Recruiting
Phase 3

REGN7508 & REGN9933

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07318610

Conditions

Peripheral Artery Disease (PAD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

REGN7508

REGN9933

Placebo

Rivaroxaban

Study Details

Brief 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. 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

Conditions

Peripheral Artery Disease (PAD)

Study ID

NCT07318610

Start date

Jul 10, 2026

Status verified date

Aug, 2026

Completion date

Nov 16, 2029

Anticipated

Primary completion date

Aug 18, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

7050 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

experimental: Cohort 2

Interventions

REGN7508

Administered per the protocol

REGN9933

Administered per the protocol

Placebo

Administered per the protocol

Rivaroxaban

Administered per the protocol

Primary outcome measure

  • 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 [ Time Frame: 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 [ Time Frame: Approximately up to 42 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Lake Martin Medical and Vascular Center

Recruiting

Alexander City, Alabama, United States, 35010

Axsendo Clinical Research, Integrated Medical Services

Recruiting

Avondale, Arizona, United States, 85392

Applied Research Center of Arkansas

Recruiting

Little Rock, Arkansas, United States, 72205

Angel City Research, Inc.

Recruiting

Los Angeles, California, United States, 90010

Pacific Cardiovascular and Vein Institute

Recruiting

Oxnard, California, United States, 93036

Nature Coast Clinical Research - Cardiology

Recruiting

Crystal River, Florida, United States, 34429

Profound Research, Powers Health Medical Group

Recruiting

Munster, Indiana, United States, 46321

Cardiovascular Solutions

Recruiting

Shreveport, Louisiana, United States, 71103

Accellacare of Piedmont, Piedmont Healthcare

Recruiting

Mooresville, North Carolina, United States, 28117

Hightower Clinical

Recruiting

Oklahoma City, Oklahoma, United States, 73102

Apex Research Foundation, LLC

Recruiting

Jackson, Tennessee, United States, 38301

Tennova TCMC

Recruiting

Knoxville, Tennessee, United States, 37934

Vanderbilt Heart and Vascular Tullahoma, Cardiology and Vascular Associates

Recruiting

Tullahoma, Tennessee, United States, 37388

PharmaTex Research

Recruiting

Amarillo, Texas, United States, 79106

Vital Heart and Vein

Recruiting

Cypress, Texas, United States, 77429

Epic Medical Research

Recruiting

DeSoto, Texas, United States, 75115

Epic Medical Research-Plano

Recruiting

Plano, Texas, United States, 75093

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Blood clots
  • Lower Extremity Revascularization (LER)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-08-19.