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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001931-30 | EudraCT Number |
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The primary objective for Part A of the study is to assess the pharmacokinetics (PK) of evinacumab in pediatric patients with homozygous familial hypercholesterolemia (HoFH).
The primary objective for Part B of the study is to demonstrate a reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab in pediatric (5 to 11 years of age) patients with HoFH.
The secondary objective for Part A of the study is to evaluate the safety and tolerability of evinacumab administered intravenous (IV) in pediatric patients with HoFH.
The secondary objectives for Part B of the study are:
Part A is Phase 1b Part B is Phase 3
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evinacumab | Experimental | Part A: Single intravenous (IV) dose Part B: IV dose every 4 weeks (Q4W) until week 20 Part C: IV dose Q4W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evinacumab | Drug | Part A: Single IV dose Part B & C: IV dose Q4W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Maximum Observed Serum Concentration (Cmax) of Evinacumab | Cmax was obtained directly from the plasma concentration versus time curve. | At day 12 |
| Part A: Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast) of Evinacumab | AUClast was defined as area under the serum concentration time-curve from zero to the last measured concentration. | Up to Week 12 |
| Part A: Terminal Half-Life (t1/2) of Evinacumab | T1/2 was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination. | Up to week 12 |
| Part B: Percent Change in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 24 | Percent change was calculated as 100 multiplied by (calculated LDL-C value at Week 24 minus calculated LDL-C value at baseline) divided by calculated LDL-C value at baseline. | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. 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. TEAE was defined as AE starting/worsening after first intake of study drug. TEAE included participants with both serious and non-serious AEs. 1 participant experienced an AE during part B that was recorded after Part B database lock. This was not reflected in the reported endpoint number of participants of 10. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Research Site | Wilmington | Delaware | 19803 | United States | ||
| Regeneron Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37860863 | Derived | Wiegman A, Greber-Platzer S, Ali S, Reijman MD, Brinton EA, Charng MJ, Srinivasan S, Baker-Smith C, Baum S, Brothers JA, Hartz J, Moriarty PM, Mendell J, Bihorel S, Banerjee P, George RT, Hirshberg B, Pordy R. Evinacumab for Pediatric Patients With Homozygous Familial Hypercholesterolemia. Circulation. 2024 Jan 30;149(5):343-353. doi: 10.1161/CIRCULATIONAHA.123.065529. Epub 2023 Oct 20. |
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All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
A total of 23 participants were screened to Part A and Part B. 6 participants were enrolled in Part A, 14 participants in Part B. 3 participants were considered screen failures. 2 withdrew consent, 1 due to Other. Participants who enrolled in Part A of study were not eligible to participate in Part B. All 20 participants completed part C.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Evinacumab 15mg/Kg IV | In Part A, Participants received single IV infusion of evinacumab at a dose of 15 mg/kg on Day 1. |
| FG001 | Part B: Evinacumab 15mg/Kg IV Q4W | In Part B, Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from Day 1 up to Week 24. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Part A and B |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2022 | May 13, 2024 |
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| Part A: up to Week 24; Part B: up to Week 48 |
| Part B: Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 24 | Percent change in Apo B from baseline to Week 24 was reported. | Baseline to Week 24 |
| Part B: Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 24 | Percent change in Non-HDL-C from baseline to Week 24 was reported. | Baseline to Week 24 |
| Part B: Percent Change in Total Cholesterol (TC) From Baseline to Week 24 | Percent change in TC from baseline to Week 24 was reported. | Baseline to Week 24 |
| Part B: Percentage of Participants With ≥50 Percent (%) Reduction in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 | Percentage of participants who achieved reduction in calculated LDL-C ≥ 50% at Week 24 was reported. | Week 24 |
| Part B: Percent Change in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 24 in Participants Who Have Negative/Negative and Null/Null Mutations | Participants with HoFH was classified based on the phenotype of the Low-density lipoprotein receptor (LDLR) mutation(s), ranging from defective mutations (where the LDLR retains some LDL-binding functionality) to null or negative mutations where no functioning LDLR was expressed. Participants who have LDLR activity <15% are considered null and participants whose LDLR activity was impaired but >15% are LDLR defective. Percent change in calculated LDL-C from baseline to Week 24 in participants who have negative/negative and null/null mutations was reported. | Baseline to Week 24 |
| Part B: Percent Change in Lipoprotein A (Lp[a]) From Baseline to Week 24 | Percent change in Lp(a) from baseline to Week 24 was reported. | Baseline to Week 24 |
| Part B: Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Week 24 | Absolute change in LDL-C from baseline at Week 24 was reported | Baseline, Week 24 |
| Part B: Serum Concentration of Total Evinacumab | Serum concentration of total evinacumab was reported. Pre-dose samples at week 0 were assayed and the reported value is based on actual measurement. | Pre-dose at Weeks 0, 4, 8, 12; End of infusion at Weeks 0.006, 4.006, 8.006, 12.006 and 24 |
| Part B: Maximum Serum Concentration at Steady State (Cmax,ss) of Evinacumab | Maximum serum concentration (Cmax,ss) steady state following drug administration. | Post-dose up to day 169 |
| Part B: Area Under the Serum Concentration-time Curve at Steady State (AUCtau.ss) of Evinacumab | AUCtau.ss was defined as area under the serum concentration-time curve at steady state of evinacumab | Post-dose up to day 169 |
| Part B: Minimum Serum Concentration at Steady State (Ctrough.ss) of Evinacumab | Ctrough.ss was defined as minimum serum concentration at steady state of evinacumab | Post-dose up to day 169 |
| Part B: Percent Change in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 24 in Participants Who Have by Null/Null vs. Non-null/Null and Negative/Negative vs.Non-negative/Negative Mutations | Baseline to Week 24 |
| Boca Raton |
| Florida |
| 33434 |
| United States |
| Regeneron Research Site | Kansas City | Kansas | 66190 | United States |
| Regeneron Research Center | Boston | Massachusetts | 02115 | United States |
| Regeneron Research Center | Philadelphia | Pennsylvania | 19106 | United States |
| Regeneron Research Center | Salt Lake City | Utah | 84108 | United States |
| Regeneron Research Center | Westmead | New South Wales | 2145 | Australia |
| Regeneron Research Site | Vienna | 1090 | Austria |
| Regeneron Research Site | Amsterdam | 1105 AZ | Netherlands |
| Regeneron Research Center | Taipei | 11217 | Taiwan |
| Regeneron Research Site | Kyiv | 04209 | Ukraine |
| FG002 | Part A to C | All participants who completed Part A received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from Day 1 up to Week 48 in Part C. |
| FG003 | Part B to C | All participants who completed Part B received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from Day 1 up to Week 48 in Part C. |
| COMPLETED |
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| NOT COMPLETED |
|
| Part C (Extension Period) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Evinacumab 15mg/Kg IV | Participants received single intravenous (IV) infusion of evinacumab at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 in Part A. |
| BG001 | Part B: Evinacumab 15mg/Kg IV Q4W | Participants received IV infusion of evinacumab at a dose of 15 mg/kg every four weeks (Q4W) from Day 1 up to Week 24 in Part B. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part A: Maximum Observed Serum Concentration (Cmax) of Evinacumab | Cmax was obtained directly from the plasma concentration versus time curve. | Pharmacokinetic (PK) Analysis Set included all participants who received any study drug and who had at least 1 non-missing result for concentration of evinacumab following the first dose of study drug. | Posted | Mean | Standard Deviation | Milligrams per Liter (mg/L) | At day 12 |
|
|
| |||||||||||||||||||||||||
| Primary | Part A: Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast) of Evinacumab | AUClast was defined as area under the serum concentration time-curve from zero to the last measured concentration. | PK Analysis Set included all participants who received any study drug and who had at least 1 non-missing result for concentration of evinacumab following the first dose of study drug. | Posted | Mean | Standard Deviation | Days*Milligrams per Liter (day*mg/L) | Up to Week 12 |
|
| ||||||||||||||||||||||||||
| Primary | Part A: Terminal Half-Life (t1/2) of Evinacumab | T1/2 was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination. | PK Analysis Set included all participants who received any study drug and who had at least 1 non-missing result for concentration of evinacumab following the first dose of study drug. | Posted | Median | Full Range | Days | Up to week 12 |
|
| ||||||||||||||||||||||||||
| Primary | Part B: Percent Change in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 24 | Percent change was calculated as 100 multiplied by (calculated LDL-C value at Week 24 minus calculated LDL-C value at baseline) divided by calculated LDL-C value at baseline. | The intent-to-treat (ITT) population included all participants who received at least 1 dose or part of a dose of study drug in Part B. | Posted | Mean | 95% Confidence Interval | Percentage of Change | Baseline to Week 24 |
|
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| Secondary | Part A and Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. 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. TEAE was defined as AE starting/worsening after first intake of study drug. TEAE included participants with both serious and non-serious AEs. 1 participant experienced an AE during part B that was recorded after Part B database lock. This was not reflected in the reported endpoint number of participants of 10. | The safety analysis set (SAF) includes all patients in Part A or Part B who received at least 1 dose or part of a dose of study drug in the respective study treatment period. | Posted | Count of Participants | Participants | Part A: up to Week 24; Part B: up to Week 48 |
| ||||||||||||||||||||||||||||
| Secondary | Part B: Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 24 | Percent change in Apo B from baseline to Week 24 was reported. | ITT population included all participants who received at least 1 dose or part of a dose of study drug in Part B. | Posted | Mean | 95% Confidence Interval | Percentage of Change | Baseline to Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Part B: Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 24 | Percent change in Non-HDL-C from baseline to Week 24 was reported. | ITT population included all participants who received at least 1 dose or part of a dose of study drug in Part B. | Posted | Mean | 95% Confidence Interval | Percentage of Change | Baseline to Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Part B: Percent Change in Total Cholesterol (TC) From Baseline to Week 24 | Percent change in TC from baseline to Week 24 was reported. | ITT population included all participants who received at least 1 dose or part of a dose of study drug in Part B. | Posted | Mean | 95% Confidence Interval | Percentage of Change | Baseline to Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Part B: Percentage of Participants With ≥50 Percent (%) Reduction in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 | Percentage of participants who achieved reduction in calculated LDL-C ≥ 50% at Week 24 was reported. | ITT population included all participants who received at least 1 dose or part of a dose of study drug in Part B. | Posted | Number | Percentage of Participants | Week 24 |
|
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| Secondary | Part B: Percent Change in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 24 in Participants Who Have Negative/Negative and Null/Null Mutations | Participants with HoFH was classified based on the phenotype of the Low-density lipoprotein receptor (LDLR) mutation(s), ranging from defective mutations (where the LDLR retains some LDL-binding functionality) to null or negative mutations where no functioning LDLR was expressed. Participants who have LDLR activity <15% are considered null and participants whose LDLR activity was impaired but >15% are LDLR defective. Percent change in calculated LDL-C from baseline to Week 24 in participants who have negative/negative and null/null mutations was reported. | ITT population included all participants who received at least 1 dose or part of a dose of study drug in Part B. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified category. | Posted | Mean | Standard Error | Percentage of Change | Baseline to Week 24 |
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| Secondary | Part B: Percent Change in Lipoprotein A (Lp[a]) From Baseline to Week 24 | Percent change in Lp(a) from baseline to Week 24 was reported. | ITT population included all participants who received at least 1 dose or part of a dose of study drug in Part B. | Posted | Mean | 95% Confidence Interval | Percentage of Change | Baseline to Week 24 |
|
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| Secondary | Part B: Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Week 24 | Absolute change in LDL-C from baseline at Week 24 was reported | ITT population included all participants who received at least 1 dose or part of a dose of study drug in Part B. | Posted | Mean | Standard Error | Milligrams per Deciliter (mg/dL) | Baseline, Week 24 |
|
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| Secondary | Part B: Serum Concentration of Total Evinacumab | Serum concentration of total evinacumab was reported. Pre-dose samples at week 0 were assayed and the reported value is based on actual measurement. | PK Analysis Set included all participants who received any study drug and who had at least 1 non-missing result for concentration of evinacumab following the first dose of study drug. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | Milligrams per Liter (mg/L) | Pre-dose at Weeks 0, 4, 8, 12; End of infusion at Weeks 0.006, 4.006, 8.006, 12.006 and 24 |
|
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| Secondary | Part B: Maximum Serum Concentration at Steady State (Cmax,ss) of Evinacumab | Maximum serum concentration (Cmax,ss) steady state following drug administration. | PK Analysis Set included all participants who received any study drug and who had at least 1 non-missing result for concentration of evinacumab following the first dose of study drug. | Posted | Mean | Standard Deviation | Milligrams per Liter (mg/L) | Post-dose up to day 169 |
|
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| Secondary | Part B: Area Under the Serum Concentration-time Curve at Steady State (AUCtau.ss) of Evinacumab | AUCtau.ss was defined as area under the serum concentration-time curve at steady state of evinacumab | PK Analysis Set included all participants who received any study drug and who had at least 1 non-missing result for concentration of evinacumab following the first dose of study drug. | Posted | Mean | Standard Deviation | Day*Milligrams per Liter (Day*mg/L) | Post-dose up to day 169 |
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| Secondary | Part B: Minimum Serum Concentration at Steady State (Ctrough.ss) of Evinacumab | Ctrough.ss was defined as minimum serum concentration at steady state of evinacumab | PK Analysis Set included all participants who received any study drug and who had at least 1 non-missing result for concentration of evinacumab following the first dose of study drug. | Posted | Mean | Standard Deviation | Milligrams per Liter (mg/L) | Post-dose up to day 169 |
|
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| Secondary | Part B: Percent Change in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 24 in Participants Who Have by Null/Null vs. Non-null/Null and Negative/Negative vs.Non-negative/Negative Mutations | ITT population included all participants who received at least 1 dose or part of a dose of study drug in Part B. | Posted | Mean | Standard Error | Percentage of Change | Baseline to Week 24 |
|
|
From first dose up to week 96 (24 weeks in Part A/B + 48 weeks of treatment in Part C + 24 weeks of follow-up)
Part A - up to week 24
Part B - up to Week 48 or up to the day before the first dose in Part C for participants entering Part C; 1 participant experienced an AE during part B that was recorded after Part B database lock.
Part C - up to a 48-week treatment period and 24-week follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A Evinacumab 15mg | Participants received single intravenous (IV) infusion of evinacumab at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 in Part A. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG001 | Part B Evinacumab 15mg | Participants received IV infusion of evinacumab at a dose of 15 mg/kg every four weeks (Q4W) from Day 1 up to Week 24 in Part B. | 0 | 14 | 1 | 14 | 11 | 14 |
| EG002 | Part A-C Evinacumab 15mg | All participants who completed Part A received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from Day 1 up to Week 48 in Part C. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG003 | Part B-C Evinacumab 15mg | All participants who completed Part B received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from Day 1 up to Week 48 in Part C. | 0 | 14 | 1 | 14 | 11 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tonsillitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Vitamin D decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Poikilocytosis | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Papilloedema | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Retinal thickening | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Apheresis related complication | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA (26.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Infusion site swelling | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Lipoprotein (a) increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Burn oral cavity | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Regeneron Pharmaceuticals, Inc | 844-734-6643 | clinicaltrials@regeneron.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 18, 2021 | Apr 19, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000090542 | Homozygous Familial Hypercholesterolemia |
| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000621590 | evinacumab |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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