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
- Are there results?
- Not yet: the study is under way
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
- 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
- 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
- Recruiting
Yutian County Hospital
Tangshan, Hebei, 064100
Haijun Li
- 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
- 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.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- 3 Nov 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07509645
- Acronym / sponsor ID
- IRIS-3 / IRIS-3
- Conditions
- Ischemic Stroke
- Keywords
- large vessel occlusion, endovascular treatment, posterior circulation, interleukin-6 inhibitor, neuroprotection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 20 Apr 2027 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | Experimental | Drug: TocilizumabEndovascular treatment combined with a 240mg tocilizumab injection once |
| Placebo | Placebo comparator | Drug: PlaceboEndovascular treatment combined with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tocilizumab240 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. | Drug | Tocilizumab |
| PlaceboAn 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. | Drug | Placebo |
Primary outcome
Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 days.
Time frame: 90 days
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
8 secondary outcomes
mRS score distribution
Time frame: 90 days and 1 year
Early neurological improvement at 24 hours
Time frame: 24 hours
NIHSS score at 7 days or at early discharge
Time frame: 7 days
Proportion of patients with mRS score 0-1
Time frame: 90 days and 1 year
Proportion of patients with mRS score 0-2
Time frame: 90 days and 1 year
Proportion of patients with mRS score 0-4
Time frame: 90 days and 1 year
EQ-5D-5L
Time frame: 90 days and 1 year
Proportion of Barthel Index (BI) 95-100
Time frame: 90 days and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tocilizumab in people with Ischemic Stroke, run by Capital Medical University at 30 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji (01083198962, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 days. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.