Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003170-13 | EudraCT Number |
Not provided
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The primary objectives of the study are:
The secondary objectives of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| evinacumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| evinacumab | Drug | Intravenous (IV) administration |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to Week 216 | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Up to 216 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Up to 120 weeks |
| Absolute Change in LDL-C Over Time |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Los Angeles | California | 90048 | United States | ||
| Clinical Trial Site |
Not provided
| Label | URL |
|---|---|
| A Plain Language Summary is available on TrialSummaries.com | View source |
Not provided
A total of 118 participants were planned to be enrolled. 116 participants were enrolled & treated. Reasons for screen fail were: 1 participant was unwilling to use protocol defined contraception, and 1 participant had a Low-density lipoprotein cholesterol (LDL-C) level less than the lower limit required for inclusion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Evinacumab | Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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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 | Oct 17, 2022 | Mar 13, 2024 |
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The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. |
| Up to 120 weeks |
| Percent Change in Apolipoprotein B (Apo B) Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Up to 120 weeks |
| Absolute Change in Apo B Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Up to 120 weeks |
| Percent Change in Non-High-Density Lipoprotein Cholesterol (HDL-C) Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Up to 120 weeks |
| Absolute Change in Non-HDL-C Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Up to 120 weeks |
| Percent Change in Total Cholesterol (TC) Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Up to 120 weeks |
| Absolute Change in TC Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Up to 120 weeks |
| Percent Change in Triglycerides (TGs) Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Up to 120 weeks |
| Absolute Change in TGs Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Up to 120 weeks |
| Boca Raton |
| Florida |
| 33434 |
| United States |
| Clinical Trial Site | Boston | Massachusetts | 02114 | United States |
| Clinical Trial Site | New York | New York | 10029 | United States |
| Clinical Trial Site | Cincinnati | Ohio | 45227 | United States |
| Clinical Trial Site | Portland | Oregon | 97239 | United States |
| Clinical Trial Site | Philadelphia | Pennsylvania | 19104 | United States |
| Clinical Trial Site | Dallas | Texas | 75226 | United States |
| Clinical Trial Site | Dallas | Texas | 75390 | United States |
| Clinical Trial Site | Camperdown | New South Wales | 2050 | Australia |
| Clinical Trial Site | Perth | Western Australia | 6000 | Australia |
| Regeneron Study Site | Vienna | State of Vienna | 1090 | Austria |
| Regeneron Study Site | Innsbruck | 6020 | Austria |
| Clinical Trial Site | Chicoutimi | Quebec | G7H 7K9 | Canada |
| Clinical Trial Site | Québec | G1V 4W2 | Canada |
| Regeneron Study Site | Prague | Kateřinská | 121 08 | Czechia |
| Clinical Trial Site | Paris | Cedex 13 | 75651 | France |
| Clinical Trial Site | Marseille | Cedex 5 | 13385 | France |
| Clinical Trial Site | Dijon | Cedex | 21079 | France |
| Regeneron Study Site | Kallithea | Athens | 17674 | Greece |
| Clinical Trial Site | Ioannina | 45500 | Greece |
| Clinical Trial Site | Naples | Campania | 80131 | Italy |
| Clinical Trial Site | Roma | Rome | 161 | Italy |
| Clinical Trial Site | Ōbu | Aichi-ken | 474-8710 | Japan |
| Regeneron Study Site | Kurume | Fukuoka | 830-8522 | Japan |
| Regeneron Study Site | Nishinomiya | Hyōgo | 662-0918 | Japan |
| Regeneron Study Site | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Regeneron Study Site | Kita-ku | Osaka | 530-0001 | Japan |
| Regeneron Study Site | Suita | Osaka | 564-8565 | Japan |
| Regeneron Study Site | Suita | Osaka | 565-0871 | Japan |
| Clinical Trial Site | Amsterdam | 1105 AZ | Netherlands |
| Regeneron Study Site | Johannesburg | Gauteng | 2000 | South Africa |
| Regeneron Study Site | Cape Town | Western Cape | 7925 | South Africa |
| Clinical Trial Site | Ivano-Frankivsk | 76075 | Ukraine |
| Clinical Trial Site #1 | Kharkiv | 61039 | Ukraine |
| Clinical Trial Site #2 | Kharkiv | 61176 | Ukraine |
| Clinical Trial Site | Kyiv | 02660 | Ukraine |
| Rgeneron Study Site | Kyiv | 3680 | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Total Evinacumab | Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | 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 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to Week 216 | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Posted | Number | Number of participants | Up to 216 weeks |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Here 'n' = number of evaluable participants at the specified timepoint | Posted | Mean | Standard Deviation | Percentage of change | Up to 120 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Absolute Change in LDL-C Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Here 'n' = number of evaluable participants at the specified timepoint | Posted | Mean | Standard Deviation | mg/dL | Up to 120 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Apolipoprotein B (Apo B) Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Here 'n' = number of evaluable participants at the specified timepoint | Posted | Mean | Standard Deviation | Percentage of change | Up to 120 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Absolute Change in Apo B Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Here 'n' = number of evaluable participants at the specified timepoint | Posted | Mean | Standard Deviation | mg/dL | Up to 120 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Non-High-Density Lipoprotein Cholesterol (HDL-C) Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Here 'n' = number of evaluable participants at the specified timepoint | Posted | Mean | Standard Deviation | Percentage of change | Up to 120 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Absolute Change in Non-HDL-C Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Here 'n' = number of evaluable participants at the specified timepoint | Posted | Mean | Standard Deviation | mg/dL | Up to 120 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Total Cholesterol (TC) Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Here 'n' = number of evaluable participants at the specified timepoint | Posted | Mean | Standard Deviation | Percentage of change | Up to 120 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Absolute Change in TC Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Here 'n' = number of evaluable participants at the specified timepoint | Posted | Mean | Standard Deviation | mg/dL | Up to 120 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Triglycerides (TGs) Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Here 'n' = number of evaluable participants at the specified timepoint | Posted | Mean | Standard Deviation | Percentage of change | Up to 120 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Absolute Change in TGs Over Time | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | Here 'n' = number of evaluable participants at the specified timepoint | Posted | Mean | Standard Deviation | mg/dL | Up to 120 weeks |
|
|
From signing of Informed Consent to week 216
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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 | Overall | Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. | 2 | 116 | 27 | 116 | 79 | 116 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Aortic valve disease | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cardiac valve disease | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Supravalvular aortic stenosis | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Spinal epidural haematoma | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Renal infarct | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA (26.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | 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_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2019 | Mar 13, 2024 | 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
| Unknown or Not Reported |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Not Reported |
|
| Other |
|
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| Title | Denominators | Categories | ||||
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| Week 24 |
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| Week 48 |
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| Week 72 |
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| Week 96 |
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| Week 120 |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Week 24 |
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| Week 48 |
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| Week 72 |
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| Week 96 |
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| Week 120 |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Week 24 |
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| Week 48 |
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| Week 72 |
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| Week 96 |
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| Week 120 |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 8 |
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| Week 24 |
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| Week 48 |
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| Week 72 |
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| Week 96 |
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| Week 120 |
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