REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants (ROXI-ASPEN)

Regeneron Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Symptomatic Venous Thromboembolism (VTE)

Treatments: Drug: Placebo; Drug: Acetylsalicylic Acid (ASA); Drug: REGN7508

Study type: Interventional

Funder types: Industry

Identifiers

NCT07213778

R7508-DVT-24120

2025-520479-25-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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)

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Is undergoing a primary elective unilateral TKA
2. Is in good health based on laboratory safety testing as described in the protocol

Key Exclusion Criteria:

1. Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation
2. History of bleeding in the 6 months prior to randomization 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 (eg, hemophilia A or B, von Willebrand's Factor deficiency)
3. History of thromboembolic disease or thrombophilia
4. History of platelet dysfunction
5. Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,000 participants in 2 patient groups

REGN7508 and Placebo

Experimental group

Treatment:

Drug: REGN7508

Drug: Placebo

Placebo and ASA

Active Comparator group

Treatment:

Drug: Acetylsalicylic Acid (ASA)

Drug: Placebo