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

Conditions

• Symptomatic Venous Thromboembolism (VTE)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• REGN7508 — DRUG
  Administered per the protocol
• Acetylsalicylic Acid (ASA) — DRUG
  Administered per the protocol
• Placebo — DRUG
  Administered per the protocol

Study Details

This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called Acetylsalicylic Acid (ASA). 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)

Key Dates

Start date

Nov 24, 2025

Status verified

May 2026

Primary completion

May 17, 2027

Completion

Jul 16, 2027

Study Design

Enrollment

2,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: REGN7508 and Placebo
• Active Comparator: Placebo and ASA

Primary Outcome Measure

Incidence of the composite endpoint of symptomatic VTE and all-cause death [ Time Frame: Through day 30 visit ]

Central Contacts

• Clinical Trials Administrator
  844-734-6643
  [email protected]

Locations (19)

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