ROXI-INCLINE

Currently Recruiting: Participants and Sites

Study Drug/Intervention: REGN7508 and REGN9933

Anticipated Sample Size: 2,628 Participants

Study Timeline: This study is expected to conclude in December 2029.

ClinicalTrials.gov ID: NCT07430956

Objective

The ROXI-INCLINE study goal is to demonstrate that REGN7508 and REGN9933 are superior to placebo with respect to the risk of ischemic stroke or systemic embolism.

Inclusion Criteria

• Is ≥18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.
• Has AF or flutter (paroxysmal or persistent), not considered to be secondary to a reversible cause.
• At moderate to high risk for stroke, defined as:
  • CHA2DS2-VA score ≥4 OR
  • CHA2DS2-VA score of 3 AND at least 1 of the following enrichment criteria:
  • ≥75 years of age as a risk factor contributing to the score of 3
  • previous stroke, transient ischemic attack (TIA), or systemic embolism as a risk factor contributing to the score of 3
• Shared decision making between the participant and provider determining that the bleeding risk of OAC therapy outweighs the benefits, making the participant unsuitable for OAC therapy. At least 1 of the following criteria that contribute to this shared decision is required:
  • prior failure of OAC therapy (eg, previous use of OAC resulting in discontinuation due to bleeding events, concerns of bleeding events)
  • prior episode of non-traumatic major bleeding
  • renal dysfunction with CKD-EPI eGFR <15 mL/min/1.73m2 during screening OR renal dysfunction requiring dialysis
  • severe liver disease, including cirrhosis
  • history of falls or frailty
  • participant is unwilling to take OAC therapy due to bleeding risk AND this determination was made and documented prior to screening for the study and independently of the study.

Exclusion Criteria

• Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion).
• Had an ischemic stroke within 2 days prior to randomization.
• Has persistent, uncontrolled hypertension (per investigator’s discretion).
• Has a history of CNS bleeding within 30 days prior to randomization.
• Has a life expectancy less than 12 months.
• Has participated in a prior FXI inhibitor study.

Participants with AF for whom oral anticoagulation is unsuitable.

The overall study duration is expected to be approximately 39 months.

Regeneron Pharmaceuticals, Inc.

• Project PI: Manesh Patel, MD & Renato Lopes, MD

• Project PL: Yolanda Harris, MAFM