 12 and 24: On-treatment Estimand
Week 24
|
7.4 percent change
Standard Error 3.0
|
-23.4 percent change
Standard Error 2.5
|
-4.4 percent change
Standard Error 3.3
|
-27.7 percent change
Standard Error 2.9
|
SECONDARY outcome
Timeframe: Weeks 12 and 24Population: Analysis was performed on mITT population.
Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol < 130 mg/dL (3.37 mmol/L) at Weeks 12 and 24: On-treatment Estimand
Week 12
|
16.4 percentage of participants
|
70.6 percentage of participants
|
12.9 percentage of participants
|
72.6 percentage of participants
|
|
DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol < 130 mg/dL (3.37 mmol/L) at Weeks 12 and 24: On-treatment Estimand
Week 24
|
8.0 percentage of participants
|
73.3 percentage of participants
|
22.2 percentage of participants
|
76.3 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 12 and 24Population: Analysis was performed on mITT population.
Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol < 110 mg/dL (2.84 mmol/L) at Weeks 12 and 24: On-treatment Estimand
Week 12
|
0.1 percentage of participants
|
61.7 percentage of participants
|
4.3 percentage of participants
|
57.0 percentage of participants
|
|
DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol < 110 mg/dL (2.84 mmol/L) at Weeks 12 and 24: On-treatment Estimand
Week 24
|
4.0 percentage of participants
|
57.2 percentage of participants
|
9.0 percentage of participants
|
67.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Analysis was performed on mITT population.
Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline on-treatment data up to Week 12 and Week 24, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Lipoprotein (a) at Weeks 12 and 24: On-treatment Estimand
Week 12
|
-7.099 percent change
Standard Error 5.923
|
-12.746 percent change
Standard Error 3.889
|
-2.545 percent change
Standard Error 6.851
|
-16.042 percent change
Standard Error 5.139
|
|
DB Period: Percent Change From Baseline in Lipoprotein (a) at Weeks 12 and 24: On-treatment Estimand
Week 24
|
0.492 percent change
Standard Error 5.254
|
-14.748 percent change
Standard Error 4.083
|
2.468 percent change
Standard Error 7.135
|
-22.418 percent change
Standard Error 5.030
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM mode, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=47 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=49 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Apolipoprotein A1 at Weeks 12 and 24: On-treatment Estimand
Week 12
|
-0.1 percent change
Standard Error 1.8
|
-1.7 percent change
Standard Error 1.7
|
-0.7 percent change
Standard Error 3.1
|
5.0 percent change
Standard Error 1.7
|
|
DB Period: Percent Change From Baseline in Apolipoprotein A1 at Weeks 12 and 24: On-treatment Estimand
Week 24
|
-0.1 percent change
Standard Error 2.6
|
1.0 percent change
Standard Error 1.5
|
-4.5 percent change
Standard Error 2.6
|
4.4 percent change
Standard Error 2.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, and 24Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 day otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=50 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24: On-treatment Estimand
Week 12
|
-2.2 percent change
Standard Error 3.2
|
3.5 percent change
Standard Error 2.0
|
-3.5 percent change
Standard Error 3.2
|
4.0 percent change
Standard Error 2.2
|
|
DB Period: Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24: On-treatment Estimand
Week 24
|
-0.8 percent change
Standard Error 2.1
|
5.6 percent change
Standard Error 1.4
|
-1.1 percent change
Standard Error 2.7
|
3.4 percent change
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, and 24Population: Analysis was performed on mITT population.
Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline on-treatment data up to Week 12 and Week 24, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change From Baseline in Fasting Triglycerides at Weeks 12 and 24: On-treatment Estimand
Week 12
|
6.5 percent change
Standard Error 7.4
|
-2.2 percent change
Standard Error 5.0
|
7.8 percent change
Standard Error 8.4
|
-0.3 percent change
Standard Error 6.0
|
|
DB Period: Percent Change From Baseline in Fasting Triglycerides at Weeks 12 and 24: On-treatment Estimand
Week 24
|
7.7 percent change
Standard Error 8.4
|
11.9 percent change
Standard Error 6.3
|
12.2 percent change
Standard Error 8.2
|
-6.8 percent change
Standard Error 5.5
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, and 24Population: Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 12 and Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=47 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=49 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 12 and 24: ITT Estimand
Week 12
|
0.1 ratio (Apo B/Apo A-1)
Standard Error 0.0
|
-0.2 ratio (Apo B/Apo A-1)
Standard Error 0.0
|
0.0 ratio (Apo B/Apo A-1)
Standard Error 0.0
|
-0.3 ratio (Apo B/Apo A-1)
Standard Error 0.0
|
|
DB Period: Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 12 and 24: ITT Estimand
Week 24
|
0.1 ratio (Apo B/Apo A-1)
Standard Error 0.0
|
-0.2 ratio (Apo B/Apo A-1)
Standard Error 0.0
|
0.0 ratio (Apo B/Apo A-1)
Standard Error 0.0
|
-0.3 ratio (Apo B/Apo A-1)
Standard Error 0.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, and 24Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=47 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=49 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 12 and 24: On-treatment Estimand
Week 12
|
0.1 ratio (Apo B/Apo A-1)
Standard Error 0.0
|
-0.2 ratio (Apo B/Apo A-1)
Standard Error 0.0
|
0.0 ratio (Apo B/Apo A-1)
Standard Error 0.0
|
-0.3 ratio (Apo B/Apo A-1)
Standard Error 0.0
|
|
DB Period: Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 12 and 24: On-treatment Estimand
Week 24
|
0.1 ratio (Apo B/Apo A-1)
Standard Error 0.0
|
-0.2 ratio (Apo B/Apo A-1)
Standard Error 0.0
|
0.0 ratio (Apo B/Apo A-1)
Standard Error 0.0
|
-0.3 ratio (Apo B/Apo A-1)
Standard Error 0.0
|
SECONDARY outcome
Timeframe: At Weeks 12 and 24Population: Analysis was performed on ITT population.
Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants Who Achieved at Least 30 Percent (%) Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: ITT Estimand
Week12
|
0.8 percentage of participants
|
65.8 percentage of participants
|
4.2 percentage of participants
|
70.8 percentage of participants
|
|
DB Period: Percentage of Participants Who Achieved at Least 30 Percent (%) Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: ITT Estimand
Week 24
|
4.0 percentage of participants
|
66.7 percentage of participants
|
18.5 percentage of participants
|
72.5 percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 12 and 24Population: Analysis was performed on mITT population.
Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants Achieved at Least 30% Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: On-treatment Estimand
Week 12
|
0.8 percentage of participants
|
65.8 percentage of participants
|
4.2 percentage of participants
|
70.8 percentage of participants
|
|
DB Period: Percentage of Participants Achieved at Least 30% Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: On-treatment Estimand
Week 24
|
4.0 percentage of participants
|
66.7 percentage of participants
|
18.5 percentage of participants
|
72.5 percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 12 and 24Population: Analysis was performed on ITT population.
Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants Who Achieved at Least 50% Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: ITT Estimand
Week 12
|
0.0 percentage of participants
|
25.2 percentage of participants
|
0.1 percentage of participants
|
31.9 percentage of participants
|
|
DB Period: Percentage of Participants Who Achieved at Least 50% Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: ITT Estimand
Week 24
|
0.0 percentage of participants
|
21.6 percentage of participants
|
9.1 percentage of participants
|
32.4 percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 12 and 24Population: Analysis was performed on mITT population.
Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants Who Achieved at Least 50% Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: On-treatment Estimand
Week 24
|
0.0 percentage of participants
|
21.6 percentage of participants
|
9.1 percentage of participants
|
32.4 percentage of participants
|
|
DB Period: Percentage of Participants Who Achieved at Least 50% Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: On-treatment Estimand
Week 12
|
0.0 percentage of participants
|
25.2 percentage of participants
|
0.1 percentage of participants
|
31.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 8, 12 and 24Population: Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 8, Week 12 and Week 24 were used and missing data were accounted for by the MMRM model.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=50 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Weeks 8, 12 and 24: ITT Estimand
Week 24
|
9.7 percent change
Standard Error 4.3
|
-33.6 percent change
Standard Error 3.4
|
-4.4 percent change
Standard Error 3.7
|
-38.2 percent change
Standard Error 4.0
|
|
DB Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Weeks 8, 12 and 24: ITT Estimand
Week 8
|
7.1 percent change
Standard Error 4.2
|
-35.4 percent change
Standard Error 3.6
|
-3.8 percent change
Standard Error 3.5
|
-42.0 percent change
Standard Error 2.8
|
|
DB Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Weeks 8, 12 and 24: ITT Estimand
Week 12
|
10.7 percent change
Standard Error 3.6
|
-34.8 percent change
Standard Error 3.0
|
2.3 percent change
Standard Error 3.6
|
-39.2 percent change
Standard Error 3.3
|
SECONDARY outcome
Timeframe: Baseline to Weeks 8, 12 and 24Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. .
Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 8, Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=50 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Weeks 8, 12 and 24: On-treatment Estimand
Week 8
|
7.1 percent change
Standard Error 4.2
|
-35.4 percent change
Standard Error 3.6
|
-3.8 percent change
Standard Error 3.5
|
-42.0 percent change
Standard Error 2.8
|
|
DB Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Weeks 8, 12 and 24: On-treatment Estimand
Week 12
|
10.7 percent change
Standard Error 3.6
|
-34.8 percent change
Standard Error 3.0
|
2.3 percent change
Standard Error 3.6
|
-39.2 percent change
Standard Error 3.3
|
|
DB Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Weeks 8, 12 and 24: On-treatment Estimand
Week 24
|
9.7 percent change
Standard Error 4.3
|
-33.6 percent change
Standard Error 3.4
|
-4.4 percent change
Standard Error 3.7
|
-38.2 percent change
Standard Error 4.0
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. The IIT estimand was analyzed by considering all the post-baseline (including both on- and post-treatment) LDL-C values for the analysis. .
Percent Change in LDL-C from Baseline to Week 104 was reported in this outcome measure.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=45 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=23 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=47 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
OL Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Week 104: ITT Estimand
|
-23.3 percent change
Standard Error 4.9
|
-22.2 percent change
Standard Error 5.6
|
-27.1 percent change
Standard Error 7.0
|
-23.7 percent change
Standard Error 4.2
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. The on-treatment estimand was analyzed using the same imputation model as ITT Estimand, but considered the 'on-treatment' LDL-C values alone for the analysis.
Percent Change in LDL-C from Baseline to Week 104 was reported in this outcome measure.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=45 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=23 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=47 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
OL Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Week 104: On-treatment Estimand
|
-22.8 percent change
Standard Error 5.1
|
-25.8 percent change
Standard Error 4.9
|
-27.6 percent change
Standard Error 7.6
|
-23.4 percent change
Standard Error 4.7
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24, 68 and 104Population: Analysis was performed on safety population which consisted of the randomized population who had actually received at least one dose or partial dose of IMP. Here, number analyzed = participants with available data for each specified category.
Cogstate battery test (cognitive testing system) consisted of detection test (DET), identification test (IDN), one card learning test (OCL) and Groton maze learning test (GML) to assess processing speed, attention, visual learning and executive functioning, respectively. For each test, Z-scores were computed based on participant's age at Baseline and Weeks 24, 68 and 104. Composite score: calculated as mean of Z-scores equally weighted, provided that at least 3 of 4 tests were available and if all of these domains were covered as: attention, through either DET or IDN, visual learning, through OCL and executive function, through GML. There is not minimum/maximum since values were reported as z-score but z-score of 0 means result equals to mean with negative numbers indicating values lower than mean and positive values higher. Positive change in z-score = an improvement in cognition, i.e., a better outcome; and negative change in z-score = worsening in cognition, i.e., a worse outcome.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
Change From Baseline in Cogstate Battery Test - Overall Composite Score at Weeks 24, 68 and 104
Week 24
|
-0.403 Z-score
Standard Deviation 1.008
|
-0.313 Z-score
Standard Deviation 0.444
|
-0.218 Z-score
Standard Deviation 0.501
|
-0.136 Z-score
Standard Deviation 0.637
|
|
Change From Baseline in Cogstate Battery Test - Overall Composite Score at Weeks 24, 68 and 104
Week 68
|
-0.421 Z-score
Standard Deviation 1.752
|
-0.334 Z-score
Standard Deviation 0.912
|
-0.272 Z-score
Standard Deviation 0.814
|
-0.263 Z-score
Standard Deviation 0.717
|
|
Change From Baseline in Cogstate Battery Test - Overall Composite Score at Weeks 24, 68 and 104
Week 104
|
-0.601 Z-score
Standard Deviation 1.612
|
-0.439 Z-score
Standard Deviation 0.917
|
-0.393 Z-score
Standard Deviation 0.764
|
-0.638 Z-score
Standard Deviation 0.791
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24, 68 and 104Population: Analysis was performed on safety population. Here, number analyzed = participants with available data for each specified category.
Tanner stage defines physical measurements of development in children and adolescent based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males) and classified in 3 categories as: Prepubescent (defined as a person just before start of the development of adult sexual characteristics), Pubescent (defined as a person at or approaching the age of puberty), Postpubescent (sexually mature or a person who has completed puberty).
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Baseline: Boys - Prepubescent
|
1 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Baseline: Boys - Pubescent
|
13 Participants
|
13 Participants
|
4 Participants
|
14 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Baseline: Boys - Postpubescent
|
3 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Baseline: Girls - Prepubescent
|
1 Participants
|
4 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Baseline: Girls - Pubescent
|
6 Participants
|
16 Participants
|
8 Participants
|
13 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Baseline: Girls - Postpubescent
|
1 Participants
|
10 Participants
|
6 Participants
|
14 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 24: Boys - Prepubescent
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 24: Boys - Pubescent
|
13 Participants
|
11 Participants
|
7 Participants
|
12 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 24: Boys - Postpubescent
|
4 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 24: Girls - Prepubescent
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 24: Girls - Pubescent
|
5 Participants
|
15 Participants
|
6 Participants
|
16 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 24: Girls - Postpubescent
|
2 Participants
|
9 Participants
|
5 Participants
|
9 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 68: Boys - Prepubescent
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 68: Boys - Pubescent
|
7 Participants
|
9 Participants
|
5 Participants
|
9 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 68: Boys - Postpubescent
|
4 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 68: Girls - Prepubescent
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 68: Girls - Pubescent
|
6 Participants
|
14 Participants
|
5 Participants
|
16 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 68: Girls - Postpubescent
|
1 Participants
|
9 Participants
|
5 Participants
|
9 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 104: Boys - Prepubescent
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 104: Boys - Pubescent
|
6 Participants
|
8 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 104: Boys - Postpubescent
|
7 Participants
|
6 Participants
|
2 Participants
|
7 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 104: Girls - Prepubescent
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 104: Girls - Pubescent
|
4 Participants
|
10 Participants
|
5 Participants
|
17 Participants
|
|
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Week 104: Girls - Postpubescent
|
2 Participants
|
11 Participants
|
5 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Analysis was performed on ADA population which included all randomized and treated (who actually received at least one dose or part of a dose of the IMP injection) participants with an available ADA sample at Baseline (Week 0) and at least 1 non-missing ADA sample post first IMP injection and up to Week 24/early termination. Here, 'number analyzed' = participants with available data for each specified category and '0' in number analyzed filed signifies that no participants were evaluable.
Anti-drug (alirocumab) antibodies samples were analyzed using a validated non-quantitative, titer-based bridging immunoassay. Number of participants with positive ADA during 24-week treatment period is reported. Treatment-emergent positive ADA response was 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. A persistent positive response was defined as a TE ADA positive response detected in at least 2 consecutive post-baseline samples separated by at least a 12-week period. Persistent positive response was only analyzed for participants with positive TE ADA response.
Outcome measures
| Measure |
DB Period: Placebo Q2W
n=25 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=48 Participants
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=26 Participants
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=49 Participants
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
|---|---|---|---|---|
|
DB Period: Number of Participants With Treatment-Emergent (TE) Positive Anti-Alirocumab Antibodies (ADA) Response
TE ADA positive response
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
DB Period: Number of Participants With Treatment-Emergent (TE) Positive Anti-Alirocumab Antibodies (ADA) Response
Persistent positive response
|
—
|
0 Participants
|
—
|
—
|
Adverse Events
DB Period: Placebo Q2W
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
DB Period: Alirocumab Q2W
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
DB Period: Placebo Q4W
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
DB Period: Alirocumab Q4W
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
OL Period: Placebo/Alirocumab Q2W
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
OL Period: Alirocumab Q2W
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
OL Period: Placebo/Alirocumab Q4W
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
OL Period: Alirocumab Q4W
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB Period: Placebo Q2W
n=25 participants at risk
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 participants at risk
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 participants at risk
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 participants at risk
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
OL Period: Placebo/Alirocumab Q2W
n=25 participants at risk
After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW \<50 kg) or 75 mg to 150 mg (for BW \>=50 kg) or down titrated as 75 mg to 40 mg (for BW \<50 kg) or 150 mg to 75 mg (for BW \>=50 kg).
|
OL Period: Alirocumab Q2W
n=46 participants at risk
After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW \<50 kg) or 75 mg to 150 mg (for BW \>=50 kg) or down titrated as 75 mg to 40 mg (for BW \<50 kg) or 150 mg to 75 mg (for BW \>=50 kg).
|
OL Period: Placebo/Alirocumab Q4W
n=25 participants at risk
After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 150 mg to 300 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 150 mg Q4W to 75 mg Q2W (for BW \<50 kg) or 300 mg Q4W to 150 mg Q2W (for BW \>=50 kg) or down titrated as 75 mg Q2W to 40 mg Q2W (for BW \<50 kg) or 150 mg Q2W to 75 mg Q2W (for BW \>=50 kg).
|
OL Period: Alirocumab Q4W
n=49 participants at risk
After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 150 mg to 300 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 150 mg Q4W to 75 mg Q2W (for BW \<50 kg) or 300 mg Q4W to 150 mg Q2W (for BW \>=50 kg) or down titrated as 75 mg Q2W to 40 mg Q2W (for BW \<50 kg) or 150 mg Q2W to 75 mg Q2W (for BW \>=50 kg).
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
2.2%
1/46 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Infections and infestations
Appendicitis
|
4.0%
1/25 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/46 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
4.0%
1/25 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
2.2%
1/46 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
2.0%
1/49 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/46 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Nervous system disorders
Syncope
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
3.8%
2/52 • Number of events 2 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/46 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
4.0%
1/25 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
2.0%
1/49 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/46 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
2.0%
1/49 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/46 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
2.0%
1/49 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Vascular disorders
Hypertension
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
2.2%
1/46 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
2.0%
1/49 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/46 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
2.0%
1/49 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/46 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Musculoskeletal and connective tissue disorders
Sympathetic Posterior Cervical Syndrome
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
2.0%
1/49 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/46 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
2.2%
1/46 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
3.7%
1/27 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/46 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/46 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
2.0%
1/49 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
Other adverse events
| Measure |
DB Period: Placebo Q2W
n=25 participants at risk
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q2W
n=49 participants at risk
Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
DB Period: Placebo Q4W
n=27 participants at risk
Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT.
|
DB Period: Alirocumab Q4W
n=52 participants at risk
Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8.
|
OL Period: Placebo/Alirocumab Q2W
n=25 participants at risk
After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW \<50 kg) or 75 mg to 150 mg (for BW \>=50 kg) or down titrated as 75 mg to 40 mg (for BW \<50 kg) or 150 mg to 75 mg (for BW \>=50 kg).
|
OL Period: Alirocumab Q2W
n=46 participants at risk
After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW \<50 kg) or 75 mg to 150 mg (for BW \>=50 kg) or down titrated as 75 mg to 40 mg (for BW \<50 kg) or 150 mg to 75 mg (for BW \>=50 kg).
|
OL Period: Placebo/Alirocumab Q4W
n=25 participants at risk
After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 150 mg to 300 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 150 mg Q4W to 75 mg Q2W (for BW \<50 kg) or 300 mg Q4W to 150 mg Q2W (for BW \>=50 kg) or down titrated as 75 mg Q2W to 40 mg Q2W (for BW \<50 kg) or 150 mg Q2W to 75 mg Q2W (for BW \>=50 kg).
|
OL Period: Alirocumab Q4W
n=49 participants at risk
After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 150 mg to 300 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 150 mg Q4W to 75 mg Q2W (for BW \<50 kg) or 300 mg Q4W to 150 mg Q2W (for BW \>=50 kg) or down titrated as 75 mg Q2W to 40 mg Q2W (for BW \<50 kg) or 150 mg Q2W to 75 mg Q2W (for BW \>=50 kg).
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Covid-19
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
2.2%
1/46 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
4.0%
1/25 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
8.2%
4/49 • Number of events 5 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
2/25 • Number of events 2 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
14.3%
7/49 • Number of events 7 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
7.4%
2/27 • Number of events 2 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
1.9%
1/52 • Number of events 4 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
8.0%
2/25 • Number of events 2 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
6.5%
3/46 • Number of events 5 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
4.0%
1/25 • Number of events 2 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
6.1%
3/49 • Number of events 5 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Infections and infestations
Tonsillitis
|
4.0%
1/25 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
6.1%
3/49 • Number of events 3 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
3.7%
1/27 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/46 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
12.0%
3/25 • Number of events 3 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
6.1%
3/49 • Number of events 3 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
11.1%
3/27 • Number of events 3 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
5.8%
3/52 • Number of events 3 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
8.0%
2/25 • Number of events 2 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
4.3%
2/46 • Number of events 4 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
4.1%
2/49 • Number of events 3 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • Number of events 2 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
6.1%
3/49 • Number of events 3 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
3.7%
1/27 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
7.7%
4/52 • Number of events 5 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
4.0%
1/25 • Number of events 6 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
10.9%
5/46 • Number of events 5 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
16.0%
4/25 • Number of events 5 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
14.3%
7/49 • Number of events 15 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Nervous system disorders
Migraine
|
8.0%
2/25 • Number of events 3 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
1.9%
1/52 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/46 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
8.7%
4/46 • Number of events 4 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
7.4%
2/27 • Number of events 3 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/46 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
8.0%
2/25 • Number of events 2 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/46 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
2.0%
1/49 • Number of events 2 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
General disorders
Injection Site Reaction
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
6.1%
3/49 • Number of events 12 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
3.8%
2/52 • Number of events 3 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
4.0%
1/25 • Number of events 2 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
6.5%
3/46 • Number of events 17 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
4.0%
1/25 • Number of events 2 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
2.0%
1/49 • Number of events 1 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
|
Investigations
Low Density Lipoprotein Decreased
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/49 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/27 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/52 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
8.0%
2/25 • Number of events 2 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/46 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
0.00%
0/25 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
4.1%
2/49 • Number of events 2 • For the DB period: for participants proceeding into the OL treatment period, from first DB IMP dose up to the day before first OL IMP dose ( i.e., up to Week 24); and for participants not proceeding into the OL treatment period, from first DB IMP dose up to Week 24 + 10 weeks (i.e., up to Week 34); for the OL period: from first OL IMP dose up to 10 weeks after the last OL IMP dose (i.e., up to Week 112)
Reported AEs were AEs which developed, worsened/became serious in each of the study periods, i.e. DB and OL, respectively.
|
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