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

Not Applicable

Not yet recruiting

• Conditions: Symptomatic Venous Thromboembolism (VTE)
• Interventions: Drug: REGN7508; Drug: Acetylsalicylic Acid (ASA); Drug: Placebo

• Registration Number: NCT07213778
• Lead Sponsor: Regeneron Pharmaceuticals

Brief 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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-10-03
• Study First Submitted QC: 2025-10-03
• Last Update Submitted: 2025-10-03
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Study Start: 2025-12-05
• Primary Completion: 2027-07-16
• Study Completion: 2027-07-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REGN7508 and Placebo	REGN7508	-
REGN7508 and Placebo	Placebo	-
Placebo and ASA	Acetylsalicylic Acid (ASA)	-
Placebo and ASA	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of the composite endpoint of symptomatic VTE and VTE-related death	Through day 30 visit

Secondary Outcome Measures

Name	Time	Method
Incidence of confirmed symptomatic Deep Vein Thrombosis (DVT)	Through day 30 visit
Incidence of confirmed Pulmonary Embolism (PE)	Through day 30 visit
Time to first event of confirmed PE	Through day 30 visit
Time to VTE-related death	Through day 30 visit
Incidence of the composite endpoint of major bleeding and Clinically Relevant Non-Major (CRNM) bleeding	Through day 30 visit
Severity of TEAEs	Through day 90 visit
Incidence of Anti-drug Antibody (ADA) to REGN7508	Through day 90 visit
Incidence of VTE-related death	Through day 30 visit
Time to first event of the composite endpoint of symptomatic VTE and VTE-related death	Through day 30 visit
Time to first event of confirmed symptomatic DVT	Through day 30 visit
Incidence of minor bleeding	Through day 30 visit
Incidence of Treatment-Emergent Adverse Events (TEAEs)	Through day 90 visit
Magnitude of ADA to REGN7508	Through day 90 visit
Concentrations of REGN7508	Through day 90 visit