Peripheral Artery Disease (PAD)Phase 3ROXI-PALISADENCT07318610
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
A Phase 3 study testing REGN7508, REGN9933 and Rivaroxaban in people with Peripheral Artery Disease (PAD), run by Regeneron Pharmaceuticals at 29 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease (PAD)
- What is being tested?
- REGN7508, REGN9933 and Rivaroxaban
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,050 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 10 Jul 2026to 16 Nov 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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 join
- Has any active clinical condition requiring chronic therapeutic anticoagulation after the index revascularization including known triple positive antiphospholipid syndrome
- 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
- Has recent coronary revascularization as described in the protocol
- 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 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
Trial locations and contacts
29 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
29 sites in 2 countries
United States27 sites, 27 recruiting
- Recruiting
Advanced Cardiovascular
Alexander City, Alabama, 35010
- Recruiting
Lake Martin Medical and Vascular Center
Alexander City, Alabama, 35010
- Recruiting
PharmaTex Research
Amarillo, Texas, 79106
- Recruiting
Axsendo Clinical Research, Integrated Medical Services
Avondale, Arizona, 85392
- Recruiting
Mecklenburg Heart Specialists Vascular Institute and Vein Center
Charlotte, North Carolina, 28207
- Recruiting
Nature Coast Clinical Research - Cardiology
Crystal River, Florida, 34429
- Recruiting
Vital Heart and Vein
Cypress, Texas, 77429
- Recruiting
Epic Medical Research
DeSoto, Texas, 75115
- Recruiting
Advanced Heart and Vascular Institute of Hunterdon
Flemington, New Jersey, 08822
- Recruiting
Lutheran Medical Group LLC dba Lutheran Health Physicians
Fort Wayne, Indiana, 46804
- Recruiting
ASHA Clinical Research Munster, LLC
Hammond, Indiana, 46324
- Recruiting
Apex Research Foundation, LLC
Jackson, Tennessee, 38301
- Recruiting
Tennova TCMC
Knoxville, Tennessee, 37934
- Recruiting
Applied Research Center of Arkansas
Little Rock, Arkansas, 72205
- Recruiting
Angel City Research, Inc.
Los Angeles, California, 90010
- Recruiting
Accellacare of Piedmont, Piedmont Healthcare
Mooresville, North Carolina, 28117
- Recruiting
Profound Research, Powers Health Medical Group
Munster, Indiana, 46321
- Recruiting
Hightower Clinical
Oklahoma City, Oklahoma, 73102
- Recruiting
Pacific Cardiovascular and Vein Institute
Oxnard, California, 93036
- Recruiting
Cardiovascular Institute of Northwest Florida, Main Office
Panama City, Florida, 32405
- Recruiting
Rovia Clinical Research - Hattiesburg Clinic
Petal, Mississippi, 39465
- Recruiting
Epic Medical Research-Plano
Plano, Texas, 75093
- Recruiting
Monument Health Clinical Research
Rapid City, South Dakota, 57701
- Recruiting
Cardiovascular Solutions
Shreveport, Louisiana, 71103
- Recruiting
Tampa Cardiovascular Interventions and Research
Tampa, Florida, 33614
- Recruiting
Vanderbilt Heart and Vascular Tullahoma, Cardiology and Vascular Associates
Tullahoma, Tennessee, 37388
- Recruiting
Interventional Cardiology Medical Group
West Hills, California, 91307
United Kingdom2 sites, 2 recruiting
- Recruiting
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, DN2 5LT
- Recruiting
Charing Cross Hospital
London, W6 8RF
About this study
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)
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.
Read more
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
- Conditions
- Peripheral Artery Disease (PAD)
- Being tested
- REGN7508, REGN9933, Placebo, Rivaroxaban
- Keywords
- Blood clots, Lower Extremity Revascularization (LER)
- Medical subject headings
- Peripheral Arterial Disease, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN7508Drug
Also called cenvacibart
Administered per the protocol
REGN9933Drug
Also called amrecibart
Administered per the protocol
PlaceboDrug
Administered per the protocol
RivaroxabanDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: REGN7508; Drug: REGN9933; Drug: Placebo |
| Cohort 2 | Experimental | Not described Receives: Drug: REGN7508; Drug: REGN9933; Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Approximately up to 42 months
Secondary outcomes (26)
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
Measured: 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
Measured: 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
Measured: Approximately up to 42 months
Time-to-first occurrence of vascular hospitalization for a coronary cerebrovascular, or peripheral event of thrombotic nature
Cohort 1
Measured: 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
Measured: Approximately up to 42 months
Time-to-first occurrence of unplanned index limb revascularization for ischemia
Cohort 1
Measured: Approximately up to 42 months
Time-to-first occurrence of VTE
Cohort 1
Measured: Approximately up to 42 months
Time-to-all-cause mortality
Cohort 1
Measured: Approximately up to 42 months
Time-to-first occurrence of Major Adverse Limb Event (MALE)
Cohort 1
Measured: Approximately up to 42 months
Time-to-first occurrence of Major Adverse Cardiovascular Event (MACE)
Cohort 1
Measured: 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
Measured: Approximately up to 42 months
Time-to-first occurrence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding
Cohort 1 and 2
Measured: Approximately up to 42 months
Occurrence of Treatment-Emergent Adverse Event (TEAEs)
Cohort 1 and 2
Measured: Approximately up to 45 months
Severity of TEAEs
Cohort 1 and 2
Measured: Approximately up to 45 months
Occurrence of Anti-Drug Antibody (ADA) to REGN7508 over time
Cohort 1 and 2
Measured: Approximately up to 45 months
Magnitude of ADA to REGN7508 over time
Cohort 1 and 2
Measured: Approximately up to 45 months
Occurrence of ADA to REGN9933 over time
Cohort 1 and 2
Measured: Approximately up to 45 months
Magnitude of ADA to REGN9933 over time
Cohort 1 and 2
Measured: Approximately up to 45 months
Concentrations of REGN7508 over time
Cohort 1 and 2
Measured: Approximately up to 45 months
Concentrations of REGN9933 over time
Cohort 1 and 2
Measured: Approximately up to 45 months
Change from baseline in activated Partial Thromboplastin Time (aPTT) over time
Cohort 1 and 2
Measured: Approximately up to week 9
Change from baseline in Prothrombin Time (PT)/International Normalization Ratio (INR) over time
Cohort 1 and 2
Measured: Approximately up to week 9
Total (first and subsequent) occurrences of expanded thrombotic vascular events
Cohort 2
Measured: Approximately up to 42 months
Time-to-first occurrence of a major thrombotic vascular event
Cohort 2
Measured: 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
Measured: 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
Measured: Approximately up to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start10 Jul 2026
- Primary completion18 Aug 2029 (estimated)
- Study completion16 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery Disease (PAD)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318610
- Sponsor's protocol ID
- R9933-PAD-2394
- Other IDs
- 2025-522954-37-00, 2025
- Acronym
- ROXI-PALISADE
- Status last verified
- Oct 2026
- First submitted
- 2 Jan 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.