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Study on REGN7508 for Preventing Blood Clots in Adults After Knee Replacement Surgery

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the prevention of blood clots, specifically venous thromboembolism, in patients who are undergoing a knee replacement surgery. The study will compare the effectiveness of a new treatment called REGN7508, which is a type of medication known as a monoclonal antibody, with an existing medication called enoxaparin sodium. Enoxaparin sodium is commonly used to prevent blood clots and is administered as a solution for injection.

The purpose of the study is to evaluate how well REGN7508 works in preventing blood clots after knee surgery. Participants in the study will receive either REGN7508 or enoxaparin sodium. Some participants may receive a placebo, which is a substance with no active medication. The study will monitor participants for any blood clots or bleeding events for about 12 days after surgery, and overall health will be observed for approximately 75 days.

Throughout the study, participants will have regular check-ups to ensure their safety and to monitor the effects of the treatment. The study aims to provide valuable information on the effectiveness and safety of REGN7508 in preventing blood clots in patients undergoing knee replacement surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will undergo a screening process to ensure eligibility. This includes a review of medical history, a physical examination, vital sign measurements, and electrocardiograms (ECGs).

    Laboratory safety tests will also be conducted to confirm good health status.

  2. Step 2

    Surgery and initial treatment

    The participant will undergo a primary elective unilateral total knee arthroplasty (TKA).

    Following the surgery, the participant will receive either REGN7508 or enoxaparin sodium as part of the study treatment.

  3. Step 3

    Medication administration

    REGN7508 is administered through intravenous use, while enoxaparin sodium is given via subcutaneous injection.

    The dosage for enoxaparin sodium is 4,000 IU (40 mg) in a 0.4 mL solution for injection.

  4. Step 4

    Monitoring period

    The participant will be monitored for the incidence of confirmed venous thromboembolism (VTE) through day 12.

    Additional monitoring includes checking for major bleeding, clinically relevant non-major bleeding, and treatment emergent adverse events (TEAEs) up to approximately day 75.

  5. Step 5

    Follow-up assessments

    The participant will undergo follow-up assessments to measure the concentration of REGN7508 in serum, changes in blood clotting times, and the presence of anti-drug antibodies (ADA) through the end of the study, approximately day 75.

Who can join the trial?

5 criteria

  • The patient must be having a **primary elective unilateral TKA**. This means they are having a planned surgery to replace one knee joint.
  • The patient must weigh **130 kg or less** at the screening visit.
  • The patient must be considered in **good health** by the study doctor. This is based on their medical history, a physical exam, checking vital signs like blood pressure and heart rate, and an **electrocardiogram (ECG)**, which is a test that checks the heart's electrical activity.
  • The patient must be in **good health** based on lab tests done during the screening period.
  • Both **male and female** patients can participate.

Who cannot join the trial?

3 criteria

  • Patients with a history of **thromboembolic disease** cannot participate. This means if you have had blood clots in your veins or arteries before, you are not eligible.
  • Patients who are not within the specified age range cannot participate. The study is only for certain age groups.
  • Patients who are part of a vulnerable population are not eligible. This refers to groups of people who might need special protection or care.
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Investigated drugs

  • REGN7508

    is a monoclonal antibody designed to target Factor XI. It is being studied for its potential to prevent venous thromboembolism, which is a condition where blood clots form in the veins, in patients who are undergoing elective, unilateral total knee replacement surgery. The goal is to see if this medication can effectively reduce the risk of blood clots compared to other treatments.

  • Enoxaparin

    is a medication commonly used to prevent and treat blood clots. It is often given to patients undergoing surgery to reduce the risk of developing venous thromboembolism. In this study, enoxaparin is used as a comparison to evaluate the effectiveness of REGN7508 in preventing blood clots after knee surgery.

What is already known about the treatment

REGN7508 – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in preventing venous thromboembolism, particularly in patients undergoing knee replacement surgery. It is a monoclonal antibody targeting Factor XI, which plays a role in blood clot formation. By inhibiting Factor XI, REGN7508 aims to reduce the risk of blood clots without significantly affecting normal blood clotting processes. It is classified as an anticoagulant agent and is still under investigation to determine its safety and efficacy compared to existing treatments like enoxaparin.

Investigated diseases

Thromboembolic disease – This condition involves the formation of blood clots that can obstruct blood vessels. It often occurs in veins, leading to venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT typically develops in the deep veins of the legs, causing pain and swelling. If a part of the clot breaks off, it can travel to the lungs, resulting in a PE, which can cause chest pain and difficulty breathing. The disease progresses as clots form and potentially dislodge, leading to complications. It is often associated with periods of immobility, surgery, or certain medical conditions that increase clotting risk.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508602-14-00Protocol codeR7508-DVT-2360Estimated enrolment180 patientsSponsorRegeneron Pharmaceuticals Inc.

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