NCT07876492Not yet recruitingPhase 3
A Study to Evaluate Cenvacibart (REGN7508) for Secondary Stroke Prevention in Adult Participants
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate Cenvacibart (REGN7508), a Monoclonal Antibody Against Factor XI, for Secondary Stroke Prevention (ROXI-DAISEN)
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
This study will test an experimental Regeneron drug called cenvacibart (REGN7508) ("study drug") compared with a placebo (a look-alike treatment with no active medicine) on top of background antiplatelet medications. The purpose of this study is to find out if cenvacibart can safely reduce the risk of another ischemic stroke or another blood clot related events in people who have recently had an ischemic stroke or mini-stroke (TIA). The study is looking at: * How well cenvacibart works * What side effects cenvacibart might cause * How much cenvacibart is in the blood at different times * How the body reacts to cenvacibart * How cenvacibart could affect the blood which can help researchers understand why cenvacibart works better in some people than others
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 6106 (estimated)
- First submitted
- 9 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Dec 2029
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Stroke
- NCT number
- NCT07876492
- EU CT number
- 2026-527406-20-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 6106
- From Nov 2026 to the primary completion date, Dec 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has any active clinical condition requiring chronic outpatient therapeutic anticoagulation including history of atrial fibrillation or flutter and mechanical heart valves requiring anticoagulation
- Before index stroke, has modified rankin scale (mRS) score \>3
- Has known intracranial vascular abnormality with high risk for bleeding (treated aneurysm and aneurysm \<5 mm are not exclusionary)
- Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Other
- Has had strokes due to non-thrombotic causes (eg, bacterial endocarditis, vertebral or carotid artery dissection), caused by procedures (eg, in the setting of coronary artery bypass grafting), or secondary to hypotension
Who the study is looking for
- Has a recent onset of neurological deficit attributed to non-cardioembolic focal brain ischemia as described in the protocol
- Has index event (non-cardioembolic, non-procedural ischemic stroke, or high-risk TIA) within 30 days prior to randomization as described in the protocol
- Is planned to receive antiplatelet therapy for secondary stroke prevention in line with local guidelines and practice
- In case of endovascular therapy (mechanical thrombectomy) and/or thrombolysis, randomization can only occur \>24 hours after endovascular therapy or after thrombolysis as described in the protocol
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.