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Taking people in United KingdomPhase 3

Factor XI antibodies REGN7508 and REGN9933 after leg artery procedures in peripheral artery disease

Tests REGN7508 and REGN9933 against rivaroxaban or placebo in peripheral artery disease after leg revascularization.

Key facts

Who runs it
Regeneron Pharmaceuticals
Where
Doncaster and London, United KingdomSee the 2 sitesAlso in 20 other countries, 124 sites
Registry title
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Status
Recruiting
Phase
Phase 3
People taking part
7,050 people, planned
Started
10 Jul 2026
Expected to end
16 Nov 2029
Type of study
Interventional, 2 groups
Treatments tested
  • REGN7508
  • REGN9933
  • Placebo
  • Rivaroxaban
Record updated
5 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with peripheral artery disease (narrowed blood vessels in the limbs) who recently had a procedure to improve blood flow in the legs.

Age
18 Years and older.
Sex
All sexes can join.
Disease stage
Symptomatic peripheral artery disease caused by hardened, narrowed arteries (atherosclerosis). A successful procedure to restore leg blood flow, below the external iliac artery, within 10 days before joining. At least 1 extra risk factor is needed: bypass with an artificial graft, a stent, a treated narrowing longer than 15 cm (5.9 in), an earlier leg procedure or amputation for PAD, type 2 diabetes treated with medicine, symptomatic heart artery disease, chronic kidney disease, or age 75 years or more.
Earlier treatment
A successful lower leg blood flow procedure (LER) within 10 days before joining is required. People with a recent heart artery procedure cannot join.

Main reasons for not taking part

  • A condition needing long-term blood thinner treatment, including known triple positive antiphospholipid syndrome.
  • A known bleeding disorder, platelet count <50,000/mm^3, or past brain bleeding not caused by injury.
  • Known cerebral amyloid angiopathy or unrepaired blood vessel malformations in the brain.
  • Cohort 2 only: eGFR <15 mL/min/1.73m^2, on dialysis, or expected to start dialysis within 12 weeks.
  • Allergy or other reason not to take REGN7508, REGN9933, or rivaroxaban (Cohort 2 only).

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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:; Bypass with prosthetic graft; Endovascular treatment with stenting; Target lesion length >15 cm; History of LER or amputation for PAD prior to qualifying LER; Type 2 diabetes mellitus requiring pharmacologic treatment; Comorbid symptomatic coronary artery disease as described in the protocol; Chronic kidney disease as described in the protocol; Age ≥75 years

Who cannot take part

  • Has any active clinical condition requiring chronic therapeutic anticoagulation after the index revascularization including known triple positive antiphospholipid syndrome
  • 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
  • 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
  • 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
  • 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
  • Has recent coronary revascularization as described in the protocol

Where in United Kingdom

Also in 20 other countries, 124 sites

  • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation TrustDoncaster, United KingdomContact: Clinical Trials AdministratorTaking people
  • Charing Cross HospitalLondon, United KingdomContact: Clinical Trials AdministratorTaking people

About the trial

What the trial wants 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 the legs and feet.

Read full original descriptionShow less

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

The 2 groups in the trial

  • Cohort 1Treatment being tested

    Treatment: REGN7508, REGN9933, and Placebo

  • Cohort 2Treatment being tested

    Treatment: REGN7508, REGN9933, and Rivaroxaban

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Master Protocol for a Phase 3, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, in Participants With Recent Lower Extremity Revascularization for Symptomatic Peripheral Artery Disease (ROXI-PALISADE)
Plain-language title
Factor XI antibodies REGN7508 and REGN9933 after leg artery procedures in peripheral artery diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
5 November 2026