Interleukin-6 Receptor Inhibition for Symptomatic Intracranial Atherosclerosis

NCT06447701 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: LC2024ZD025
• Study Type: interventional
• Target: 486
• Locations: 0 countries
• Sites: N/A

Brief Summary

IRIS-sICAS is a multicenter, randomized, double-blind, placebo-controlled clinical trialis a multicenter, randomized, double-blind, placebo-controlled clinical trial, to assess the safety and efficacy of tocilizumab injection in lowering the incidence of newly diagnosis ischemic stroke and improving prognosis in symptomatic intracranial atherosclerosis patients.

Conditions

Brain Diseases; Ischemic Stroke; Ischemia; Stroke; Cerebral Infarction; Atherosclerosis of Artery; Atheroscleroses, Intracranial

Keywords

Tocilizumab; Symptomatic intracranial atherosclerotic stenosis; Recurrence; Ischemic stroke

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with newly diagnosed ischemic stroke within 90(±7) days

  Stroke is defined as an acute episode of focal neurological dysfunction associated with cerebral vascular injury, with no apparent non-vascular cause such as brain infection, trauma, tumor, seizure, severe metabolic disease, or degenerative neurological disease. Ischemic stroke is defined as an acute episode of a new focal neurological deficit lasting \>24 hours, an increase in existing focal neurological deficit lasting \>24 hours, or a focal neurological deficit lasting \<24 hours that is associated with evidence of new ischemic changes based on neuroimaging. The focal neurological deficit is not attributable to a non-ischemic etiology. Hemorrhage may be a consequence of ischemic stroke, and in this situation, the stroke is an ischemic stroke with hemorrhagic transformation but not a hemorrhagic stroke.

  90(±7) days

Secondary Outcomes (9)

• The functional neurological status at 6(±1) days or discharge if earlier from baseline

  6(±1) days

• The incidence of composite events including any type of stroke (ischemic stroke(IS), subarachnoid hemorrhage(SAH), or intracerebral hemorrhage(ICH)), myocardial infarction(MI), and transient ischemic attack(TIA) and each of foresaid events at 30(±3) days

  30(±3) days

• The incidence of composite events including any type of stroke (ischemic stroke(IS), subarachnoid hemorrhage(SAH), or intracerebral hemorrhage(ICH)), myocardial infarction(MI), and transient ischemic attack(TIA) and each of foresaid events at 90(±7) days

  90(±7) days

• Proportion of patients with functional independence at 90(±7) days

  90(±7) days

• Health-related quality of life at 90(±7) days

  90(±7) days

Study Arms (2)

Tocilizumab group

EXPERIMENTAL

Intravenously for more than 1 hour.

Drug: Tocilizumab

Control group

PLACEBO COMPARATOR

Intravenously for more than 1 hour.

Drug: NaCl 0.9% 100ml

Interventions

Tocilizumab DRUG

Single dose intravenous application

Tocilizumab group

NaCl 0.9% 100ml DRUG

Single dose intravenous application

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant women with acute stroke symptoms aged over 18 years.
• Patients having an ischemic stroke or a TIA prior to randomization (Patients having an acute ischemic stroke within 72 hours with NIHSS score≤5 at baseline, or patients having a TIA within 72 hours with Oxfordshire Community Stroke Project on the basis of age, blood pressure, clinical features, and duration of TIA symptoms (ABCD2) score≥4 at baseline).
• The entry event is attributed to symptomatic atherosclerosis (50-99%) in an intracranial qualifying artery (intracranial carotid artery (C4-7), middle cerebral artery (M1), intracranial vertebral artery or basilar artery) confirmed by CT, MR angiography, or digital subtraction angiography.
• Informed consent obtained from patients or their legal representatives.
• Willing to be followed up as required by the clinical study protocol.

You may not qualify if:

• Thrombolytic therapy or thrombectomy within 24 hours prior to enrollment.
• Pre-stroke mRS score ≥ 2.
• Combined or previous intracranial hemorrhage: hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.
• Any of the following unequivocal cardiac source of embolism: chronic or paroxysmal atrial fibrillation, sinus node dysfunction, mitral stenosis, prosthetic heart valves, endocarditis, left ventricular mural thrombus or valvular vegetation, myocardial infarction within three months, dilated cardiomyopathy, spontaneous echogenic defects in the left atrium or an ejection fraction of less than 30%.
• Intracranial arterial stenosis due to arterial dissection, Moya Moya disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; post-partum angiopathy; suspected vasospastic process, suspected recanalized embolus; any known vasculitic disease.
• Extracranial stenosis ≥50%, subclavian arterial stenosis≥50% or subclavian steal syndrome.
• Previous interventions for intracranial arterial stenosis.
• Concurrent intracranial tumors, intracranial aneurysms or arteriovenous malformations
• Neutrophil \< 2×10 9/L.
• Platelet \< 100×10 9/L.
• Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal.
• Active infections including localized.
• Evidence of HIV or hepatitis B positivity.
• Positive tuberculosis-related tests.
• Concurrent peptic ulcer, diverticulitis or inflammatory bowel disease.

Sponsors & Collaborators

• Zhujiang Hospital: lead
• Shenzhen Second People's Hospital: collaborator
• Central People's Hospital of Zhanjiang: collaborator
• Shantou Central Hospital: collaborator
• Eighth Affiliated Hospital, Sun Yat-sen University: collaborator
• Guangzhou First People's Hospital: collaborator
• Peking University Shenzhen Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator

MeSH Terms

Conditions

Brain Diseases; Ischemic Stroke; Ischemia; Stroke; Cerebral Infarction; Intracranial Arteriosclerosis; Recurrence

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subject numbers and corresponding medication numbers are permanently identified and unique for each successfully randomized patient. If any patients who have been successfully randomized do not receive the trial medication or cannot be reassigned to others, their medication and medication numbers will be invalidated by the medication administrator. To ensure blinding during the trial execution, unblinded personnel responsible for administering and configuring the trial drug must sign a confidentiality agreement.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The subject numbers and corresponding medication numbers are permanently identified and unique for each successfully randomized patient. If any patients who have been successfully randomized do not receive the trial medication or cannot be reassigned to others, their medication and medication numbers will be invalidated by the medication administrator. To ensure blinding during the trial execution, unblinded personnel responsible for administering and configuring the trial drug must sign a confidentiality agreement. Investigators, other blinded investigators, subjects, and sponsors will not have access to any information regarding group assignment or related documents pertaining to the trial drug.

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: October 30, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share