Actively Recruiting
A Phase 3 Study to Evaluate REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, in Adults With Peripheral Artery Disease After Lower Extremity Revascularization
Led by Regeneron Pharmaceuticals · Updated on 2026-05-22
7050
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two experimental drugs, REGN7508 and REGN9933, in adults with Peripheral Artery Disease (PAD), a condition where blood vessels in the arms and legs narrow. The study focuses on participants who have recently undergone Lower Extremity Revascularization (LER), a procedure to restore blood flow in the legs and feet. The goal is to see how well these drugs prevent dangerous blood clots compared to rivaroxaban and a placebo, while also assessing side effects and the body's response to the drugs. Participants will receive one of the study drugs—REGN7508, REGN9933, rivaroxaban, or a placebo—administered according to the study protocol. The trial is randomized and blinded to ensure fair comparison. The study lasts for up to about 42 months, during which researchers will monitor blood drug levels, immune responses that might affect drug effectiveness, and clotting ability changes. Safety and antibody formation will be closely tracked through approximately 45 months. During the study, participants will have regular assessments including blood tests to measure clotting times and drug concentrations. Researchers will track major thrombotic events like acute limb ischemia, heart attacks, strokes, amputations, and cardiovascular deaths. Bleeding events and adverse effects will also be monitored. The study aims to gather comprehensive data on the safety and effectiveness of these treatments in preventing life-threatening clots in people with PAD after LER.
CONDITIONS
Brief Title
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Successful Lower Extremity Revascularization (LER) distal to the external iliac artery for ischemia due to atherosclerotic disease within 10 days prior to randomization
- At least one of the following risk factors: bypass with prosthetic graft, endovascular treatment with stenting, target lesion length greater than 15 cm, prior LER or amputation for PAD, type 2 diabetes requiring medication, symptomatic coronary artery disease, chronic kidney disease, or age 75 years or older
You will not qualify if you...
- Need for ongoing therapeutic anticoagulation after the index revascularization, including known triple positive antiphospholipid syndrome
- Known bleeding disorders, platelet count less than 50,000/mm³, history of non-traumatic intracerebral hemorrhage, cerebral amyloid angiopathy, or unrepaired cerebrovascular malformations
- Recent coronary revascularization as defined by the protocol
- For Cohort 2 only: estimated Glomerular Filtration Rate (eGFR) less than 15 mL/min/1.73m² within 14 days prior to randomization, on dialysis, or expected to start dialysis within 12 weeks
- Any other condition or treatment making participation unsuitable for the full study duration
- Allergy or contraindication to REGN7508, REGN9933, rivaroxaban (Cohort 2 only), or their ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately up to 42 months
Participants receive investigational monoclonal antibodies REGN7508 and REGN9933, or placebo, along with rivaroxaban per protocol, to reduce adverse vascular outcomes after lower extremity revascularization.
Regular visits throughout treatment period per protocol
Duration - Up to 3 months after treatment ends (approximately up to 45 months total from start)
Participants are monitored for safety, adverse events, and clinical outcomes after completing treatment.
Visits as scheduled for safety and outcome assessments
Trial Site Locations
Total: 1 location
1
PharmaTex Research
Amarillo, Texas, United States, 79106
Actively Recruiting
Research Team
C
Clinical Trials Administrator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here