Trial Outcomes & Findings for Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia (NCT NCT01288469)
NCT ID: NCT01288469
Last Updated: 2015-09-24
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 8 data were imputed by last observation carried forward \[LOCF\] method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
From Baseline to Week 8 (LOCF)
Results posted on
2015-09-24
Participant Flow
The study was conducted at 20 centers in the United States of America. Overall, 214 participants were screened between January 2011 and April 2011. Screen failures were mainly due to exclusion criteria met.
Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1 ratio after confirmation of selection criteria. 92 participants were randomized.
Participant milestones
| Measure |
Placebo + Atorvastatin 80 mg
Placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 10 mg
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 80 mg
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
30
|
|
Overall Study
Treated
|
31
|
31
|
30
|
|
Overall Study
COMPLETED
|
24
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
2
|
Reasons for withdrawal
| Measure |
Placebo + Atorvastatin 80 mg
Placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 10 mg
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 80 mg
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
1
|
|
Overall Study
Poor compliance to protocol
|
0
|
1
|
0
|
|
Overall Study
Participant Moved
|
1
|
0
|
0
|
|
Overall Study
Consent withdrawn by subject
|
1
|
1
|
1
|
|
Overall Study
Exclusion criteria finally met
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia
Baseline characteristics by cohort
| Measure |
Placebo + Atorvastatin 80 mg
n=31 Participants
Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 10 mg
n=31 Participants
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 80 mg
n=30 Participants
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
57.9 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Low-Density Lipoprotein Cholesterol (LDL-C) in mmol/L
|
3.138 mmol/L
STANDARD_DEVIATION 0.469 • n=5 Participants
|
3.101 mmol/L
STANDARD_DEVIATION 0.402 • n=7 Participants
|
3.288 mmol/L
STANDARD_DEVIATION 0.564 • n=5 Participants
|
3.174 mmol/L
STANDARD_DEVIATION 0.484 • n=4 Participants
|
|
LDL-C in mg/dL
|
121.2 mg/dL
STANDARD_DEVIATION 18.1 • n=5 Participants
|
119.7 mg/dL
STANDARD_DEVIATION 15.5 • n=7 Participants
|
126.9 mg/dL
STANDARD_DEVIATION 21.8 • n=5 Participants
|
122.6 mg/dL
STANDARD_DEVIATION 18.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 8 (LOCF)Population: Modified Intent-To-Treat (mITT) population: all randomized and treated 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 8 data were imputed by last observation carried forward \[LOCF\] method.
Outcome measures
| Measure |
Placebo + Atorvastatin 80 mg
n=29 Participants
Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 10 mg
n=29 Participants
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 80 mg
n=30 Participants
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 8 - On-treatment Analysis
|
-17.3 percent change
Standard Error 3.5
|
-66.2 percent change
Standard Error 3.5
|
-73.2 percent change
Standard Error 3.5
|
SECONDARY outcome
Timeframe: From baseline to Week 8 (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 + Atorvastatin 80 mg
n=29 Participants
Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 10 mg
n=29 Participants
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 80 mg
n=30 Participants
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
|---|---|---|---|
|
Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 8 - On-treatment Analysis
|
-0.56 mmol/L
Standard Error 0.11
|
-2.09 mmol/L
Standard Error 0.11
|
-2.31 mmol/L
Standard Error 0.11
|
SECONDARY outcome
Timeframe: From baseline to Week 8 (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 + Atorvastatin 80 mg
n=29 Participants
Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 10 mg
n=29 Participants
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 80 mg
n=30 Participants
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
|---|---|---|---|
|
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 8 - On-treatment Analysis
|
-21.5 mg/dL
Standard Error 4.2
|
-80.7 mg/dL
Standard Error 4.2
|
-89.3 mg/dL
Standard Error 4.1
|
SECONDARY outcome
Timeframe: Week 8 (LOCF)Population: mITT population.
Outcome measures
| Measure |
Placebo + Atorvastatin 80 mg
n=29 Participants
Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 10 mg
n=29 Participants
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 80 mg
n=30 Participants
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 8 - On-treatment Analysis
LDL-C < 100 mg/dL (2.59 mmol/L)
|
51.7 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 8 - On-treatment Analysis
LDL-C < 70 mg/dL (1.81 mmol/L)
|
17.2 percentage of participants
|
96.6 percentage of participants
|
90.0 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Week 8 (LOCF)Population: Participants of the mITT population with one baseline and at least one post-baseline on treatment value for lipid parameters analyzed. Here, n signifies number of participants analysed for each lipid parameter.
Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range).
Outcome measures
| Measure |
Placebo + Atorvastatin 80 mg
n=29 Participants
Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 10 mg
n=29 Participants
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 80 mg
n=30 Participants
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Total Cholesterol, Fasting Triglycerides, Non-high-Density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B (Apo-B) and Lipoprotein(a) at Week 8 - On-treatment Analysis
Total Cholesterol (n=29, 29, 30)
|
-16.6 percent change
Interval -25.1 to -3.2
|
-40.5 percent change
Interval -44.8 to -36.0
|
-47.2 percent change
Interval -51.5 to -37.8
|
|
Percent Change From Baseline in Total Cholesterol, Fasting Triglycerides, Non-high-Density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B (Apo-B) and Lipoprotein(a) at Week 8 - On-treatment Analysis
Fasting Triglycerides (n=29, 29, 30)
|
-11.9 percent change
Interval -30.4 to 14.3
|
-4.0 percent change
Interval -30.5 to 17.4
|
-24.7 percent change
Interval -40.3 to -4.4
|
|
Percent Change From Baseline in Total Cholesterol, Fasting Triglycerides, Non-high-Density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B (Apo-B) and Lipoprotein(a) at Week 8 - On-treatment Analysis
Non-HDL-C (n= 29, 29, 30)
|
-22.3 percent change
Interval -31.4 to -3.7
|
-58.3 percent change
Interval -63.9 to -50.2
|
-63.9 percent change
Interval -73.9 to -56.1
|
|
Percent Change From Baseline in Total Cholesterol, Fasting Triglycerides, Non-high-Density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B (Apo-B) and Lipoprotein(a) at Week 8 - On-treatment Analysis
Apo-B (n = 29, 28, 29)
|
-12.0 percent change
Interval -23.6 to -3.5
|
-54.4 percent change
Interval -60.2 to -48.3
|
-58.0 percent change
Interval -67.1 to -46.1
|
|
Percent Change From Baseline in Total Cholesterol, Fasting Triglycerides, Non-high-Density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B (Apo-B) and Lipoprotein(a) at Week 8 - On-treatment Analysis
Lipoprotein(a) (n= 29, 28, 29)
|
-2.7 percent change
Interval -19.5 to 16.7
|
-34.7 percent change
Interval -50.0 to -24.7
|
-31.0 percent change
Interval -50.0 to -15.4
|
SECONDARY outcome
Timeframe: From Baseline to Week 8 (LOCF)Population: Participants of the mITT population with one baseline and at least one post-baseline on treatment HDL-C value.
Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Outcome measures
| Measure |
Placebo + Atorvastatin 80 mg
n=29 Participants
Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 10 mg
n=29 Participants
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 80 mg
n=30 Participants
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 8 - On-treatment Analysis
|
-3.6 percent change
Standard Error 2.3
|
2.6 percent change
Standard Error 2.3
|
5.8 percent change
Standard Error 2.3
|
SECONDARY outcome
Timeframe: From Baseline to Week 8 (LOCF)Population: Participants of the mITT population with one baseline and at least one post-baseline on treatment value for lipid parameter analyzed
Adjusted LS means and standard errors were estimated using the same ANCOVA as for primary endpoint.
Outcome measures
| Measure |
Placebo + Atorvastatin 80 mg
n=29 Participants
Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 10 mg
n=28 Participants
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 80 mg
n=29 Participants
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
|---|---|---|---|
|
Absolute Change in the Ratio Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) From Baseline to Week 8 - On-treatment Analysis
|
-0.03 ratio
Interval -0.12 to 0.08
|
-0.34 ratio
Interval -0.44 to -0.27
|
-0.36 ratio
Interval -0.4 to -0.29
|
Adverse Events
Placebo + Atorvastatin 80mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Alirocumab + Atorvastatin 10 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Alirocumab + Atorvastatin 80 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + Atorvastatin 80mg
n=31 participants at risk
Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 10 mg
n=31 participants at risk
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 80 mg
n=30 participants at risk
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
0.00%
0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
3.3%
1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
Other adverse events
| Measure |
Placebo + Atorvastatin 80mg
n=31 participants at risk
Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 10 mg
n=31 participants at risk
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
|
Alirocumab + Atorvastatin 80 mg
n=30 participants at risk
Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
6.5%
2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
3.3%
1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
0.00%
0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
10.0%
3/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
|
Nervous system disorders
Headache
|
6.5%
2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
0.00%
0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
10.0%
3/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.7%
3/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
3.2%
1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
10.0%
3/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.1%
5/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
0.00%
0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
3.3%
1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
|
General disorders
Injection site pruritus
|
6.5%
2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
0.00%
0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
3.3%
1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
6.5%
2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 received at least one dose or partial dose of IMP.
|
6.7%
2/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal 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 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