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Not yet recruitingNCT07876492ROXI-DAISENUpdated Oct 15, 2026

A Study to Evaluate Cenvacibart (REGN7508) for Secondary Stroke Prevention in Adult Participants

A Phase 3 interventional study of Cenvacibart and Placebo in Secondary Stroke, sponsored by Regeneron Pharmaceuticals. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Prevention

Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
6,106
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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
02

Conditions studied

  • 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
  • Second stroke
  • Previous stroke
  • History of stroke
  • Cerebrovascular accident
  • Cerebral stroke
  • Ischaemic stroke
  • Major Adverse Limb Event (MALE)
03

In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's planned enrollment of 6,106 is above the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 409 studies on the registry; 92 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 79 (64%) have results posted.

Browse Regeneron Pharmaceuticals studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Has a recent onset of neurological deficit attributed to non-cardioembolic focal brain ischemia as described in the protocol
  2. Has index event (non-cardioembolic, non-procedural ischemic stroke, or high-risk TIA) within 30 days prior to randomization as described in the protocol
  3. Is planned to receive antiplatelet therapy for secondary stroke prevention in line with local guidelines and practice
  4. 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:

  1. Has any active clinical condition requiring chronic outpatient therapeutic anticoagulation including history of atrial fibrillation or flutter and mechanical heart valves requiring anticoagulation
  2. 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
  3. Before index stroke, has modified rankin scale (mRS) score >3
  4. 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

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
6,106 participants (estimated)

Study arms

  • Experimental
    Cenvacibart

    Drug: Cenvacibart

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugCenvacibart

    Administered per the protocol

    Also known as: REGN7508

  • DrugPlacebo

    Administered per the protocol

06

What researchers measure

Primary outcomes

  1. Time to first occurrence of ischemic stroke

    Time frame: Approximately 33 months

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

    Time frame: Approximately 33 months

Secondary outcomes

  1. Total (first and subsequent) ischemic strokes

    Time frame: Approximately 33 months

  2. Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type)

    Time frame: Approximately 33 months

  3. Time to first occurrence of disabling stroke (ischemic, hemorrhagic, or of unspecified type)

    Time frame: Approximately 33 months

  4. Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or TIA

    Time frame: Approximately 33 months

  5. Time to first occurrence of TIA

    Time frame: Approximately 33 months

  6. Time to all-cause death

    Time frame: Approximately 33 months

  7. 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

  8. Time to first occurrence of ischemic stroke, MI, or all-cause death

    Time frame: Approximately 33 months

  9. 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

  10. Time to first occurrence of VTE

    Time frame: Approximately 33 months

  11. Time to first occurrence of ischemic stroke or ISTH major bleeding

    Time frame: Approximately 33 months

  12. Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), MI, ISTH major bleeding, or CV death

    Time frame: Approximately 33 months

  13. 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

  14. Time to first occurrence of ISTH major or ISTH clinically relevant non-major bleeding

    Time frame: Approximately 33 months

  15. Total ISTH major or ISTH clinically relevant non-major bleeding events

    Time frame: Approximately 33 months

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

    Time frame: Approximately 36 months

  17. Severity of TEAEs

    Time frame: Approximately 36 months

  18. Occurrence of Anti-Drug Antibodies (ADAs) to cenvacibart

    Time frame: Approximately 33 months

  19. Magnitude of ADAs to cenvacibart

    Time frame: Approximately 33 months

  20. Concentrations of cenvacibart

    Time frame: Approximately 33 months

  21. Change in activated Partial Thromboplastin Time (aPTT)

    Time frame: Approximately 33 months

  22. Change in Prothrombin Time (PT)

    Time frame: Approximately 33 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: When Regeneron has: received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) the legal authority to share the data, and ensured the ability to protect participant privacy

Access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07876492
Lead sponsor
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 15, 2026
Start date
Nov 20, 2026 (estimated)
Primary completion
Dec 15, 2029 (estimated)
Completion
Dec 15, 2029 (estimated)
Last update
Oct 15, 2026

Study contacts

Clinical Trials Administrator
Contact
clinicaltrials@regeneron.com
844-734-6643
Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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