Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Posterior Circulation Large Vessel Occlusion Stroke (IRIS-3)

April 29, 2026 updated by: Ji Xunming,MD,PhD, Capital Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
348

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100053
        • Recruiting
        • Capital Medical Univercity Xuanwu Hospital
    • Anhui
      • Suzhou, Anhui, China, 234000
        • Recruiting
        • Suzhou Municipal hospital
        • Contact:
          • Zhengfei Ma
    • Henan
      • Anyang, Henan, China, 455000
        • Recruiting
        • Anyang People's Hospital
        • Contact:
          • Jiangang Zhang
      • Nanyang, Henan, China, 473000
        • Recruiting
        • Nanyang Central Hospital
        • Contact:
          • Yifeng Liu
      • Xinxiang, Henan, China, 453000
        • Recruiting
        • The First Affiliated Hospital of Henan Medical University
        • Contact:
          • Hongkai Cui
      • Zhoukou, Henan, China, 466600
        • Recruiting
        • People's Hospital of Xihua
        • Contact:
          • Chaoqun Li
    • Shandong
      • Linyi, Shandong, China, 276000
        • Recruiting
        • People's Hospital of Linyi
        • Contact:
          • Hao Wang
      • Zibo, Shandong, China, 255000
        • Recruiting
        • Zibo central Hospital
        • Contact:
          • Liangjie Wang
    • Shanxi
      • Xianyang, Shanxi, China, 712000
        • Recruiting
        • Xianyang First People's Hospital
        • Contact:
          • Xingyun Yuan
      • Yuncheng, Shanxi, China, 044000
        • Recruiting
        • Yuncheng Central Hospital
        • Contact:
          • Bin Wang
    • Zhejiang
      • Lishui, Zhejiang, China, 323000
        • Recruiting
        • Lishui Central Hospital
        • Contact:
          • Xiao Peng
      • Taizhou, Zhejiang, China, 318000
        • Recruiting
        • Taizhou enze Hospital
        • Contact:
          • Shaoqing Jiang
      • Yueqing, Zhejiang, China, 325600
        • Recruiting
        • People's Hospital of Yueqing
        • Contact:
          • Saizhen Wu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 years or older, of either sex;
  2. Acute ischemic stroke caused by occlusion of the basilar artery;
  3. Decide to undergo emergency endovascular treatment;
  4. Time from stroke onset to groin puncture within 24 hours;
  5. National Institutes of Health Stroke Scale (NIHSS) ≥ 10;
  6. Posterior circulation Alberta Stroke Program Early computed tomography score (pc-ASPECTS) ≥ 6;
  7. Signed informed consent from the patients or the legally authorized representatives.

Exclusion Criteria:

  1. Intracerebral hemorrhage, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage;
  2. Pre-stroke modified Rankin scale (mRS) score >1;
  3. Known allergy to tocilizumab or excipients;
  4. Known allergy to iodinated contrast agents;
  5. Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
  6. History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, or thrombocytopenic diseases;
  7. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg despite blood pressure control;
  8. Neutrophils < 2 × 10^9 /L;
  9. Platelets < 100 × 10^9 /L;
  10. Blood glucose <2.8 mmol/L (50 mg/dL) or >22.2 mmol/L (400 mg/dL);
  11. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2 times the upper limit of normal;
  12. Known recent or current serum creatinine >2 times the upper limit of normal or estimated glomerular filtration rate (eGFR) <60 mL/min;
  13. Pregnant, lactating, or planning pregnancy within 90 days;
  14. Severe mental disorders or inability to comply with informed consent and follow-up requirements due to dementia;
  15. Concurrent malignant tumors or severe systemic diseases with expected survival of less than 90 days;
  16. Presence of autoimmune diseases or use of immunosuppressive drugs;
  17. Systemic infectious diseases;
  18. Participation in another interventional clinical study within 30 days before randomization or currently participating in another interventional clinical study;
  19. Any circumstance that, as assessed by the investigators, might result in harm to the patients if study therapy is initiated;
  20. Other conditions that the investigator considers might affect compliance or preclude participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tocilizumab
Endovascular treatment combined with a 240mg tocilizumab injection once
Drug: Tocilizumab
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.
Placebo Comparator: Placebo
Endovascular treatment combined with placebo
Drug: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Barthel Index (BI) 95-100 at 90 days
Time Frame: 90 days
90 days
mRS score distribution at 90 days;
Time Frame: 90 days
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
90 days
Early neurological improvement at 24 hours
Time Frame: 24 hours
Defined as a reduction in NIHSS score of at least 8 points from baseline or a score of 0 to 2
24 hours
NIHSS score at 7 days or at early discharge
Time Frame: 7 days
The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes
7 days
Proportion of patients with mRS score 0-1 at 90 days
Time Frame: 90 days
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
90 days
Proportion of patients with mRS score 0-2 at 90 days
Time Frame: 90 days
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
90 days
Proportion of patients with mRS score 0-4 at 90 days
Time Frame: 90 days
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
90 days
EQ-5D-5L at 90 days
Time Frame: 90 days
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.
90 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Mortality at 90 days
Time Frame: 90 days
90 days
Incidence of symptomatic intracranial hemorrhage within 24 hours
Time Frame: 24 hours
24 hours
Incidence of any intracranial hemorrhage within 24 hours
Time Frame: 24 hours
24 hours
Proportion of patients with pneumonia at 7 days or at early discharge
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRIS-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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