Trial Outcomes & Findings for Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) (NCT NCT01576484)

Last Updated: 2020-08-05

Results Overview

An AE was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. Treatment- emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on- treatment period (time from the first dose of study drug to the last dose of study drug plus 70 days). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

58 participants

Primary outcome timeframe

Baseline (Day 1 of current study) to end of study (Week 218)

Results posted on

2020-08-05

Participant Flow

The study was conducted at 15 sites in the United States and Canada between 28 Feb 2012 and 22 Dec 2016. A total of 59 participants were screened in the study.

Out of 59, 58 participants received alirocumab in this open-label extension study.

Participant milestones

Participant milestones
Measure	Placebo Participants in Parent Study Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
Overall Study STARTED	12	46
Overall Study COMPLETED	7	27
Overall Study NOT COMPLETED	5	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants in Parent Study Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
Overall Study Adverse Event	1	1
Overall Study Protocol Violation	0	2
Overall Study Sponsor Decision	2	8
Overall Study Withdrawal by Subject	0	3
Overall Study Other	2	5

Baseline Characteristics

Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Participants in Parent Study n=12 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=46 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Total n=58 Participants Total of all reporting groups
Age, Continuous	54.9 Years STANDARD_DEVIATION 9.7 • n=5 Participants	54.3 Years STANDARD_DEVIATION 9.4 • n=7 Participants	54.4 Years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	32 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	44 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	44 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1 of current study) to end of study (Week 218)

Population: Safety Analysis Set (SAF) included all participants who received at least 1 dose or part of a dose of alirocumab.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=12 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=46 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=58 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death Adverse Events	12 Participants	42 Participants	54 Participants
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death Serious Adverse Events	4 Participants	8 Participants	12 Participants
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death Adverse Events Leading to Death	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (current study) to Week 24

Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Percent change for serum LDL-C (Low-density lipoprotein cholesterol) from baseline to Week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=11 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=44 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=55 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Week 24	-73.15 percent change Standard Deviation 15.01	-63.40 percent change Standard Deviation 22.04	-65.35 percent change Standard Deviation 21.07

SECONDARY outcome

Timeframe: Baseline (current study) up to Week 12

Percent change for serum LDL-C (Low-density lipoprotein cholesterol) from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=12 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=44 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=56 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 12	-55.93 percent change Standard Deviation 29.53	-63.94 percent change Standard Deviation 23.35	-62.22 percent change Standard Deviation 24.73

SECONDARY outcome

Timeframe: Baseline(current study) up to Week 24

Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category.

Percent change for Apo B, Non-HDL-C and Total Cholesterol from baseline to Week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=12 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=46 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=58 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24 Apo B	-52.23 percent change Standard Deviation 20.30	-50.52 percent change Standard Deviation 18.18	-50.86 percent change Standard Deviation 18.43
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24 Non-HDL-C	-56.75 percent change Standard Deviation 21.80	-55.43 percent change Standard Deviation 20.97	-55.71 percent change Standard Deviation 20.95
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24 Total cholesterol	-42.72 percent change Standard Deviation 15.30	-41.47 percent change Standard Deviation 16.37	-41.74 percent change Standard Deviation 16.02

SECONDARY outcome

Timeframe: Baseline (current study) up to Week 12

Percent change for serum Apo B, Non-HDL-C, and Total Cholesterol from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=12 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=46 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=58 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12 Apo- B	-40.69 percent change Standard Deviation 30.46	-48.78 percent change Standard Deviation 20.24	-47.16 percent change Standard Deviation 22.56
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12 Non-HDL- C	-47.81 percent change Standard Deviation 32.92	-54.97 percent change Standard Deviation 22.85	-53.44 percent change Standard Deviation 25.18
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12 Total Cholesterol	-36.78 percent change Standard Deviation 24.88	-40.47 percent change Standard Deviation 16.93	-39.68 percent change Standard Deviation 18.72

SECONDARY outcome

Timeframe: Baseline (current study) up to Week 52

Percent change for serum LDL-C from baseline to Week 52 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=12 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=42 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=54 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 52	-54.57 percent change Standard Deviation 26.20	-55.67 percent change Standard Deviation 34.41	-55.43 percent change Standard Deviation 32.53

SECONDARY outcome

Timeframe: At Week 24

Percentage of participants reaching LDL-C goal (ie, LDL-C \<70 mg/dL (1.81 millimoles per liter \[mmol/L\]) in case of prior MI/stroke, or \<100 mg/dL \[2.59 mmol/L\] for participants without prior MI/stroke) at week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, were reported.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=11 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=44 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=55 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior Myocardial Infarction (MI)/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 24	100.00 Percentage of Participants	90.91 Percentage of Participants	92.73 Percentage of Participants

SECONDARY outcome

Timeframe: At Week 24

Percent change in serum lipoprotein a at week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=11 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=44 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=55 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Percent Change in Lipoprotein a (Lp[a]) at Week 24	-27.91 percent change Standard Deviation 23.62	-29.41 percent change Standard Deviation 25.01	-29.11 percent change Standard Deviation 24.53

SECONDARY outcome

Timeframe: At Week 24 and 12

Percent change for serum High Density Lipoprotein Cholesterol (HDL-C) in the current study at weeks 24 and week 12, during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=12 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=46 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=58 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Percent Change in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and Week 12 Week 24	2.61 percent change Standard Deviation 15.75	7.14 percent change Standard Deviation 16.04	6.17 percent change Standard Deviation 15.94
Percent Change in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and Week 12 Week 12	1.46 percent change Standard Deviation 14.08	10.43 percent change Standard Deviation 15.98	8.51 percent change Standard Deviation 15.91

SECONDARY outcome

Timeframe: At Week 12

Percent change for serum Lipoprotein a at Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=11 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=44 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=55 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Percent Change in Lipoprotein a at Week 12	-20.30 percent change Standard Deviation 24.10	-26.98 percent change Standard Deviation 22.71	-25.64 percent change Standard Deviation 22.92

SECONDARY outcome

Timeframe: At Week 24 and 12

Population: SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, "Number analyzed" signifies those participants who were evaluable for this outcome measure.

Percent change for serum TG at Week 24 and Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=12 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=46 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=58 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Percent Change in Triglycerides (TG) at Week 24 and Week 12 Week 24	0.19 percent change Standard Deviation 54.71	-2.01 percent change Standard Deviation 41.22	-1.54 percent change Standard Deviation 43.91
Percent Change in Triglycerides (TG) at Week 24 and Week 12 Week 12	-6.40 percent change Standard Deviation 46.11	0.52 percent change Standard Deviation 34.17	-0.96 percent change Standard Deviation 36.69

SECONDARY outcome

Timeframe: At Week 24 and Week 12

Percent change for serum Apo A-1 at Week 24 and Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=12 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=46 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=58 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Percent Change in Apolipoprotein A-1 (Apo A-1) at Week 24 and Week 12 Week 24	5.41 percent change Standard Deviation 11.96	4.78 percent change Standard Deviation 11.20	4.91 percent change Standard Deviation 11.24
Percent Change in Apolipoprotein A-1 (Apo A-1) at Week 24 and Week 12 Week 12	11.10 percent change Standard Deviation 11.43	8.64 percent change Standard Deviation 10.99	9.13 percent change Standard Deviation 11.02

SECONDARY outcome

Timeframe: Baseline (current study) to the End of Treatment (Week 208)

Percent change for serum LDL-C from baseline to Week 208 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=3 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=14 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=17 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to the End of Treatment	-52.20 percent change Standard Deviation 16.86	-58.46 percent change Standard Deviation 23.51	-57.36 percent change Standard Deviation 22.15

SECONDARY outcome

Timeframe: At Week 12, 52 and End of Treatment (Week 208)

Percentage of participants reaching LDL-C goal (ie, LDL-C \<70 mg/dL (1.81 millimoles per liter \[mmol/L\]) in case of prior MI/stroke, or \<100 mg/dL \[2.59 mmol/L\] for participants without prior MI/stroke) at week 12, 52 and end of treatment, during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, were reported.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=12 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=46 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=58 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment Week 12	83.33 percentage of participants	90.91 percentage of participants	89.29 percentage of participants
Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment Week 52	75.00 percentage of participants	83.33 percentage of participants	81.48 percentage of participants
Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment End of Treatment (Week 208)	100 percentage of participants	85.71 percentage of participants	88.24 percentage of participants

SECONDARY outcome

Timeframe: Baseline (current study) to Weeks 12, 24, 52, and End of Treatment (Week 208)

Absolute change was reported for serum LDL-C from baseline to weeks 12, 24, 52, and end of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=12 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=46 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=58 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment Week 12	-92.0 Milligram per Deciliter (mg/dL) Standard Deviation 54.3	-96.8 Milligram per Deciliter (mg/dL) Standard Deviation 44.7	-95.8 Milligram per Deciliter (mg/dL) Standard Deviation 46.4
Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment Week 24	-113.2 Milligram per Deciliter (mg/dL) Standard Deviation 24.9	-95.3 Milligram per Deciliter (mg/dL) Standard Deviation 40.0	-98.9 Milligram per Deciliter (mg/dL) Standard Deviation 37.9
Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment Week 52	-87.0 Milligram per Deciliter (mg/dL) Standard Deviation 44.5	-83.8 Milligram per Deciliter (mg/dL) Standard Deviation 58.6	-84.5 Milligram per Deciliter (mg/dL) Standard Deviation 55.4
Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment Week 208	-80.3 Milligram per Deciliter (mg/dL) Standard Deviation 38.7	-78.1 Milligram per Deciliter (mg/dL) Standard Deviation 33.6	-78.5 Milligram per Deciliter (mg/dL) Standard Deviation 33.2

SECONDARY outcome

Timeframe: Baseline (current study) up to Weeks 52 and End of Treatment (Week 208)

Percent change was reported for serum (Apo B), non-HDL-C, total-C, Lp(a), HDL-C, TG, and Apo A-1 from baseline to weeks 52 and end of treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=12 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=46 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=58 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment Apo B : Week 52	-43.04 percent change Standard Deviation 25.60	-45.17 percent change Standard Deviation 28.51	-44.73 percent change Standard Deviation 27.71
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment Apo B : Week 208	-45.02 percent change Standard Deviation 17.58	-48.07 percent change Standard Deviation 18.61	-47.53 percent change Standard Deviation 17.93
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment Non- HDL-C: Week 52	-47.10 percent change Standard Deviation 27.26	-48.60 percent change Standard Deviation 31.71	-48.27 percent change Standard Deviation 30.54
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment Non- HDL-C: Week 208	-43.29 percent change Standard Deviation 17.98	-50.34 percent change Standard Deviation 21.40	-49.10 percent change Standard Deviation 20.50
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment Total -C : Week 52	-35.09 percent change Standard Deviation 19.16	-36.41 percent change Standard Deviation 24.89	-36.11 percent change Standard Deviation 23.57
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment Total -C : Week 208	-35.33 percent change Standard Deviation 11.92	-37.01 percent change Standard Deviation 16.59	-36.72 percent change Standard Deviation 15.55
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment Lp-(a): Week 52	-24.77 percent change Standard Deviation 25.14	-22.91 percent change Standard Deviation 30.33	-23.30 percent change Standard Deviation 29.11
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment Lp-(a): Week 208	-23.92 percent change Standard Deviation 39.92	-31.29 percent change Standard Deviation 30.20	-29.99 percent change Standard Deviation 30.80
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment HDL-C: Week 52	5.40 percent change Standard Deviation 17.64	7.74 percent change Standard Deviation 14.21	7.22 percent change Standard Deviation 14.89
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment HDL-C: Week 208	-9.83 percent change Standard Deviation 12.49	4.94 percent change Standard Deviation 11.25	2.34 percent change Standard Deviation 12.49
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment TG : Week 52	-6.04 percent change Standard Deviation 41.12	-3.84 percent change Standard Deviation 40.25	-4.33 percent change Standard Deviation 40.07
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment TG : Week 208	16.69 percent change Standard Deviation 28.93	-5.28 percent change Standard Deviation 23.05	-1.40 percent change Standard Deviation 24.71
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment Apo A-1 : Week 52	6.76 percent change Standard Deviation 10.82	3.90 percent change Standard Deviation 10.80	4.49 percent change Standard Deviation 10.76
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment Apo A-1 : Week 208	-1.46 percent change Standard Deviation 4.48	9.53 percent change Standard Deviation 7.45	7.59 percent change Standard Deviation 8.14

SECONDARY outcome

Timeframe: Baseline (current study) to Weeks 12, 24, 52, and End of Treatment (Week 208)

Change in ratio in Apolipoprotein (Apo) B/Apo A-1 from baseline in current Study to week 12, 24, 52, and end of treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=12 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=44 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=56 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. Change at Week 12	-0.397 Ratio Standard Deviation 0.234	-0.456 Ratio Standard Deviation 0.230	-0.444 Ratio Standard Deviation 0.230
Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. Change at Week 24	-0.450 Ratio Standard Deviation 0.162	-0.460 Ratio Standard Deviation 0.211	-0.458 Ratio Standard Deviation 0.201
Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. Change at Week 52	-0.385 Ratio Standard Deviation 0.210	-0.416 Ratio Standard Deviation 0.295	-0.410 Ratio Standard Deviation 0.278
Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment. Change at Week 208	-0.330 Ratio Standard Deviation 0.165	-0.402 Ratio Standard Deviation 0.164	-0.389 Ratio Standard Deviation 0.161

SECONDARY outcome

Timeframe: At Week 12, 24, 52, and End of Treatment (Week 208)

Percentage of participants was calculated with Apo B \<80 mg/dL (0.8 mmol/L) at week 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=12 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=46 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=58 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment Week 12	66.67 percentage of participants	79.55 percentage of participants	76.79 percentage of participants
Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment Week 24	91.67 percentage of participants	81.82 percentage of participants	83.93 percentage of participants
Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment Week 52	66.67 percentage of participants	73.81 percentage of participants	72.22 percentage of participants
Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment Week 208	100.00 percentage of participants	85.71 percentage of participants	88.24 percentage of participants

SECONDARY outcome

Timeframe: At Week 12, 24, 52, and End of Treatment (Week 208)

Percentage of participants was calculated with non-HDL-C \<100 mg/dL (2.59 mmol/L) at Weeks 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=12 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=46 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=58 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment Week 12	58.33 percentage of participants	75.00 percentage of participants	71.43 percentage of participants
Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment Week 24	91.67 percentage of participants	81.82 percentage of participants	83.93 percentage of participants
Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment Week 52	58.33 percentage of participants	73.81 percentage of participants	70.37 percentage of participants
Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment Week 208	66.67 percentage of participants	78.57 percentage of participants	76.47 percentage of participants

SECONDARY outcome

Timeframe: At Week 12, 24, 52, and End of Treatment (Week 208)

Percentage of Participants was calculated with LDL-C \<70 mg/dL (1.81 mmol/L) and/or ≥ 50% Reduction in LDL-C (if LDL-C \>70 mg/dL \[1.81 mmol/L\]) at Weeks 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Outcome measures

Outcome measures
Measure	Placebo Participants in Parent Study n=12 Participants Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=46 Participants Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	All Participants n=58 Participants All participants who received placebo or alirocumab in the parent study (NCT01576484).
Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment Week 12	66.67 percentage of participants	86.36 percentage of participants	82.14 percentage of participants
Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment Week 24	100.00 percentage of participants	81.82 percentage of participants	85.45 percentage of participants
Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment Week 52	75.00 percentage of participants	73.81 percentage of participants	74.07 percentage of participants
Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment Week 208	66.67 percentage of participants	85.71 percentage of participants	82.35 percentage of participants

Adverse Events

Placebo Participants in Parent Study

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Participants Previously Exposed to Alirocumab in Parent Study

Serious events: 8 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Participants in Parent Study n=12 participants at risk Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Participants Previously Exposed to Alirocumab in Parent Study n=46 participants at risk Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
Cardiac disorders Angina unstable	0.00% 0/12 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.	2.2% 1/46 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.
Cardiac disorders Aortic valve stenosis	8.3% 1/12 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.	0.00% 0/46 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.
Cardiac disorders Atrial fibrillation	0.00% 0/12 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.	2.2% 1/46 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.
Cardiac disorders Atrial flutter	0.00% 0/12 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.	2.2% 1/46 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.
Cardiac disorders Coronary artery disease	0.00% 0/12 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.	2.2% 1/46 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/12 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.	2.2% 1/46 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/12 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.	2.2% 1/46 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.
Gastrointestinal disorders Intestinal obstruction	8.3% 1/12 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.	0.00% 0/46 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.
Infections and infestations Gastrointestinal viral infection	0.00% 0/12 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.	2.2% 1/46 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/12 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.	2.2% 1/46 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/12 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.	2.2% 1/46 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.
Nervous system disorders Amnesia	8.3% 1/12 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.	0.00% 0/46 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.
Nervous system disorders Carotid artery disease	8.3% 1/12 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.	0.00% 0/46 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.
Psychiatric disorders Neuropsychiatric symptoms	8.3% 1/12 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.	0.00% 0/46 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events, which are defined as those that are not present at screening, or represent the exacerbation of a pre-existing condition during the treatment period.

Other adverse events

Additional Information

Clinical Trial Administrator

Regeneron Pharmaceuticals, Inc.

Phone: 844-734-6643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER