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Interleukin-6Phase 2/3IRISNCT06238024

Effect of Interleukin-6 Receptor Inhibition in Patients With Ischemic Stroke Undergoing Endovascular Treatment

A Phase 2/3 study testing Tocilizumab and NaCl 0.9% 100ml in people with Interleukin-6 and Ischemic Stroke, run by Suzhou Municipal Hospital of Anhui Province at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Tocilizumab may exert neuroprotective effects in patients with ischemic stroke undergoing endovascular treatment Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Tocilizumab and NaCl 0.9% 100ml
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
1 siteChina
Study dates
2 Feb 2024to 22 Sep 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-80 years.
  • Acute ischemic stroke caused by occlusion of intracranial segment of the internal carotid artery, middle cerebral artery M1, or M2 segment.
  • NIHSS ≥ 6.
  • Meeting the criteria of endovascular treatment:
  • ① ASPECTS score ≥ 6, possibile to start endovascular treatment within 6 hours from stroke onset.
  • ② Stroke onset between 6-16 hours, meeting DEFUSE-3 criteria (infarct core volume < 70ml, mismatch ratio ≥ 1.8, and mismatch volume > 15ml), or DAWN criteria (NIHSS ≥ 10 and infarct core volume < 31ml; or NIHSS ≥ 20 and infarct volume 31-51ml).
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  • ③ Stroke onset between 16-24 hours, meeting DAWN criteria (NIHSS ≥ 10 and infarct core volume < 31ml; or NIHSS ≥ 20 and infarct volume 31-51ml).
  • ④ When ASPECTS score is < 6, meeting RESCUE-Japan LIMIT criteria (ASPECTS score 3-5; stroke onset within 6 hours or between 6-24 hours but no acute stroke signs on FLAIR), or ANGEL-ASPECT criteria (stroke onset within 24 hours, ASPECTS 3-5; or onset within 24 hours, ASPECTS 0-2 and infarct core volume 70-100 mL; or onset between 6-24 hours, ASPECTS > 5 and infarct core volume 70-100 mL), or SELECT2 criteria (ASPECTS 3-5; or infarct core volume greater than 50ml).
  • Experimental drug administration had to be possible within 24 hours after stroke onset.
  • Obtained Informed consent from the patient or their legal representative.

Who cannot join

  • Hemorrhagic diseases visible on head CT: hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.
  • Pre-stroke 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, thrombocytopenic diseases, etc.
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  • Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg despite blood pressure control.
  • Neutrophil < 2×10 9/L.
  • Platelet < 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 greater than 1.5 times the upper limit of normal.
  • Known recent or current serum creatinine exceeding 1.5 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 an 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Suzhou Municipal Hospital of Anhui Province

    Suzhou, Anhui

Other trials in China

About this study

Official title: Effect of Interleukin-6 Receptor Inhibition in Patients With Ischemic Stroke Undergoing Endovascular Treatment: a Double-blind, Randomized, Placebo-controlled Trial

Tocilizumab may exert neuroprotective effects in patients with ischemic stroke undergoing endovascular treatment

Read the detailed description

Vascular recanalization techniques, including thrombolysis and thrombectomy, have become the mainstay of treatment for acute ischemic stroke. However, some patients still experience poor prognosis, with ineffective recanalization and reperfusion brain injury being the major contributors to unfavorable outcomes. Studies have indicated that tocilizumab, used in ST-segment elevation and non-ST-segment elevation myocardial infarction, exhibits anti-inflammatory and myocardial protective effects. Nevertheless, whether tocilizumab can provide neuroprotection in the early stages of acute large vessel recanalization remains uncertain. Given the above evidence, the aim of this study was to investigate whether combination therapy with tocilizumab in the early phase of recanalization of acute large vessel occlusion could further exert a beneficial effect and thus improve the poor prognosis of patients.

Being tested
Tocilizumab, NaCl 0.9% 100ml
Keywords
Acute ischemic stroke, Tocilizumab, Neuroprotection, Outcome
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

    Single dose intravenous application

  • NaCl 0.9% 100mlDrug

    Single dose intravenous application

Study groups in NCT06238024
Study groupRoleWhat they receive
Tocilizumab groupExperimentalIntravenously for more than 1 hour.
Receives: Drug: Tocilizumab
Control groupPlacebo comparatorIntravenously for more than 1 hour.
Receives: Drug: NaCl 0.9% 100ml

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in infarct-core volume

    The infarct-core volume is determined by diffusion-weighted MRI, CT, or CTP images.

    Measured: 72 hours

Secondary outcomes (15)

  1. Early neurological improvement

    Decrease in National Institute of Health stroke scale (NIHSS) score of ≥8 or NIHSS score of 0-2 within 24 hours. NIHSS scores range from 0 to 42, with higher scores indicating greater neurologic deficit

    Measured: within 24 hours

  2. NIHSS score

    National Institutes of Health Stroke Scale (NIHSS) scores range from 0 to 42, with higher scores indicating greater neurologic deficit

    Measured: 24 hours

  3. Proportion of successful reperfusion (mTICI 2b/3)

    mTICI denotes modified Treatment in Cerebral Ischemia classification, with scores ranging from 0 (no flow) to 3 (normal flow)

    Measured: immediate postoperative

  4. Proportion of recanalization on follow-up CTA or MRA

    Measured: 72 hours

  5. Incidence of cerebral hemorrhage

    Measured: 72 hours

  6. Incidence of symptomatic cerebral hemorrhage

    Measured: 72 hours

  7. NIHSS score

    National Institutes of Health Stroke Scale (NIHSS) scores range from 0 to 42, with higher scores indicating greater neurologic deficit

    Measured: 7 days

  8. Incidence of stroke-associated pneumonia

    Measured: 7 days

  9. Incidence of decompressive craniectomy

    Measured: 7 days

  10. Proportion of patients with functional independence (mRS 0-2)

    Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability

    Measured: 90 days

  11. Shift analysis of mRS score

    Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability

    Measured: 90 days

  12. Barthel Index

    The Barthel index is an ordinal scale for measuring performance of activities of daily living. Scores ranges from 0 to 20, with 0 indicating severe disability and 19 or 20 indicating no disability that interferes with daily activities.

    Measured: 90 days

  13. EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D)

    EQ-5D is a standardized instrument for the measurement of health status. Scores range from -0.33 to 1.00, with higher scores indicating a better quality of life

    Measured: 90 days

  14. Death

    Measured: 90 days

  15. Adverse events and serious adverse events

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2024
  2. Study start2 Feb 2024
  3. Primary completion25 Jun 2024
  4. Study completion22 Sep 2024

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06238024
Sponsor's protocol ID
SZSLYY
Acronym
IRIS
Status last verified
Jul 2024
First submitted
15 Jan 2024
Last updated
25 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Chu X, Lan J, Ma Z, Yin Y, Gu H, Baron JC, Liesz A, Wen C, Liu Y, Sun J, Wang N, Li C, Feng X, Li J, Wang B, Feng Y, Wu C, Dong X, Zhou C, Li C, Zhao W, Liu G, Fisher M, Liebeskind DS, Fang M, Jia X, Ma H, Ji X, Wu C; IRIS investigators. Effect of IL-6 receptor inhibition on infarct volume after endovascular treatment for ischaemic stroke: a phase 2, randomised, placebo-controlled trial. EBioMedicine. 2026 Mar;125:106167. doi: 10.1016/j.ebiom.2026.106167. Epub 2026 Feb 12.

    PubMed 41687453

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Tocilizumab and NaCl 0.9% 100ml in people with Interleukin-6 and Ischemic Stroke, run by Suzhou Municipal Hospital of Anhui Province at 1 site 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 10 inclusion and 18 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: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline in infarct-core volume (time frame: 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06238024, which also lists 1 linked publication.

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 25 Sep 2024.

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