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Completed

NCT Number: NCT06454630

A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants

This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement (TKR) surgery.

The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related diseases after unilateral total knee replacement surgery.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Multi-profile Hospital for Active Treatment Hearth and Brain EAD, Pleven, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Undergoing a primary elective unilateral TKA
  • Has a body weight ≤130 kg at screening visit
  • Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECG's) performed at screening and/or prior to administration of initial dose of study drug as described in the protocol
  • Is in good health based on laboratory safety testing obtained during the screening period as described in the protocol

Key Exclusion Criteria:

  • History of bleeding in the past 6 months prior to dosing requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis
  • History of thromboembolic disease or thrombophilia
  • History of major surgery, including brain, spinal, or ocular, within approximately the past 6 months
  • History of major trauma within approximately the past 6 months prior to dosing
  • Hospitalized (>24 hours) for any reason within 30 days of the screening visit
  • Has an estimated glomerular filtration rate (GFR) of <45 mL/min/1.73m^2 at the screening visit using one of the following formulas: the Modification of Diet in Renal Disease (MDRD) equation, the Chronic Kidney Disease Epidemiology Collaboration equation, or equivalent equation

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Treatment and study plan

REGN7508

Drug

Administered by single intravenous (IV) dose

Enoxaparin

Drug

Administered by subcutaneous (SC) dose daily through the time of venography (or day 12, whichever is earlier)

Other names: Inhixa

Primary outcomes

  1. Percentage of Participants With Confirmed, Adjudicated Venous Thromboembolism (VTE)

    Time frame: Through day 12

    Composite endpoint that includes asymptomatic deep DVT (deep venous thrombosis) detected by unilateral venography of the operated leg; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal pulmonary embolism (PE) including unexplained death for which PE cannot be ruled out.

Secondary outcomes

  1. Number of Participants With Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding

    Time frame: Through day 12

    International Society on Thrombosis and Hemostasis (ISTH) criteria for Major Bleeding and CRNM Bleeding as described in the protocol

  2. Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE)

    Time frame: Through day 75

    A TEAE is any untoward medical occurrence in a participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.

  3. Percentage of Participants With Major VTE

    Time frame: Through day 12

    Major VTE is a composite endpoint that includes: proximal DVT; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal PE including unexplained death for which PE cannot be ruled out.

  4. Percentage of Participants With Deep Venous Thrombosis (DVT)

    Time frame: Through day 12

    DVT measured by venography of the operated leg

  5. Concentrations of Total REGN7508 in Serum

    Time frame: Days 1, 5, 10, 30 and 75

  6. Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT)

    Time frame: Days 1, 5, 10, 30, 75

    aPTT was used to measure the anticipated anticoagulant effect of REGN7508. Fold change is based on the follow-up value/baseline value within an arm.

  7. Fold Change From Baseline in Prothrombin Time (PT)

    Time frame: Days 1, 5, 10, 30, 75

    PT is a measure of extrinsic and/or common pathway function. Fold change is based on the follow-up value/baseline value within an arm.

  8. Number of Participants With Anti-REGN7508 Antibodies by Status

    Time frame: Through end of study; approximately Day 75

    Immunogenicity characterized by anti-drug antibody (ADA) status

  9. Number of Participants With Treatment-Emergent or Treatment-Boosted Anti-REGN7508 Antibodies by Maximum Titer

    Time frame: Through end of study; approximately Day 75

    Immunogenicity characterized per by ADA status

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2, Multicenter, Randomized, Open-Label, Active Control Study of REGN7508, a Factor XI Monoclonal Antibody, for Prevention of Venous Thromboembolism After Elective, Unilateral, Total Knee Arthroplasty (ROXI-VTE II)

Acronym: ROXI-VTE II

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 12, 2024
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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