Ischemic StrokePhase 3IRIS-3NCT07509645
Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Posterior Circulation Large Vessel Occlusion Stroke
A Phase 3 study testing Tocilizumab in people with Ischemic Stroke, run by Capital Medical University at 30 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 348 participants
- Where
- 30 sitesChina
- Study dates
- 22 Apr 2026to 20 Apr 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older, of either sex;
- Acute ischemic stroke caused by occlusion of the basilar artery;
- Decide to undergo emergency endovascular treatment;
- Time from stroke onset to groin puncture within 24 hours;
- National Institutes of Health Stroke Scale (NIHSS) ≥ 10;
- Posterior circulation Alberta Stroke Program Early computed tomography score (pc-ASPECTS) ≥ 6;
- Signed informed consent from the patients or the legally authorized representatives.
Who cannot join
- 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;
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- Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg despite blood pressure control;
- Neutrophils < 2 × 10^9 /L;
- Platelets < 100 × 10^9 /L;
- Blood glucose <2.8 mmol/L (50 mg/dL) or >22.2 mmol/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;
- Presence of autoimmune diseases or use of immunosuppressive drugs;
- Systemic infectious diseases;
- Participation in another interventional clinical study within 30 days before randomization or currently participating in another interventional clinical study;
- Any circumstance that, as assessed by the investigators, might result in harm to the patients if study therapy is initiated;
- Other conditions that the investigator considers might affect compliance or preclude participation in this study.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
China30 sites, 30 recruiting
- Recruiting
Anyang People's Hospital
Anyang, Henan, 455000
Jiangang Zhang
- Recruiting
Capital Medical Univercity Xuanwu Hospital
Beijing, 100053
- Recruiting
Liuyang Jili Hospital
Guankou, Hunan, 410300
Yuzhang Bei
- Recruiting
Junxian People's Hospital
Hebi, Henan, 456250
Beibei Jiang
- Not yet recruiting
Heyuan People's Hospital
Heyuan, Guangdong, 517000
Guanghong Zhong
- Recruiting
Suixi County Hospital
Huaibei, Anhui, 235100
Jianqiao Li
- Recruiting
Jiaxing First People's Hospital
Jiaxing, Zhejiang, 314000
Junjie Xu
- Recruiting
People's Hospital of Linyi
Linyi, Shandong, 276000
Hao Wang
- Recruiting
Lishui Central Hospital
Lishui, Zhejiang, 323000
Xiao Peng
- Not yet recruiting
Luoyang Central Hospital
Luoyang, Henan, 471000
Wenbo Li
- Recruiting
Huazhou People's Hospital
Maoming, Guangdong, 525100
Yanbo Huang
- Recruiting
Nanyang Central Hospital
Nanyang, Henan, 473000
Yifeng Liu
- Recruiting
Puyang Oiled General Hospital
Puyang, Henan, 457000
Yutie Zhao
- Recruiting
Qinhuangdao Second People's Hospital
Qinhuangdao, Hebei, 066000
- Recruiting
Shangqiu First People's Hospital
Shangqiu, Henan, 476000
Quande Dai
- Recruiting
Ningling County Hospital
Shangqiu, Henan, 476700
Xiaoyin Liu
- Recruiting
Suzhou Municipal Hospital
Suzhou, Anhui, 234000
Zhengfei Ma
- Recruiting
Taizhou enze Hospital
Taizhou, Zhejiang, 318000
Shaoqing Jiang
- Recruiting
Tangshan Gongren Hospital
Tangshan, Hebei, 063000
Jing Liu
- Not yet recruiting
Yutian County Hospital
Tangshan, Hebei, 064100
Haijun Li
- Not yet recruiting
Wenzhou People's Hospital
Wenzhou, Zhejiang, 325000
Cheng Zhang
- Not yet recruiting
Xiangyang First People's Hospital
Xiangyang, Hubei, 441000
Xiaolong Li
- Recruiting
Xianyang First People's Hospital
Xianyang, Shanxi, 712000
Xingyun Yuan
- Recruiting
The First Affiliated Hospital of Henan Medical University
Xinxiang, Henan, 453000
Hongkai Cui
- Not yet recruiting
Yancheng First People's Hospital
Yancheng, Jiangsu, 224000
Xiaofeng Qu
- Recruiting
People's Hospital of Yueqing
Yueqing, Zhejiang, 325600
Saizhen Wu
- Recruiting
Yuncheng Central Hospital
Yuncheng, Shanxi, 044000
Bin Wang
- Recruiting
Shenqiu County Hospital
Zhoukou, Henan, 466300
Yanling Li
- Recruiting
People's Hospital of Xihua
Zhoukou, Henan, 466600
Chaoqun Li
- Recruiting
Zibo Central Hospital
Zibo, Shandong, 255000
Liangjie Wang
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Tocilizumab, Placebo
- Keywords
- large vessel occlusion, endovascular treatment, posterior circulation, interleukin-6 inhibitor, neuroprotection
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Experimental | Endovascular treatment combined with a 240mg tocilizumab injection once Receives: Drug: Tocilizumab |
| Placebo | Placebo comparator | Endovascular treatment combined with placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (8)
mRS score distribution
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Measured: 90 days and 1 year
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
Measured: 24 hours
NIHSS score at 7 days or at early discharge
The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes
Measured: 7 days
Proportion of patients with mRS score 0-1
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Measured: 90 days and 1 year
Proportion of patients with mRS score 0-2
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Measured: 90 days and 1 year
Proportion of patients with mRS score 0-4
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Measured: 90 days and 1 year
EQ-5D-5L
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.
Measured: 90 days and 1 year
Proportion of Barthel Index (BI) 95-100
Measured: 90 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start22 Apr 2026
- Primary completion20 Apr 2027 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509645
- Sponsor's protocol ID
- IRIS-3
- Acronym
- IRIS-3
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.