A Master Protocol for a Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention with REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, versus Placebo in Participants with Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable (ROXI-INCLINE)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521618-25-00

Enrollment

237

Registered

2026-09-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-30

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

Conditions

Atrial Fibrillation (AF)

Brief summary

Time to first occurrence of ischemic stroke or systemic embolism, Time to first occurrence of ISTH major bleeding

Detailed description

Time to first occurrence of Major Adverse Cardiovascular Event (MACE), Time to first occurrence of MACE, pulmonary embolism, or Venous Thromboembolism (VTE), Time to first occurrence of ischemic stroke, Time to Cardiovascular (CV) death, Time to all-cause death, Occurrence of Treatment-Emergent Adverse Events (TEAEs), Severity of TEAEs, Concentrations of REGN7508 over time, Concentrations of REGN9933 over time, Change from baseline in activated Partial Thromboplastin Time (aPTT) over time, Change from baseline in Prothrombin time (PT)/International Normalized Ratio (INR) over time, Occurrence of Anti-Drug Antibody (ADA) to REGN7508 over time, Magnitude of ADA to REGN7508 over time, Occurrence of ADA to REGN9933 over time, Magnitude of ADA to REGN9933 over time

Interventions

DRUGPlacebo product (PP) and drug product (DP) components are identical

DRUGexcept for purified protein

DRUGREGN7508

DRUGPlacebo product

DRUGREGN9933

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to first occurrence of ischemic stroke or systemic embolism, Time to first occurrence of ISTH major bleeding	—

Secondary

Measure	Time frame
Time to first occurrence of Major Adverse Cardiovascular Event (MACE), Time to first occurrence of MACE, pulmonary embolism, or Venous Thromboembolism (VTE), Time to first occurrence of ischemic stroke, Time to Cardiovascular (CV) death, Time to all-cause death, Occurrence of Treatment-Emergent Adverse Events (TEAEs), Severity of TEAEs, Concentrations of REGN7508 over time, Concentrations of REGN9933 over time, Change from baseline in activated Partial Thromboplastin Time (aPTT) over time, Change from baseline in Prothrombin time (PT)/International Normalized Ratio (INR) over time, Occurrence of Anti-Drug Antibody (ADA) to REGN7508 over time, Magnitude of ADA to REGN7508 over time, Occurrence of ADA to REGN9933 over time, Magnitude of ADA to REGN9933 over time	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 1, 2026