Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Anterior Circulation Large Vessel Occlusion Stroke -2
IRIS-2
1 other identifier
interventional
692
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2025
Shorter than P25 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2025
CompletedFirst Posted
Study publicly available on registry
December 4, 2025
CompletedStudy Start
First participant enrolled
December 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
December 11, 2025
December 1, 2025
1.2 years
November 23, 2025
December 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
modified Rankin Scale (mRS) score at 90 days
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
90 days
Secondary Outcomes (10)
Proportion of patients with mRS score 0-2 at 90 days
90 days
Proportion of patients with mRS score 0-1 at 90 days
90 days
National Institutes of Health Stroke Scale (NIHSS) score at 7 days or at early discharge
7 days or at early discharge
Infarct volume at 24 hours
24 hours
EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) at 90 days
90 days
- +5 more secondary outcomes
Study Arms (2)
Tocilizumab group
EXPERIMENTALEndovascular treatment combined 240 mg tocilizumab injection once.
Placebo group
PLACEBO COMPARATOREndovascular treatment combined equivalent volume of placebo once.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age 18 years or greater, male or female;
- Acute ischemic stroke caused by occlusion of intracranial segment of the internal carotid artery, middle cerebral artery M1 or proximal/dominant M2 segment;
- Decided to undergo emergency endovascular treatment;
- Time from stroke onset to arterial puncture within 24 hours;
- National Institutes of Health Stroke Scale (NIHSS) score ≥ 6;
- Signed informed consent from the patients or the legally authorized representatives.
You may not qualify if:
- Intracerebral hemorrhage, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage;
- Pre-stroke modified Rankin scale (mRS) score \>1;
- Known allergy to tocilizumab or excipients;
- Known allergy to iodinated contrast agents;
- Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
- History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, or thrombocytopenic diseases;
- Systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg despite blood pressure control;
- Neutrophils \<2×109 /L;
- Platelets \<100×109 /L;
- Blood glucose \<2.8mmol/L (50 mg/dL) or \>22.2mmol/L (400 mg/dL);
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \>2 times the upper limit of normal;
- Known recent or current serum creatinine \>2 times the upper limit of normal or estimated glomerular filtration rate (eGFR) \<60 mL/min;
- Pregnant, lactating, or planning pregnancy within 90 days;
- Severe mental disorders or inability to comply with informed consent and follow-up requirements due to dementia;
- Concurrent malignant tumors or severe systemic diseases with expected survival of less than 90 days;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
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
Zhongxiang Traditional Chinese Medical Hospital
Zhongxiang, Wuhan, China
Xuanwu Hospital, Capital Medical University
Beijing, 100053, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurology, Xuanwu Hospital, Capital Medical University
Study Record Dates
First Submitted
November 23, 2025
First Posted
December 4, 2025
Study Start
December 5, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
December 11, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.