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Tocilizumab with endovascular clot removal for acute anterior large-vessel stroke

Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Anterior Circulation Large Vessel Occlusion Stroke: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial-2 (IRIS-2)

PHASE3 · Capital Medical University · NCT07263776

This trial will see if giving the anti-inflammatory drug tocilizumab along with endovascular clot removal helps adults with acute large-vessel anterior circulation ischemic stroke recover better than placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment692 (estimated)
Ages18 Years and up
SexAll
SponsorCapital Medical University (other)
Drugs / interventionstocilizumab
Locations53 sites (Suzhou, Anhui and 52 other locations)
Trial IDNCT07263776 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled phase 3 trial that enrolls adults with acute anterior circulation large vessel occlusion who are planned for emergency endovascular treatment. Participants are randomized 1:1 to receive either tocilizumab or placebo in addition to standard endovascular clot removal. Clinical follow-up visits occur immediately after the procedure, at 24 hours, 7 days, and at 90 days to monitor safety and recovery. The trial targets patients treated within 24 hours of stroke onset and uses standard stroke scales and imaging to track outcomes.

Who should consider this trial

Good fit: Adults aged 18 or older with acute ischemic stroke due to anterior circulation large vessel occlusion (ICA, M1, or dominant/proximal M2), NIHSS ≥ 6, and planned endovascular treatment within 24 hours are ideal candidates.

Not a fit: Patients with intracranial hemorrhage on imaging, pre-stroke disability (mRS > 1), known allergy to tocilizumab or contrast agents, bleeding disorders, or anticipated inability to complete endovascular treatment are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, adding tocilizumab could reduce post-reperfusion inflammation and improve functional recovery after thrombectomy.

How similar studies have performed: Using IL-6 receptor blockade in stroke is relatively novel with limited early-phase data suggesting potential anti-inflammatory benefit but no definitive large phase 3 positive results to date.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age 18 years or greater, male or female;
2. Acute ischemic stroke caused by occlusion of intracranial segment of the internal carotid artery, middle cerebral artery M1 or proximal/dominant M2 segment;
3. Decided to undergo emergency endovascular treatment;
4. Time from stroke onset to arterial puncture within 24 hours;
5. National Institutes of Health Stroke Scale (NIHSS) score ≥ 6;
6. Signed informed consent from the patients or the legally authorized representatives.

Exclusion Criteria:

1. Intracerebral hemorrhage, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage;
2. Pre-stroke modified Rankin scale (mRS) score \>1;
3. Known allergy to tocilizumab or excipients;
4. Known allergy to iodinated contrast agents;
5. Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
6. History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, or thrombocytopenic diseases;
7. Systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg despite blood pressure control;
8. Neutrophils \<2×109 /L;
9. Platelets \<100×109 /L;
10. Blood glucose \<2.8mmol/L (50 mg/dL) or \>22.2mmol/L (400 mg/dL);
11. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \>2 times the upper limit of normal;
12. Known recent or current serum creatinine \>2 times the upper limit of normal or estimated glomerular filtration rate (eGFR) \<60 mL/min;
13. Pregnant, lactating, or planning pregnancy within 90 days;
14. Severe mental disorders or inability to comply with informed consent and follow-up requirements due to dementia;
15. Concurrent malignant tumors or severe systemic diseases with expected survival of less than 90 days;
16. Presence of autoimmune diseases or use of immunosuppressive drugs;
17. Systemic infectious diseases;
18. Participation in another interventional clinical study within 30 days before randomization or currently participating in another interventional clinical study;
19. Considered by the investigator to have other conditions that might affect compliance or preclude participation in this study.

Where this trial is running

Suzhou, Anhui and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Acute Ischemic Stroke, Stroke, Interleukin-6 Receptor Inhibitor, Endovascular Treatment

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.