A Phase 3, Multicenter, Randomized, Open-Label, Sponsor-Blinded, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX).

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520478-20-00

Acronym

R7508-DVT-24116

Enrollment

1067

Registered

2025-10-08

Start date

2025-11-05

Completion date

Unknown

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolic disease

Brief summary

Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death].

Detailed description

Incidence of confirmed symptomatic Deep Venous Thrombosis (DVT)., Incidence of confirmed Pulmonary Embolism (PE)., Incidence of VTE-related death., Incidence of the composite endpoint of major and clinically relevant nonmajor (CRNM) bleeding., Incidence of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death)., Incidence of minor bleeding., Incidence of Treatment Emergent Adverse Events (TEAEs)., Incidence of Anti-Drug Antibodies (ADA) to REGN7508., Titer of ADA to REGN7508., Concentrations of REGN7508.

Interventions

DRUGCLEXANE 4 000 UI (40 mg)/0

DRUG4 ml solution injectable en seringue préremplie

DRUGEliquis 2.5 mg film-coated tablets

DRUGREGN7508

DRUGSODIUM CHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death].	—

Secondary

Measure	Time frame
Incidence of confirmed symptomatic Deep Venous Thrombosis (DVT)., Incidence of confirmed Pulmonary Embolism (PE)., Incidence of VTE-related death., Incidence of the composite endpoint of major and clinically relevant nonmajor (CRNM) bleeding., Incidence of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death)., Incidence of minor bleeding., Incidence of Treatment Emergent Adverse Events (TEAEs)., Incidence of Anti-Drug Antibodies (ADA) to REGN7508., Titer of ADA to REGN7508., Concentrations of REGN7508.	—

Measure

Time frame

—

Countries

Bulgaria, Hungary, Latvia, Lithuania, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026