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

NCT07318610 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: R9933-PAD-23942025-522954-37-00
• Study Type: interventional
• Target: 7,050
• Locations: 0 countries
• Sites: N/A

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)

Keywords

Blood clots; Lower Extremity Revascularization (LER)

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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

  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)

  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

  Approximately up to 42 months

• Time-to-first occurrence of vascular hospitalization for a coronary or peripheral event of thrombotic nature

  Approximately up to 42 months

• Time-to-first occurrence of ALI, major amputation of vascular etiology, MI, ischemic stroke, or all-cause mortality

  Approximately up to 42 months

Study Arms (2)

Cohort 1

EXPERIMENTAL

Drug: REGN7508; Drug: REGN9933; Drug: Placebo

Cohort 2

EXPERIMENTAL

Drug: REGN7508; Drug: REGN9933; Drug: Rivaroxaban

Interventions

REGN7508 DRUG

Administered per the protocol

Cohort 1; Cohort 2

REGN9933 DRUG

Administered per the protocol

Cohort 1; Cohort 2

Placebo DRUG

Administered per the protocol

Cohort 1

Rivaroxaban DRUG

Administered per the protocol

Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 enrichment factor 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 treatment
• Comorbid symptomatic coronary artery disease as described in the protocol
• Chronic kidney disease as described in the protocol
• Age ≥75 years

You may not qualify if:

• Has any active clinical condition requiring 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 Glomerular Filtration Rate (GFR) \<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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

MeSH Terms

Conditions

Peripheral Arterial Disease; Thrombosis

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Cohort 1 of this study is double-blinded, and for Cohort 2 the participants, sponsor, and the investigators will be blinded to REGN7508 or REGN9933, but rivaroxaban will be administered as open-label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 6, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): May 5, 2029
• Study Completion (Estimated): August 3, 2029
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf