A Phase 3, Multicenter, Double-Blinded, Randomized Study to Evaluate REGN7508, a Factor XI Monoclonal Antibody, Versus Acetylsalicylic Acid for Prophylaxis of Symptomatic Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-ASPEN)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520479-25-00

Enrollment

Registered

2026-04-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-01

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

Conditions

Symptomatic Venous Thromboembolism (VTE)

Brief summary

Incidence of the composite endpoint of symptomatic VTE and VTE-related death

Detailed description

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

Interventions

DRUGPlacebo for Acetylsalicylic Acid

DRUGACETYLSALICYLIC ACID

DRUGREGN7508

DRUGPlacebo for REGN7508

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of the composite endpoint of symptomatic VTE and VTE-related death	—

Secondary

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

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 2, 2026