A Phase 3 interventional study of REGN7508 and REGN9933 in Peripheral Artery Disease (PAD), sponsored by Regeneron Pharmaceuticals. Recruiting at 32 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment
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:
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 7,050 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
At least 1 of the following enrichment factors for major thrombotic vascular events:
Key Exclusion Criteria:
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: REGN7508 · Drug: REGN9933 · Drug: Placebo
Drug: REGN7508 · Drug: REGN9933 · Drug: Rivaroxaban
Administered per the protocol
Also known as: cenvacibart
Administered per the protocol
Also known as: amrecibart
Administered per the protocol
Administered per the protocol
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
Time frame: 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
Time frame: Approximately up to 42 months
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
Time frame: 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)
Cohort 1 and 2
Time frame: 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
Time frame: Approximately up to 42 months
Time-to-first occurrence of vascular hospitalization for a coronary cerebrovascular, or peripheral event of thrombotic nature
Cohort 1
Time frame: 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
Time frame: Approximately up to 42 months
Time-to-first occurrence of unplanned index limb revascularization for ischemia
Cohort 1
Time frame: Approximately up to 42 months
Time-to-first occurrence of VTE
Cohort 1
Time frame: Approximately up to 42 months
Time-to-all-cause mortality
Cohort 1
Time frame: Approximately up to 42 months
Time-to-first occurrence of Major Adverse Limb Event (MALE)
Cohort 1
Time frame: Approximately up to 42 months
Time-to-first occurrence of Major Adverse Cardiovascular Event (MACE)
Cohort 1
Time frame: 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
Time frame: Approximately up to 42 months
Time-to-first occurrence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding
Cohort 1 and 2
Time frame: Approximately up to 42 months
Occurrence of Treatment-Emergent Adverse Event (TEAEs)
Cohort 1 and 2
Time frame: Approximately up to 45 months
Severity of TEAEs
Cohort 1 and 2
Time frame: Approximately up to 45 months
Occurrence of Anti-Drug Antibody (ADA) to REGN7508 over time
Cohort 1 and 2
Time frame: Approximately up to 45 months
Magnitude of ADA to REGN7508 over time
Cohort 1 and 2
Time frame: Approximately up to 45 months
Occurrence of ADA to REGN9933 over time
Cohort 1 and 2
Time frame: Approximately up to 45 months
Magnitude of ADA to REGN9933 over time
Cohort 1 and 2
Time frame: Approximately up to 45 months
Concentrations of REGN7508 over time
Cohort 1 and 2
Time frame: Approximately up to 45 months
Concentrations of REGN9933 over time
Cohort 1 and 2
Time frame: Approximately up to 45 months
Change from baseline in activated Partial Thromboplastin Time (aPTT) over time
Cohort 1 and 2
Time frame: Approximately up to week 9
Change from baseline in Prothrombin Time (PT)/International Normalization Ratio (INR) over time
Cohort 1 and 2
Time frame: Approximately up to week 9
Total (first and subsequent) occurrences of expanded thrombotic vascular events
Cohort 2
Time frame: Approximately up to 42 months
Time-to-first occurrence of a major thrombotic vascular event
Cohort 2
Time frame: 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
Time frame: 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
Time frame: Approximately up to 42 months
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 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 or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) the legal authority to share the data, and ensured the ability to protect participant privacy
Access criteria: 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
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Aug 2029, 37 months after the start.
Of 26 phase 3 interventional studies under Peripheral Arterial Disease, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 58. This study's planned 37 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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