Acute Ischemic StrokePhase 3IRIS-2NCT07263776
Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Anterior Circulation Large Vessel Occlusion Stroke -2
A Phase 3 study testing Tocilizumab in people with Acute Ischemic Stroke, run by Capital Medical University at 54 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute 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
- 692 participants
- Where
- 54 sitesChina
- Study dates
- 5 Dec 2025to 11 Jun 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 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.
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 ≥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;
- 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;
- Considered by the investigator to have other conditions that might affect compliance or preclude participation in this study.
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
China54 sites
The People's Hospital of Anyang
Anyang, Henan
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Beijing Red Cross Emergency Medical Center
Beijing
Binzhou Medical University Hospital
Binzhou, Shandong
People's Hospital of Dongying
Dongying, Shandong
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Jun County People's Hospital
Hebi, Henan
Jiaozuo No.2 People's Hospital
Jiaozuo, Henan
Jiaxing First Hospital
Jiaxing, Zhejiang
Jincheng People's Hospital
Jincheng, Shanxi
JingDong ZhongMei Hospital
Langfang, Hebei
Linshu Country People's Hospital
Linyi, Shandong
Linyi People's Hospital
Linyi, Shandong
Lishui Central Hospital
Lishui, Zhejiang
Luoyang Central Hospital
Luoyang, Henan
Mengjin County People's Hospital
Luoyang, Henan
Nantong First People's Hospital
Nantong, Jiangsu
Nanyang Central Hospital
Nanyang, Henan
Nanyang Nanshi Hospital
Nanyang, Henan
Nanyang Second People's Hospital
Nanyang, Henan
Tanghe County People's Hospital
Nanyang, Henan
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang
Ningbo NO.2 Hospital
Ningbo, Zhejiang
Puyang Oilfield General Hospital
Puyang, Henan
Qingdao Huangdao District Hospital of Traditional Chinese Medicine
Qingdao, Shandong
The second Hospital of Qinhuangdao
Qinhuangdao, Hebei
Lingshan County People's Hospital
Qinzhou, Guangxi
Ningling County People's Hospital
Shangqiu, Henan
Shangqiu No.1 People's Hospital
Shangqiu, Henan
Shenzhen Longhua District People's Hospital
Shenzhen
Si Country People's Hospital
Suzhou, Anhui
Suixi County Hospital
Suzhou, Anhui
Suzhou Hospital of Anhui Medical University
Suzhou, Anhui
Shanxi Bethune Hospital
Taiyuan, Shanxi
Shanxi Medical University First Hospital
Taiyuan, Shanxi
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Taizhou, Zhejiang
Tangshan Workers Hospital
Tangshan, Hebei
Yutian Hospital
Tangshan, Hebei
Wenzhou People's Hospital
Wenzhou, Zhejiang
Tianyou Hospital Affliated to Wuhan University of Science &Technology
Wuhan, Hubei
Xiangyang No.1 People's hospital
Xiangyang, Hubei
The People's Hospital of Xianyang
Xianyang, Shanxi
Xing'an league People's Hospital
Xing’an, Inner Mongolia
Huixian People's Hospital
Xinxiang, Henan
The First Affiliated Hospital of Henan Medical University
Xinxiang, Henan
Xinxiang Central Hospital
Xinxiang, Henan
Yueqing People's Hospital
Yueqing, Zhejiang
Daliuta Experimental District People's Hospital of Shenmu City
Yulin, Shanxi
Zhangzhou Municipal Hospital
Zhangzhou, Fujian
Henan Provincial People's Hospital
Zhengzhou, Henan
Zhongxiang Traditional Chinese Medical Hospital
Zhongxiang, Wuhan
Xihua County People's Hospital
Zhoukou, Henan
Yiyuan Country People's Hospital
Zibo, Shandong
Zibo Central Hospital
Zibo, Shandong
About this study
Official title: 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)
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.
Read the detailed description
The study population are patients with acute anterior circulation large vessel occlusion stroke and planned to undergo endovascular treatment. All participants are randomly assigned in a 1:1 ratio to the tocilizumab group or the placebo group. In tocilizumab group, participants will receive tocilizumab combined endovascular treatment. And in placebo group, participants will receive placebo combined endovascular treatment. All participants will be visited immediately postoperatively, at 24 hours, 7 days, and 90 days after randomization.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Tocilizumab, Placebo
- Keywords
- Stroke, Interleukin-6 Receptor Inhibitor, Endovascular Treatment
- Medical subject headings
- Ischemic Stroke, 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 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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab group | Experimental | Endovascular treatment combined 240 mg tocilizumab injection once. Receives: Drug: Tocilizumab |
| Placebo group | Placebo comparator | Endovascular treatment combined equivalent volume of placebo once. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale (mRS) score at 90 days
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Measured: 90 days
Secondary outcomes (10)
Proportion of patients with mRS score 0-2 at 90 days
Measured: 90 days and 1year
Proportion of patients with mRS score 0-1 at 90 days
Measured: 90 days and 1year
National Institutes of Health Stroke Scale (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 or at early discharge
Infarct volume at 24 hours
Measured: 24 hours
EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) at 90 days
The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities,pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scoresindicating worse quality of life.
Measured: 90 days and 1year
Proportion of Barthel Index (BI) 95-100 at 90 days
Measured: 90 days and 1year
Incidence of symptomatic intracerebral hemorrhage within 24 hours
Measured: 24 hours
Incidence of any intracerebral hemorrhage within 24 hours
Measured: 24 hours
Proportion of patients with pneumonia at 7 days or at early discharge
Measured: 7 days or at early discharge
Mortality at 90 days
Measured: 90 days and 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start5 Dec 2025
- Primary completion18 Sep 2026
- Study completion11 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- 692 participants (actual)
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
- NCT07263776
- Sponsor's protocol ID
- IRIS-2
- Acronym
- IRIS-2
- Status last verified
- Sep 2026
- First submitted
- 23 Nov 2025
- Last updated
- 6 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 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 Anterior Circulation Large Vessel Occlusion Stroke: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial-2 (IRIS-2)
- ClinicalTrials.gov ID
- NCT07263776
- Acronym / sponsor ID
- IRIS-2 / IRIS-2
- Conditions
- Acute Ischemic Stroke
- Keywords
- Stroke, Interleukin-6 Receptor Inhibitor, Endovascular Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 692 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 18 Sep 2026 (actual)
- Study completion
- 11 Jun 2027 (estimated)
- First posted
- 4 Dec 2025 (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 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.
Detailed description
The study population are patients with acute anterior circulation large vessel occlusion stroke and planned to undergo endovascular treatment. All participants are randomly assigned in a 1:1 ratio to the tocilizumab group or the placebo group. In tocilizumab group, participants will receive tocilizumab combined endovascular treatment. And in placebo group, participants will receive placebo combined endovascular treatment. All participants will be visited immediately postoperatively, at 24 hours, 7 days, and 90 days after randomization.
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 group | Experimental | Drug: TocilizumabEndovascular treatment combined 240 mg tocilizumab injection once. |
| Placebo group | Placebo comparator | Drug: PlaceboEndovascular treatment combined equivalent volume of placebo once. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (19 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 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. | Drug | Tocilizumab group |
| PlaceboAn 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. | Drug | Placebo group |
Primary outcome
modified Rankin Scale (mRS) score at 90 days
Time frame: 90 days
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
10 secondary outcomes
Proportion of patients with mRS score 0-2 at 90 days
Time frame: 90 days and 1year
Proportion of patients with mRS score 0-1 at 90 days
Time frame: 90 days and 1year
National Institutes of Health Stroke Scale (NIHSS) score at 7 days or at early discharge
Time frame: 7 days or at early discharge
Infarct volume at 24 hours
Time frame: 24 hours
EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) at 90 days
Time frame: 90 days and 1year
Proportion of Barthel Index (BI) 95-100 at 90 days
Time frame: 90 days and 1year
Incidence of symptomatic intracerebral hemorrhage within 24 hours
Time frame: 24 hours
Incidence of any intracerebral hemorrhage within 24 hours
Time frame: 24 hours
Proportion of patients with pneumonia at 7 days or at early discharge
Time frame: 7 days or at early discharge
Mortality at 90 days
Time frame: 90 days and 1year
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 6 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
54 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 Acute Ischemic Stroke, run by Capital Medical University at 54 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 6 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (mRS) score 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 6 Oct 2026.