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

Phase 3

Recruiting

• Conditions: Venous Thromboembolism (VTE)
• Interventions: Drug: Enoxaparin; Drug: REGN7508; Drug: Apixaban; Drug: Placebo

• 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

Study Timeline

• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-03
• Study First Posted: 2025-06-11
• Study Start: 2025-06-25
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-18
• Primary Completion: 2027-02-20
• Study Completion: 2027-05-12

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

Group	Intervention	Description
IV Placebo, enoxaparin	Enoxaparin	-
IV Placebo, enoxaparin	Placebo	-
IV REGN7508	REGN7508	-
IV Placebo, SC REGN7508	REGN7508	-
IV Placebo, SC REGN7508	Placebo	-
IV Placebo, apixaban	Apixaban	-
IV Placebo, apixaban	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 death	Through day 12 visit, approximately 14 days
Incidence of the composite endpoint of major and clinically relevant non-major (CRNM) bleeding	Through 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 bleeding	Through day 12 visit, approximately 14 days
Incidence of Treatment Emergent Adverse Events (TEAEs)	Approximately day 90
Incidence of Anti-Drug Antibodies (ADA) to REGN7508	Approximately day 90
Titer of ADA to REGN7508	Approximately day 90
Concentrations of REGN7508	Approximately day 90

Trial Locations

Locations (1)

Phoenix Clinical Research; 🇺🇸 Tamarac, Florida, United States