Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Posterior Circulation Large Vessel Occlusion Stroke (IRIS-3)

Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Posterior Circulation Large Vessel Occlusion Stroke: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial-3

This is an investigator-initiated phase III clinical trial employing a randomized, double-blind, placebo-controlled design. The primary objective of this study is to investigate the efficacy and safety of an interleukin-6 inhibitor (tocilizumab) combined with endovascular therapy in patients with acute posterior circulation large-vessel occlusion stroke.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Drug: Tocilizumab; Drug: Placebo

Detailed Description

This is an investigator-initiated, prospective, multicenter phase III clinical trial. This trial aims to investigate whether tocilizumab could further improve prognosis for patients with acute posterior circulation large-vessel occlusion stroke receiving endovascular therapy.

• Study Type: Interventional
• Enrollment (Estimated): 348
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xunming Ji; Phone Number: 01083198962; Email: jixm@ccmu.edu.cn
• Study Contact Backup: Name: Chuanjie Wu; Phone Number: 01083199439; Email: wuchuanjie@ccmu.edu.cn

Study Locations

• China
  • Beijing, China, 100053
    • Recruiting
    • Capital Medical Univercity Xuanwu Hospital
  • Anhui
    • Suzhou, Anhui, China, 234000
      • Recruiting
      • Suzhou Municipal Hospital
      • Contact: Zhengfei Ma
  • Henan
    • Anyang, Henan, China, 455000
      • Recruiting
      • Anyang People's Hospital
      • Contact: Jiangang Zhang
    • Nanyang, Henan, China, 473000
      • Recruiting
      • Nanyang Central Hospital
      • Contact: Yifeng Liu
    • Xinxiang, Henan, China, 453000
      • Recruiting
      • The First Affiliated Hospital of Henan Medical University
      • Contact: Hongkai Cui
    • Zhoukou, Henan, China, 466600
      • Recruiting
      • People's Hospital of Xihua
      • Contact: Chaoqun Li
  • Shandong
    • Linyi, Shandong, China, 276000
      • Recruiting
      • People's Hospital of Linyi
      • Contact: Hao Wang
    • Zibo, Shandong, China, 255000
      • Recruiting
      • Zibo Central Hospital
      • Contact: Liangjie Wang
  • Shanxi
    • Xianyang, Shanxi, China, 712000
      • Recruiting
      • Xianyang First People's Hospital
      • Contact: Xingyun Yuan
    • Yuncheng, Shanxi, China, 044000
      • Recruiting
      • Yuncheng Central Hospital
      • Contact: Bin Wang
  • Zhejiang
    • Lishui, Zhejiang, China, 323000
      • Recruiting
      • Lishui Central Hospital
      • Contact: Xiao Peng
    • Taizhou, Zhejiang, China, 318000
      • Recruiting
      • Taizhou enze Hospital
      • Contact: Shaoqing Jiang
    • Yueqing, Zhejiang, China, 325600
      • Recruiting
      • People's Hospital of Yueqing
      • Contact: Saizhen Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 years or older, of either sex;
2. Acute ischemic stroke caused by occlusion of the basilar artery;
3. Decide to undergo emergency endovascular treatment;
4. Time from stroke onset to groin puncture within 24 hours;
5. National Institutes of Health Stroke Scale (NIHSS) ≥ 10;
6. Posterior circulation Alberta Stroke Program Early computed tomography score (pc-ASPECTS) ≥ 6;
7. 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 ≥180 mmHg or diastolic blood pressure ≥110 mmHg despite blood pressure control;
8. Neutrophils < 2 × 10^9 /L;
9. Platelets < 100 × 10^9 /L;
10. Blood glucose <2.8 mmol/L (50 mg/dL) or >22.2 mmol/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. Any circumstance that, as assessed by the investigators, might result in harm to the patients if study therapy is initiated;
20. Other conditions that the investigator considers might affect compliance or preclude participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tocilizumab; Endovascular treatment combined with a 240mg tocilizumab injection once	Drug: Tocilizumab; 240 mg of tocilizumab injection will be diluted in 0.9% NaCl to a total 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.
Placebo Comparator: Placebo; Endovascular treatment combined with placebo	Drug: Placebo; An equivalent volume of placebo will be diluted in 0.9% NaCl to a total 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 days.	The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Barthel Index (BI) 95-100 at 90 days		90 days
mRS score distribution at 90 days;	The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.	90 days
Early neurological improvement at 24 hours	Defined as a reduction in NIHSS score of at least 8 points from baseline or a score of 0 to 2	24 hours
NIHSS score at 7 days or at early discharge	The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes	7 days
Proportion of patients with mRS score 0-1 at 90 days	The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.	90 days
Proportion of patients with mRS score 0-2 at 90 days	The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.	90 days
Proportion of patients with mRS score 0-4 at 90 days	The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.	90 days
EQ-5D-5L at 90 days	The EQ-5D-5L comprises the same five dimensions: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION, each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems.	90 days

Other Outcome Measures

Outcome Measure	Time Frame
Mortality at 90 days	90 days
Incidence of symptomatic intracranial hemorrhage within 24 hours	24 hours
Incidence of any intracranial hemorrhage within 24 hours	24 hours
Proportion of patients with pneumonia at 7 days or at early discharge	7 days

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2026
• Primary Completion (Estimated): April 20, 2027
• Study Completion (Estimated): April 20, 2027

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: endovascular treatment; neuroprotection; large vessel occlusion; posterior circulation; interleukin-6 inhibitor
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; tocilizumab
• Other Study ID Numbers: IRIS-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No