MedPath

REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults

Phase 3
Recruiting
Conditions
Venous Thromboembolism (VTE)
Interventions
Registration Number
NCT07015905
Lead Sponsor
Regeneron Pharmaceuticals
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 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.

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

Recruitment & Eligibility

Status
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
  3. Body weight ≤130 kg at screening visit 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 as described in the protocol
  3. History of thromboembolic disease or thrombophilia
  4. History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization
  5. Has an estimated Glomerular Filtration Rate (GFR) of <30 mL/min/1.73 m2 at the screening visit as described in the protocol

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
IV Placebo, enoxaparinEnoxaparin-
IV Placebo, enoxaparinPlacebo-
IV REGN7508REGN7508-
IV Placebo, SC REGN7508REGN7508-
IV Placebo, SC REGN7508Placebo-
IV Placebo, apixabanApixaban-
IV Placebo, apixabanPlacebo-
Primary Outcome Measures
NameTimeMethod
Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death]Through day 12 visit, approximately 14 days
Secondary Outcome Measures
NameTimeMethod
Incidence of confirmed symptomatic Deep Venous Thrombosis (DVT)Through day 12 visit, approximately 14 days
Incidence of confirmed Pulmonary Embolism (PE)Through day 12 visit, approximately 14 days
Incidence of VTE-related deathThrough day 12 visit, approximately 14 days
Incidence of the composite endpoint of major and clinically relevant non-major (CRNM) bleedingThrough day 12 visit, approximately 14 days
Incidence of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death)Through day 12 visit, approximately 14 days
Incidence of minor bleedingThrough day 12 visit, approximately 14 days
Incidence of Treatment Emergent Adverse Events (TEAEs)Approximately day 90
Incidence of Anti-Drug Antibodies (ADA) to REGN7508Approximately day 90
Titer of ADA to REGN7508Approximately day 90
Concentrations of REGN7508Approximately day 90

Trial Locations

Locations (1)

Phoenix Clinical Research

🇺🇸

Tamarac, Florida, United States

Phoenix Clinical Research
🇺🇸Tamarac, Florida, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.