NCT07263776Active, not recruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 692 (actual)
- First submitted
- 23 Nov 2025
- Start date
- 5 Dec 2025
- Primary completion date
- 18 Sept 2026
- Lead sponsor
- Capital Medical University
- Diseases
- Stroke
- NCT number
- NCT07263776
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 692
- From 5 Dec 2025 to the primary completion date, 18 Sept 2026
- 54 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent malignant tumors or severe systemic diseases with expected survival of less than 90 days;
- Participation in another interventional clinical study within 30 days before randomization or currently participating in another interventional clinical study;
Other illness
- 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;
- History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, or thrombocytopenic diseases;
- Severe mental disorders or inability to comply with informed consent and follow-up requirements due to dementia;
- Presence of autoimmune diseases or use of immunosuppressive drugs;
- Systemic infectious diseases;
- Considered by the investigator to have other conditions that might affect compliance or preclude participation in this study.
Lab values
- 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;
Other
- Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
- Systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg despite blood pressure control;
- Pregnant, lactating, or planning pregnancy within 90 days;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (54)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The People's Hospital of Anyang Coordinator of this site? Confirm its status | Anyang | China | Unknown status |
| Beijing Red Cross Emergency Medical Center Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Binzhou Medical University Hospital Coordinator of this site? Confirm its status | Binzhou | China | Unknown status |
| People's Hospital of Dongying Coordinator of this site? Confirm its status | Dongying | China | Unknown status |
| The First Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Jun county people's hospital Coordinator of this site? Confirm its status | Hebi | China | Unknown status |
| Jiaozuo No.2 People's Hospital Coordinator of this site? Confirm its status | Jiaozuo | China | Unknown status |
| Jiaxing First Hospital Coordinator of this site? Confirm its status | Jiaxing | China | Unknown status |
| Jincheng People's Hospital Coordinator of this site? Confirm its status | Jincheng | China | Unknown status |
| JingDong ZhongMei Hospital Coordinator of this site? Confirm its status | Langfang | China | Unknown status |
| Linshu Country People's Hospital Coordinator of this site? Confirm its status | Linyi | China | Unknown status |
| Linyi People's Hospital Coordinator of this site? Confirm its status | Linyi | China | Unknown status |
| Lishui Central Hospital Coordinator of this site? Confirm its status | Lishui | China | Unknown status |
| Luoyang Central Hospital Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| Mengjin county people's hospital Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| Nantong First People's Hospital Coordinator of this site? Confirm its status | Nantong | China | Unknown status |
| Nanyang Nanshi Hospital Coordinator of this site? Confirm its status | Nanyang | China | Unknown status |
| Nanyang Second People's Hospital Coordinator of this site? Confirm its status | Nanyang | China | Unknown status |
| Tanghe County People's Hospital Coordinator of this site? Confirm its status | Nanyang | China | Unknown status |
| Nanyang Central Hospital Coordinator of this site? Confirm its status | Nanyang | China | Unknown status |
| Ningbo No.2 Hospital Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Ningbo Medical Center Lihuili Hospital Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Puyang Oilfield General Hospital Coordinator of this site? Confirm its status | Puyang | China | Unknown status |
| Qingdao Huangdao District Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| The Second Hospital of Qinhuangdao Coordinator of this site? Confirm its status | Qinhuangdao | China | Unknown status |
| Lingshan County People's Hospital Coordinator of this site? Confirm its status | Qinzhou | China | Unknown status |
| Ningling County People's Hospital Coordinator of this site? Confirm its status | Shangqiu | China | Unknown status |
| Shangqiu No.1 People's Hospital Coordinator of this site? Confirm its status | Shangqiu | China | Unknown status |
| Shenzhen Longhua District People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Suzhou Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Si Country People's Hospital Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Suixi County Hospital Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Shanxi Bethune Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Shanxi Medical University First Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University Coordinator of this site? Confirm its status | Taizhou | China | Unknown status |
| Yutian Hospital Coordinator of this site? Confirm its status | Tangshan | China | Unknown status |
| Tangshan Workers' Hospital Coordinator of this site? Confirm its status | Tangshan | China | Unknown status |
| Wenzhou People's Hospital Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Tianyou Hospital Affliated to Wuhan University of Science &Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Xiangyang No.1 People's Hospital Coordinator of this site? Confirm its status | Xiangyang | China | Unknown status |
| The People's Hospital of Xianyang Coordinator of this site? Confirm its status | Xianyang | China | Unknown status |
| Xing'an league People's Hospital Coordinator of this site? Confirm its status | Xing’an | China | Unknown status |
| The First Affiliated Hospital of Henan Medical University Coordinator of this site? Confirm its status | Xinxiang | China | Unknown status |
| Huixian People's Hospital Coordinator of this site? Confirm its status | Xinxiang | China | Unknown status |
| Xinxiang Central Hospital Coordinator of this site? Confirm its status | Xinxiang | China | Unknown status |
| Yueqing People's Hospital Coordinator of this site? Confirm its status | Yueqing | China | Unknown status |
| Daliuta Experimental District People's Hospital of Shenmu City Coordinator of this site? Confirm its status | Yulin | China | Unknown status |
| Zhangzhou Municipal Hospital Coordinator of this site? Confirm its status | Zhangzhou | China | Unknown status |
| Henan Provincial People's Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Zhongxiang Traditional Chinese Medical Hospital Coordinator of this site? Confirm its status | Zhongxiang | China | Unknown status |
| Xihua County People's Hospital Coordinator of this site? Confirm its status | Zhoukou | China | Unknown status |
| Yiyuan Country People's Hospital Coordinator of this site? Confirm its status | Zibo | China | Unknown status |
| Zibo Central hospital Coordinator of this site? Confirm its status | Zibo | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.