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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522954-37-00 | EU Trial (CTIS) Number |
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This study is researching 2 different experimental drugs called REGN7508 and REGN9933. The study is focused on people who have Peripheral Artery Disease (PAD), which means that the blood vessels in their arms and legs have become too narrow. People with PAD have a higher risk of getting blood clots after procedures like Lower Extremity Revascularization (LER), a procedure to improve blood flow in the legs and feet.
The aim of this study is to see how well REGN7508 and REGN9933 prevent life-threatening blood clots in participants with PAD who have recently had LER. The effects of REGN7508 and REGN9933, individually, will also be compared to rivaroxaban and a placebo.
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
| |
| Cohort 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN7508 | Drug | Administered per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-first occurrence of a major thrombotic vascular event, consisting of Acute Limb Ischemia (ALI), major amputation (above the ankle) of vascular etiology, Myocardial Infarction (MI), ischemic stroke, or Cardiovascular (CV) death | Cohort 1 | Approximately up to 42 months |
| Time-to-first occurrence of International Society of Thrombosis and Hemostasis (ISTH) major or Clinically Relevant Non-major (CRNM) bleeding | Cohort 1 and 2 | Approximately up to 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total (first and subsequent) occurrences of major thrombotic vascular events, consisting of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke, or CV death | Cohort 1 and 2 | Approximately up to 42 months |
| Time-to-first occurrence of an expanded thrombotic vascular event, consisting of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke, CV death, unplanned index limb revascularization, or Venous Thromboembolism (VTE) |
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Key Inclusion Criteria:
Successful LER distal to the external iliac artery for ischemia due to atherosclerotic disease within 10 days prior to randomization as described in the protocol
At least 1 of the following enrichment factors for major thrombotic vascular events:
Key Exclusion Criteria:
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lake Martin Medical and Vascular Center | Recruiting | Alexander City | Alabama | 35010 | United States | |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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Cohort 1 of this study is double-blinded, and for Cohort 2 the participants, sponsor, and the investigators will be blinded to REGN7508 or REGN9933, but rivaroxaban will be administered as open-label.
| REGN9933 | Drug | Administered per the protocol |
|
|
| Placebo | Drug | Administered per the protocol |
|
| Rivaroxaban | Drug | Administered per the protocol |
|
Cohort 1 and 2 |
| Approximately up to 42 months |
| Time-to-first occurrence of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke or coronary death | Cohort 1 | Approximately up to 42 months |
| Time-to-first occurrence of vascular hospitalization for a coronary cerebrovascular, or peripheral event of thrombotic nature | Cohort 1 | Approximately up to 42 months |
| Time-to-first occurrence of ALI, major amputation of vascular etiology, MI, ischemic stroke, or all-cause mortality | Cohort 1 | Approximately up to 42 months |
| Time-to-first occurrence of unplanned index limb revascularization for ischemia | Cohort 1 | Approximately up to 42 months |
| Time-to-first occurrence of VTE | Cohort 1 | Approximately up to 42 months |
| Time-to-all-cause mortality | Cohort 1 | Approximately up to 42 months |
| Time-to-first occurrence of Major Adverse Limb Event (MALE) | Cohort 1 | Approximately up to 42 months |
| Time-to-first occurrence of Major Adverse Cardiovascular Event (MACE) | Cohort 1 | Approximately up to 42 months |
| Time-to-first occurrence of a major thrombotic vascular event or ISTH fatal/critical organ bleeding (net clinical benefit) | Cohort 1 | Approximately up to 42 months |
| Time-to-first occurrence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding | Cohort 1 and 2 | Approximately up to 42 months |
| Occurrence of Treatment-Emergent Adverse Event (TEAEs) | Cohort 1 and 2 | Approximately up to 45 months |
| Severity of TEAEs | Cohort 1 and 2 | Approximately up to 45 months |
| Occurrence of Anti-Drug Antibody (ADA) to REGN7508 over time | Cohort 1 and 2 | Approximately up to 45 months |
| Magnitude of ADA to REGN7508 over time | Cohort 1 and 2 | Approximately up to 45 months |
| Occurrence of ADA to REGN9933 over time | Cohort 1 and 2 | Approximately up to 45 months |
| Magnitude of ADA to REGN9933 over time | Cohort 1 and 2 | Approximately up to 45 months |
| Concentrations of REGN7508 over time | Cohort 1 and 2 | Approximately up to 45 months |
| Concentrations of REGN9933 over time | Cohort 1 and 2 | Approximately up to 45 months |
| Change from baseline in activated Partial Thromboplastin Time (aPTT) over time | Cohort 1 and 2 | Approximately up to week 9 |
| Change from baseline in Prothrombin Time (PT)/International Normalization Ratio (INR) over time | Cohort 1 and 2 | Approximately up to week 9 |
| Total (first and subsequent) occurrences of expanded thrombotic vascular events | Cohort 2 | Approximately up to 42 months |
| Time-to-first occurrence of a major thrombotic vascular event | Cohort 2 | Approximately up to 42 months |
| Total (first and subsequent) occurrences of ALI, major amputation (above the ankle) of vascular etiology, MI, all-cause stroke, or CV death | Cohort 2 | Approximately up to 42 months |
| Total (first and subsequent) occurrences of ALI, major amputation (above the ankle) of vascular etiology, MI, all-cause stroke, CV death, unplanned index limb revascularization, or VTE | Cohort 2 | Approximately up to 42 months |
| Axsendo Clinical Research, Integrated Medical Services |
| Recruiting |
| Avondale |
| Arizona |
| 85392 |
| United States |
| Applied Research Center of Arkansas | Recruiting | Little Rock | Arkansas | 72205 | United States |
| Nature Coast Clinical Research - Cardiology | Recruiting | Crystal River | Florida | 34429 | United States |
| Cardiovascular Solutions | Recruiting | Shreveport | Louisiana | 71103 | United States |
| Apex Research Foundation, LLC | Recruiting | Jackson | Tennessee | 38301 | United States |
| PharmaTex Research | Recruiting | Amarillo | Texas | 79106 | United States |
| Epic Medical Research | Recruiting | DeSoto | Texas | 75115 | United States |
| Epic Medical Research-Plano | Recruiting | Plano | Texas | 75093 | United States |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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