Secondary StrokePhase 3ROXI-DAISENNCT07876492
A Study to Evaluate Cenvacibart (REGN7508) for Secondary Stroke Prevention in Adult Participants
A Phase 3 study testing Cenvacibart in people with Secondary Stroke, run by Regeneron Pharmaceuticals.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Stroke
- What is being tested?
- Cenvacibart
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,106 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2026to 15 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 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
Who cannot join
- Has any active clinical condition requiring chronic outpatient therapeutic anticoagulation including history of atrial fibrillation or flutter and mechanical heart valves requiring anticoagulation
- 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
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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)
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).
Read more
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
- Conditions
- Secondary Stroke
- Being tested
- Cenvacibart, Placebo
- Keywords
- Secondary stroke prevention (SSP), Recurrent stroke, Stroke recurrence, Recurrent ischemic stroke, Prevention of recurrent stroke, Stroke prevention after stroke, Preventing another stroke, Repeat stroke, Second stroke, Previous stroke, History of stroke, Cerebrovascular accident, Cerebral stroke, Ischaemic stroke, Major Adverse Limb Event (MALE)
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenvacibartDrug
Also called REGN7508
Administered per the protocol
PlaceboDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Cenvacibart | Experimental | Not described Receives: Drug: Cenvacibart |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first occurrence of ischemic stroke
Measured: Approximately 33 months
Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding
Measured: Approximately 33 months
Secondary outcomes (22)
Total (first and subsequent) ischemic strokes
Measured: Approximately 33 months
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type)
Measured: Approximately 33 months
Time to first occurrence of disabling stroke (ischemic, hemorrhagic, or of unspecified type)
Measured: Approximately 33 months
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or TIA
Measured: Approximately 33 months
Time to first occurrence of TIA
Measured: Approximately 33 months
Time to all-cause death
Measured: Approximately 33 months
Time to first occurrence of Major Adverse Cardiovascular Event (MACE) 3 (ischemic stroke, Myocardial Infarction [MI], or cardiovascular [CV] death)
Measured: Approximately 33 months
Time to first occurrence of ischemic stroke, MI, or all-cause death
Measured: Approximately 33 months
Time to first occurrence of MACE 4 (ischemic stroke, MI, CV death, or arterial revascularization procedure), systemic embolism, MALE (acute limb ischemia or major amputation [above the ankle] of vascular etiology), or venous thromboembolism (VTE)
Measured: Approximately 33 months
Time to first occurrence of VTE
Measured: Approximately 33 months
Time to first occurrence of ischemic stroke or ISTH major bleeding
Measured: Approximately 33 months
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), MI, ISTH major bleeding, or CV death
Measured: Approximately 33 months
Time to first occurrence of disabling stroke (ischemic, hemorrhagic, or of unspecified type), symptomatic intracranial hemorrhage, or all-cause death
Measured: Approximately 33 months
Time to first occurrence of ISTH major or ISTH clinically relevant non-major bleeding
Measured: Approximately 33 months
Total ISTH major or ISTH clinically relevant non-major bleeding events
Measured: Approximately 33 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Approximately 36 months
Severity of TEAEs
Measured: Approximately 36 months
Occurrence of Anti-Drug Antibodies (ADAs) to cenvacibart
Measured: Approximately 33 months
Magnitude of ADAs to cenvacibart
Measured: Approximately 33 months
Concentrations of cenvacibart
Measured: Approximately 33 months
Change in activated Partial Thromboplastin Time (aPTT)
Measured: Approximately 33 months
Change in Prothrombin Time (PT)
Measured: Approximately 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start20 Nov 2026 (estimated)
- Primary completion15 Dec 2029 (estimated)
- Study completion15 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary StrokeStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 6,106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876492
- Sponsor's protocol ID
- R7508-SSP-2642
- Other IDs
- 2026-527406-20-00
- Acronym
- ROXI-DAISEN
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07876492
- Acronym / sponsor ID
- ROXI-DAISEN / R7508-SSP-2642
- Conditions
- Secondary Stroke
- Keywords
- Secondary stroke prevention (SSP), Recurrent stroke, Stroke recurrence, Recurrent ischemic stroke, Prevention of recurrent stroke, Stroke prevention after stroke, Preventing another stroke, Repeat stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,106 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2026 (estimated)
- Primary completion
- 15 Dec 2029 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cenvacibart | Experimental | Drug: Cenvacibart |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Has any active clinical condition requiring chronic outpatient therapeutic anticoagulation including history of atrial fibrillation or flutter and mechanical heart valves requiring anticoagulation
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CenvacibartAlso: REGN7508Administered per the protocol | Drug | Cenvacibart |
| PlaceboAdministered per the protocol | Drug | Placebo |
Primary outcome
Time to first occurrence of ischemic stroke
Time frame: Approximately 33 months
Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding
Time frame: Approximately 33 months
22 secondary outcomes
Total (first and subsequent) ischemic strokes
Time frame: Approximately 33 months
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type)
Time frame: Approximately 33 months
Time to first occurrence of disabling stroke (ischemic, hemorrhagic, or of unspecified type)
Time frame: Approximately 33 months
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or TIA
Time frame: Approximately 33 months
Time to first occurrence of TIA
Time frame: Approximately 33 months
Time to all-cause death
Time frame: Approximately 33 months
Time to first occurrence of Major Adverse Cardiovascular Event (MACE) 3 (ischemic stroke, Myocardial Infarction [MI], or cardiovascular [CV] death)
Time frame: Approximately 33 months
Time to first occurrence of ischemic stroke, MI, or all-cause death
Time frame: Approximately 33 months
Time to first occurrence of MACE 4 (ischemic stroke, MI, CV death, or arterial revascularization procedure), systemic embolism, MALE (acute limb ischemia or major amputation [above the ankle] of vascular etiology), or venous thromboembolism (VTE)
Time frame: Approximately 33 months
Time to first occurrence of VTE
Time frame: Approximately 33 months
Time to first occurrence of ischemic stroke or ISTH major bleeding
Time frame: Approximately 33 months
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), MI, ISTH major bleeding, or CV death
Time frame: Approximately 33 months
Time to first occurrence of disabling stroke (ischemic, hemorrhagic, or of unspecified type), symptomatic intracranial hemorrhage, or all-cause death
Time frame: Approximately 33 months
Time to first occurrence of ISTH major or ISTH clinically relevant non-major bleeding
Time frame: Approximately 33 months
Total ISTH major or ISTH clinically relevant non-major bleeding events
Time frame: Approximately 33 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Approximately 36 months
Severity of TEAEs
Time frame: Approximately 36 months
Occurrence of Anti-Drug Antibodies (ADAs) to cenvacibart
Time frame: Approximately 33 months
Magnitude of ADAs to cenvacibart
Time frame: Approximately 33 months
Concentrations of cenvacibart
Time frame: Approximately 33 months
Change in activated Partial Thromboplastin Time (aPTT)
Time frame: Approximately 33 months
Change in Prothrombin Time (PT)
Time frame: Approximately 33 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cenvacibart in people with Secondary Stroke, run by Regeneron Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first occurrence of ischemic stroke (time frame: Approximately 33 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.