REGN7508 and REGN9933 for Peripheral Artery Disease
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Recruiting
Phase 3Interventional Study
Peripheral Artery Disease (PAD)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
7,050 (estimated)
Sponsor
Regeneron Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for adults with Peripheral Artery Disease who have had a recent procedure to improve blood flow in their legs. Participants will try either of two experimental drugs or a standard treatment to see how well they prevent dangerous blood clots.
Are You a Good Fit for This Trial?
You may be able to join if
I have had a successful procedure to improve blood flow in my legs within the last 10 days.
I am 75 years old or older.
I have type 2 diabetes that requires medication.
I have had a previous amputation or procedure for Peripheral Artery Disease.
I have had a blood vessel bypass with a graft.
I have a history of chronic kidney disease.
I have coronary artery disease.
My leg treatment involved stenting.
You may not be able to join if
I have a condition that requires long-term blood thinners.
I have a bleeding disorder or a very low platelet count.
I have had a recent heart procedure.
I have kidney problems that are severe or need dialysis.
I can't participate for the entire study period.
I am allergic to REGN7508, REGN9933, or rivaroxaban.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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:
* What side effects might happen from taking the study drugs and how do they compare to the side effects of rivaroxaban
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)
* If the study drugs affect the ability of the blood to clot normally
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
1. 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
2. At least 1 of the following enrichment factors for major thrombotic vascular events:
1. Bypass with pro…
Key Inclusion Criteria:
1. 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
2. At least 1 of the following enrichment factors for major thrombotic vascular events:
1. Bypass with prosthetic graft
2. Endovascular treatment with stenting
3. Target lesion length \>15 cm
4. History of LER or amputation for PAD prior to qualifying LER
5. Type 2 diabetes mellitus requiring pharmacologic treatment
6. Comorbid symptomatic coronary artery disease as described in the protocol
7. Chronic kidney disease as described in the protocol
8. Age ≥75 years
Key Exclusion Criteria:
1. Has any active clinical condition requiring chronic therapeutic anticoagulation after the index revascularization including known triple positive antiphospholipid syndrome
2. Has known bleeding diathesis, platelet count \<50,000/mm\^3 or history of non-traumatic intracerebral hemorrhage, known cerebral amyloid angiopathy, or known unrepaired cerebrovascular malformations
3. Has recent coronary revascularization as described in the protocol
4. For Cohort 2 only: Has estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73m\^2 within 14 days prior to randomization or on dialysis or expected to be started on dialysis within the next 12 weeks starting from randomization
5. Has any other condition or therapy which would make the participant unsuitable for this study or not allow participation for the full planned study period
6. Has allergy, hypersensitivity, or other contraindication to REGN7508, REGN9933, or rivaroxaban (Cohort 2 only) or their excipients
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
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