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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Anterior Circulation Large Vessel Occlusion Stroke -2

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)

Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Anterior Circulation Large Vessel Occlusion Stroke -2 (NCT07263776) is a Phase 3 interventional studying Acute Ischemic Stroke, sponsored by Capital Medical University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study is a randomized, double-blind, placebo-controlled clinical trial. Investigators aim to assess the efficacy and safety of interleukin-6 receptor inhibitor combined with endovascular treatment in patients with acute anterior circulation large vessel occlusion stroke.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Acute Ischemic Stroke, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 692 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form from the patients or the legally authorized representatives. Who Should NOT Join This Trial: 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 willing to sign a consent form 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 conditions (where your immune system attacks your own body)s or use of immunosuppressive drugs; 17. Systemic infectious diseases; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Tocilizumab

240 mg of tocilizumab injection will be diluted in 0.9% NaCl solution to prepare a total solution volume of 100 mL. The solution will be administered via intravenous infusion immediately after randomization, and no later than 30 minutes, with an infusion duration of more than 1 hour.

DRUG

Placebo

An equivalent volume of placebo will be diluted in 0.9% NaCl solution to prepare a total solution volume of 100 mL. The solution will be administered via intravenous infusion immediately after randomization, and no later than 30 minutes, with an infusion duration of more than 1 hour.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Si Country People's Hospital
Suzhou, Anhui, China
Lingshan County People's Hospital
Qinzhou, Guangxi, China
The second Hospital of Qinhuangdao
Qinhuangdao, Hebei, China
Yutian Hospital
Tangshan, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The People's Hospital of Anyang
Anyang, Henan, China
Jun County People's Hospital
Hebi, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Tianyou Hospital Affliated to Wuhan University of Science &Technology
Wuhan, Hubei, China
Xiangyang No.1 People's hospital
Xiangyang, Hubei, China
Xing'an league People's Hospital
Xing’an, Inner Mongolia, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
People's Hospital of Dongying
Dongying, Shandong, China
Linshu Country People's Hospital
Linyi, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
Qingdao Huangdao District Hospital of Traditional Chinese Medicine
Qingdao, Shandong, China
Yiyuan Country People's Hospital
Zibo, Shandong, China
Shanxi Medical University First Hospital
Taiyuan, Shanxi, China
The People's Hospital of Xianyang
Xianyang, Shanxi, China
Daliuta Experimental District People's Hospital of Shenmu City
Yulin, Shanxi, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07263776), the sponsor (Capital Medical University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07263776 clinical trial studying?

This study is a randomized, double-blind, placebo-controlled clinical trial. Investigators aim to assess the efficacy and safety of interleukin-6 receptor inhibitor combined with endovascular treatment in patients with acute anterior circulation large vessel occlusion stroke. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07263776?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07263776?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07263776. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07263776. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.