REGN7508 and REGN9933 for Peripheral Artery Disease

Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease

Recruiting Phase 3 Interventional 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.
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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.

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About This Trial
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 …
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…
Contacts

Clinical Trials Administrator

844-734-6643

clinicaltrials@regeneron.com

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