Trial Outcomes & Findings for Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan (NCT NCT01812707)
NCT ID: NCT01812707
Last Updated: 2016-10-04
Results Overview
Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational product (IP) injection up to 21 days after last IP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward \[LOCF\] method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Baseline to Week 12 (LOCF)
Results posted on
2016-10-04
Participant Flow
The study was conducted at 4 centers in Japan. Overall, 162 participants were screened between March 2013 and August 2013, 62 of whom were run-in/screen failures, mainly due to exclusion criteria met.
Randomization was stratified according to atorvastatin dose. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1:1 ratio after confirmation of selection criteria. 100 participants were randomized.
Participant milestones
| Measure |
Placebo
Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 50 mg Q2W
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 75 mg Q2W
Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 150 mg Q2W
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
25
|
|
Overall Study
Treated
|
25
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
25
|
25
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 50 mg Q2W
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 75 mg Q2W
Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 150 mg Q2W
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
2
|
|
Overall Study
Poor compliance to protocol
|
1
|
0
|
0
|
0
|
|
Overall Study
Consent withdrawn by participant
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan
Baseline characteristics by cohort
| Measure |
Placebo
n=25 Participants
Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 50 mg Q2W
n=25 Participants
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 75 mg Q2W
n=25 Participants
Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 150 mg Q2W
n=25 Participants
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
57.7 years
STANDARD_DEVIATION 10.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Low-Density Lipoprotein Cholesterol (LDL-C) in mmol/L
|
3.13 mmol/L
STANDARD_DEVIATION 0.55 • n=5 Participants
|
3.16 mmol/L
STANDARD_DEVIATION 0.43 • n=7 Participants
|
3.13 mmol/L
STANDARD_DEVIATION 0.43 • n=5 Participants
|
3.12 mmol/L
STANDARD_DEVIATION 0.42 • n=4 Participants
|
3.14 mmol/L
STANDARD_DEVIATION 0.45 • n=21 Participants
|
|
LDL-C in mg/dL
|
121.0 mg/dL
STANDARD_DEVIATION 21.1 • n=5 Participants
|
122.2 mg/dL
STANDARD_DEVIATION 16.6 • n=7 Participants
|
120.9 mg/dL
STANDARD_DEVIATION 16.7 • n=5 Participants
|
120.5 mg/dL
STANDARD_DEVIATION 16.2 • n=4 Participants
|
121.2 mg/dL
STANDARD_DEVIATION 17.5 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12 (LOCF)Population: Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.
Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational product (IP) injection up to 21 days after last IP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward \[LOCF\] method.
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 50 mg Q2W
n=25 Participants
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 75 mg Q2W
n=25 Participants
Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 150 mg Q2W
n=25 Participants
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
|
-2.7 percent change
Standard Error 3.1
|
-54.8 percent change
Standard Error 3.1
|
-62.3 percent change
Standard Error 3.1
|
-71.7 percent change
Standard Error 3.1
|
SECONDARY outcome
Timeframe: Baseline to Week 12 (LOCF)Population: mITT population.
Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 50 mg Q2W
n=25 Participants
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 75 mg Q2W
n=25 Participants
Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 150 mg Q2W
n=25 Participants
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis
|
-0.1 mmol/L
Standard Error 0.1
|
-1.7 mmol/L
Standard Error 0.1
|
-1.9 mmol/L
Standard Error 0.1
|
-2.2 mmol/L
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline to Week 12 (LOCF)Population: mITT population.
Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 50 mg Q2W
n=25 Participants
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 75 mg Q2W
n=25 Participants
Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 150 mg Q2W
n=25 Participants
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis
|
-5.0 mg/dL
Standard Error 3.6
|
-67.1 mg/dL
Standard Error 3.6
|
-74.6 mg/dL
Standard Error 3.6
|
-85.8 mg/dL
Standard Error 3.6
|
SECONDARY outcome
Timeframe: Week 12 (LOCF)Population: mITT population.
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 50 mg Q2W
n=25 Participants
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 75 mg Q2W
n=25 Participants
Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 150 mg Q2W
n=25 Participants
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis
LDL-C <100 mg/dL (2.59 mmol/L)
|
8.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis
LDL-C < 70 mg/dL (1.81 mmol/L)
|
0.0 percentage of participants
|
84.0 percentage of participants
|
84.0 percentage of participants
|
88.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12 (LOCF)Population: Participants of the mITT population with one baseline and at least one post baseline on-treatment value of lipid parameters analyzed.
Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 50 mg Q2W
n=25 Participants
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 75 mg Q2W
n=25 Participants
Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 150 mg Q2W
n=25 Participants
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis
Total Cholesterol
|
-1.2 percent change
Standard Error 2.1
|
-31.9 percent change
Standard Error 2.1
|
-36.3 percent change
Standard Error 2.1
|
-41.4 percent change
Standard Error 2.1
|
|
Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis
HDL-C
|
-0.2 percent change
Standard Error 2.0
|
5.1 percent change
Standard Error 2.0
|
5.0 percent change
Standard Error 2.0
|
3.2 percent change
Standard Error 2.1
|
|
Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis
Non-HDL-C
|
-0.9 percent change
Standard Error 2.9
|
-46.3 percent change
Standard Error 2.9
|
-53.1 percent change
Standard Error 2.9
|
-62.2 percent change
Standard Error 2.9
|
|
Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis
Apo-B
|
-2.3 percent change
Standard Error 3.3
|
-43.5 percent change
Standard Error 3.3
|
-48.6 percent change
Standard Error 3.3
|
-60.0 percent change
Standard Error 3.3
|
SECONDARY outcome
Timeframe: Baseline to Week 12 (LOCF)Population: Participants of the mITT population with one baseline and at least one post baseline on-treatment value of Fasting Triglycerides and Lipoprotein (a) analyzed.
Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (inter-quartile range).
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 50 mg Q2W
n=25 Participants
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 75 mg Q2W
n=25 Participants
Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 150 mg Q2W
n=25 Participants
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis
Fasting Triglycerides
|
1.3 percent change
Interval -13.1 to 22.5
|
-21.1 percent change
Interval -28.2 to 4.2
|
-10.7 percent change
Interval -25.0 to 6.5
|
-15.0 percent change
Interval -24.1 to 0.0
|
|
Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis
Lipoprotein (a)
|
-3.7 percent change
Interval -26.2 to 8.4
|
-35.6 percent change
Interval -52.5 to -7.5
|
-40.2 percent change
Interval -62.9 to -27.4
|
-43.3 percent change
Interval -69.4 to -14.2
|
SECONDARY outcome
Timeframe: From Baseline to Week 12 (LOCF)Population: Participants of the mITT population with one baseline and at least one post baseline on-treatment value of ApoB/ApoA-1 ratio analyzed.
Adjusted LS mean and standard errors were estimated using the same ANCOVA as for primary endpoint.
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 50 mg Q2W
n=25 Participants
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 75 mg Q2W
n=25 Participants
Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 150 mg Q2W
n=25 Participants
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) Ratio at Week 12 - On-Treatment Analysis
|
0.02 ratio
Standard Error 0.02
|
-0.30 ratio
Standard Error 0.02
|
-0.32 ratio
Standard Error 0.02
|
-0.38 ratio
Standard Error 0.02
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Alirocumab 50 mg Q2W
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Alirocumab 75 mg Q2W
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Alirocumab 150 mg Q2W
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=25 participants at risk
Placebo Q2W for 12 weeks in combination with atorvastatin stable dose.
|
Alirocumab 50 mg Q2W
n=25 participants at risk
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 75 mg Q2W
n=25 participants at risk
Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 150 mg Q2W
n=25 participants at risk
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
0.00%
0/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
0.00%
0/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
4.0%
1/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
|
Ear and labyrinth disorders
Vertigo
|
4.0%
1/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
0.00%
0/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
0.00%
0/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
0.00%
0/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
Other adverse events
| Measure |
Placebo
n=25 participants at risk
Placebo Q2W for 12 weeks in combination with atorvastatin stable dose.
|
Alirocumab 50 mg Q2W
n=25 participants at risk
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 75 mg Q2W
n=25 participants at risk
Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
Alirocumab 150 mg Q2W
n=25 participants at risk
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.0%
2/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
24.0%
6/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
24.0%
6/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
16.0%
4/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
|
Infections and infestations
Cystitis
|
4.0%
1/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
0.00%
0/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
0.00%
0/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
8.0%
2/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
8.0%
2/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
0.00%
0/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
4.0%
1/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
|
General disorders
Injection site reaction
|
4.0%
1/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
12.0%
3/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
8.0%
2/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
8.0%
2/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
4.0%
1/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
0.00%
0/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
0.00%
0/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
8.0%
2/25 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants who received at least one dose or partial dose of IMP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER