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REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Sponsor: Regeneron Pharmaceuticals
Summary
This study is researching an experimental drug called REGN7508 versus Acetylsalicylic Acid (ASA) (each called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement 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 total knee replacement surgery compared to acetylsalicylic acid. 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 study drug less effective or could lead to side effects)
Official title: A Phase 3, Multicenter, Double-Blinded, Randomized Study to Evaluate REGN7508, a Factor XI Monoclonal Antibody, Versus Acetylsalicylic Acid for Prophylaxis of Symptomatic Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-ASPEN)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2000
Start Date
2025-11-24
Completion Date
2027-07-16
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
REGN7508
Administered per the protocol
Acetylsalicylic Acid (ASA)
Administered per the protocol
Placebo
Administered per the protocol
Locations (13)
Eisenhower Medical Center
Rancho Mirage, California, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Medical Research of Westchester - MPLUS Research Network
Miami, Florida, United States
Phoenix Clinical Research
Tamarac, Florida, United States
NextStage Clinical Research, St. Francis Medical Park
Wichita, Kansas, United States
Sinai Hospital of Baltimore, Inc.
Baltimore, Maryland, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Coastal Vascular Institute, PA
Wilmington, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Ohio Clinical Trials
Columbus, Ohio, United States
HD Research - Memorial Hermann Village
Houston, Texas, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Spokane Joint Replacement Center
Spokane, Washington, United States