NCT06454630CompletedPhase 2
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)
Regeneron Pharmaceuticals28 sites in 5 countries179 target enrollmentStarted: June 27, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 179
- Locations
- 28
- Primary Endpoint
- Incidence of confirmed, adjudicated VTE
Study Overview
Brief Summary
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
REGN7508
Experimental
Intervention: REGN7508 (Drug)
Enoxaparin
Active Comparator
Intervention: Enoxaparin (Drug)
Outcomes
Primary Outcomes
Incidence of confirmed, adjudicated VTE
Time Frame: Through day 12
Secondary Outcomes
- Incidence of major bleeding(Up to approximately Day 12)
- Incidence of clinically relevant non-major (CRNM) bleeding(Up to approximately Day 12)
- Incidence of treatment emergent adverse events (TEAEs)(Through end of study; approximately Day 75)
- Incidence of major VTE(Through day 12)
- Incidence of Deep venous thrombosis (DVT)(Approximately Day 12)
- Concentrations of REGN7508 in serum(Through end of study; approximately Day 75)
- Change in activated partial thromboplastin time (aPTT)(Baseline to end of study; approximately Day 75)
- Change in prothrombin time (PT)(Baseline to end of study; approximately Day 75)
- Incidence of anti-drug antibodies (ADA) to REGN7508(Through end of study; approximately Day 75)
- Titer of ADA to REGN7508(Through end of study; approximately Day 75)
Investigators
Study Sites (28)
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