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Atrial Fibrillation (AF)Phase 3ROXI-INCLINENCT07430956

Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable

A Phase 3 study testing REGN7508 and REGN9933 in people with Atrial Fibrillation (AF), run by Regeneron Pharmaceuticals at 44 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation (AF)
What is being tested?
REGN7508 and REGN9933
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,628 participants
Where
44 sitesin 2 countries
Study dates
3 Apr 2026to 26 Jun 2029
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 [C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Systemic embolism (double points); V: Vascular disease; A: Age 65-74 years] score ≥4 OR
  • CHA2DS2-VA score of 3 AND at least 1 enrichment criteria as described in the protocol
  • Shared decision making between the participant and provider determining that the bleeding risk of Oral Anticoagulant (OAC) therapy outweighs the benefits, making the participant unsuitable for OAC therapy as described in the protocol

Who cannot join

  • 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 Central Nervous System (CNS) bleeding within 30 days prior to randomization
  • Has a life expectancy less than 12 months
  • Has participated in a prior Factor XI (FXI) inhibitor study
  • Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Trial locations and contacts

44 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

44 sites in 2 countries

United States43 sites, 43 recruiting

  • PharmaTex Research

    Amarillo, Texas, 79106

    Recruiting

  • AnMed Health

    Anderson, South Carolina, 29621

    Recruiting

  • Atlanta Clinical Research Centers

    Atlanta, Georgia, 30342

    Recruiting

  • Profound Research, Cardiology and Vascular Associates (CAVA) - Bloomfield Hills

    Bloomfield Hills, Michigan, 48304

    Recruiting

  • PanAmerican Clinical Research

    Brownsville, Texas, 78520

    Recruiting

  • Hawthorne Health, Moose Pharmacy of Concord

    Concord, North Carolina, 28025

    Recruiting

  • Southwest Family Medicine Associates

    Dallas, Texas, 75235

    Recruiting

  • SEC Clinical Research

    Dothan, Alabama, 36305

    Recruiting

  • Profound Research, Millennium Cardiology

    Farmington Hills, Michigan, 48334

    Recruiting

  • Flint Clinical Research

    Flint, Michigan, 48503

    Recruiting

  • AA Medical Research Center (MRC)

    Flint, Michigan, 48504

    Recruiting

  • Mission Cardiovascular Research Institute

    Fremont, California, 94538

    Recruiting

  • Sun City Clinical Research

    Glendale, Arizona, 85351

    Recruiting

  • East Texas Cardiology

    Houston, Texas, 77002

    Recruiting

  • Synergy Group Medical,LLC

    Houston, Texas, 77036

    Recruiting

  • Synergy Groups Medical

    Houston, Texas, 77061

    Recruiting

  • National Institute of California Heart and Vein Specialists

    Huntington Beach, California, 92648

    Recruiting

  • Franciscan Physician Network, Indiana Heart Physicians

    Indianapolis, Indiana, 46237

    Recruiting

  • Jackson Heart Clinic

    Jackson, Mississippi, 39216

    Recruiting

  • East Coast Institute for Research, Jacksonville

    Jacksonville, Florida, 32216

    Recruiting

  • NSC Research, Inc

    Johns Creek, Georgia, 30024

    Recruiting

  • Profound Research LLC at San Diego Cardiovascular Associates

    La Jolla, California, 92037

    Recruiting

  • Arkansas Cardiology P.A.

    Little Rock, Arkansas, 72205

    Recruiting

  • Heart Institute of East Texas

    Lufkin, Texas, 75901

    Recruiting

  • K&R Research LLC

    Marion, Ohio, 43302

    Recruiting

  • Texas Institute of Cardiology PA

    McKinney, Texas, 75071

    Recruiting

  • South Florida Research Organization LLC

    Medley, Florida, 33166

    Recruiting

  • Indiana Medical Research

    Merrillville, Indiana, 46410

    Recruiting

  • Synergy Group Medical, LLC

    Missouri City, Texas, 77459

    Recruiting

  • Profound Research, Powers Health Medical Group - Electrophysiology

    Munster, Indiana, 46321

    Recruiting

  • Valley Clinical Trials, LLC dba Flourish Research

    Northridge, California, 91325

    Recruiting

  • Profound Research LLC at Southern California Heart Specialists

    Pasadena, California, 91105

    Recruiting

  • Sec Clinical Research

    Pensacola, Florida, 32503

    Recruiting

  • Monument Health Clinical Research

    Rapid City, South Dakota, 57701

    Recruiting

  • FOMAT - Comprehensive Cardiovascular Care

    Santa Maria, California, 93454

    Recruiting

  • Cardiovascular Center of Sarasota Foundation for Research and Education

    Sarasota, Florida, 34239

    Recruiting

  • Super Health Pharmacy

    Staten Island, New York, 10309

    Recruiting

  • Tennessee Center for Clinical Trials

    Tullahoma, Tennessee, 37388

    Recruiting

  • Cardiology Associates Medical Group

    Ventura, California, 93003

    Recruiting

  • Conquest Research

    Vienna, Virginia, 22182

    Recruiting

  • Interventional Cardiology Medical Group

    West Hills, California, 91307

    Recruiting

  • Monroe Research, LLC

    West Monroe, Louisiana, 71291

    Recruiting

  • Clinical Site Partners, LLC DBA Flourish Research

    Winter Park, Florida, 32789

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • Hamilton Medical Research Group (HMRG)

    Hamilton, Ontario, L8L 5G4

    Recruiting

Other trials in Canada

About this study

Official title: 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)

This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. When this happens, blood cannot move smoothly through the heart; it can slow down or pool in one spot, which can lead to the formation of blood clots.

REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation. The aim of the study is to see how effective and safe REGN7508 and REGN9933, individually, are in preventing ischemic stroke or systemic embolism in people with atrial fibrillation who cannot or may choose to not take blood thinners.

Read more

The study is looking at several other research questions, including:

  • What side effects may happen from taking REGN7508 or REGN9933
  • How well does REGN7508 or REGN9933 lower the risk of having an ischemic stroke and/or systemic embolism compared to the placebo
  • How well does REGN7508 or REGN9933 lower the risk of having a major health problem affecting heart and blood circulation compared to placebo
  • How well does REGN7508 or REGN9933 lower the risk of death compared to placebo
  • How much REGN7508 or REGN9933 is in the blood at different times
  • Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the study drugs less effective or could lead to side effects)
Being tested
REGN7508, REGN9933, Placebo
Keywords
Blood clots, Ischemic stroke, Systemic embolism, Pulmonary embolism, Venous Thromboembolism (VTE)
Medical subject headings
Atrial Fibrillation, Thrombosis, Ischemic Stroke, Pulmonary Embolism, Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REGN7508Drug

    Also called cenvacibart

    Administered per the protocol

  • REGN9933Drug

    Also called amrecibart

    Administered per the protocol

  • PlaceboDrug

    Administered per the protocol

Study groups in NCT07430956
Study groupRoleWhat they receive
REGN7508ExperimentalNot described
Receives: Drug: REGN7508
REGN9933ExperimentalNot described
Receives: Drug: REGN9933
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first occurrence of ischemic stroke or systemic embolism

    Measured: Up to 36 months

  2. Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding

    Measured: Up to 36 months

Secondary outcomes (15)

  1. Time to first occurrence of Major Adverse Cardiovascular Event (MACE)

    Measured: Up to 36 months

  2. Time to first occurrence of MACE, pulmonary embolism, or Venous Thromboembolism (VTE)

    Measured: Up to 36 months

  3. Time to first occurrence of ischemic stroke

    Measured: Up to 36 months

  4. Time to Cardiovascular (CV) death

    Measured: Up to 36 months

  5. Time to all-cause death

    Measured: Up to 36 months

  6. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Measured: Up to 39 months

  7. Severity of TEAEs

    Measured: Up to 39 months

  8. Concentrations of REGN7508 over time

    Measured: Up to 36 months

  9. Concentrations of REGN9933 over time

    Measured: Up to 36 months

  10. Change from baseline in activated Partial Thromboplastin Time (aPTT) over time

    Measured: Up to approximately 9 weeks

  11. Change from baseline in Prothrombin time (PT)/International Normalized Ratio (INR) over time

    Measured: Up to approximately 9 weeks

  12. Occurrence of Anti-Drug Antibody (ADA) to REGN7508 over time

    Measured: Up to 36 months

  13. Magnitude of ADA to REGN7508 over time

    Measured: Up to 36 months

  14. Occurrence of ADA to REGN9933 over time

    Measured: Up to 36 months

  15. Magnitude of ADA to REGN9933 over time

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2026
  2. Study start3 Apr 2026
  3. Primary completion28 Mar 2029 (estimated)
  4. Study completion26 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,628 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07430956
Sponsor's protocol ID
R9933-CVA-2495
Other IDs
2025-521618-25-00, 2025
Acronym
ROXI-INCLINE
Status last verified
Oct 2026
First submitted
18 Feb 2026
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

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