A Phase 3 interventional study of Tocilizumab and NaCl 0.9% 100ml in Brain Diseases, Ischemic Stroke and Ischemia, sponsored by Zhujiang Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by Zhujiang Hospital · Phase 3, Interventional, and Treatment
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.
Intracranial atherosclerosis (ICAS) is one of the most common causes of stroke worldwide, and the currently recommended intensive pharmacologic and surgical treatments show only modest efficacy, with approximately 20% of strokes still recurring, for which there is no targeted treatment. Tocilizumab is a recombinant humanized anti-human interleukin-6 receptor monoclonal antibody that exerts anti-inflammatory effects by specifically binding to the IL-6 receptor and blocking IL-6 signal transduction. Previous studies have shown that tocilizumab can effectively attenuate acute ischemic injury in the early stage of myocardial infarction and has potentially anti-atherosclerotic effects. However, application in ICAS not yet reported. This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial, which enrolled patients with symptomatic ICAS occurring within 72 hours of ischemic stroke or high-risk transient ischemic attack. Patients who consented to participate in the study were randomly assigned in a 1:1 ratio to receive a single infusion of 320mg tocilizumab or placebo (saline injection), and patients were followed up to assess the safety and efficacy of tocilizumab injection in lowering the incidence of newly diagnosis ischemic stroke and improving prognosis.
502 studies on the registry are indexed under Brain Diseases; 141 are open to participants now.
This study's planned enrollment of 486 is above the median of 66 across 339 interventional studies indexed under Brain Diseases.
Browse Brain Diseases studies →Zhujiang Hospital is the lead sponsor of 202 studies on the registry; 96 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenously for more than 1 hour.
Drug: Tocilizumab
Intravenously for more than 1 hour.
Drug: NaCl 0.9% 100ml
Single dose intravenous application
Single dose intravenous application
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.
Time frame: 90(±7) days
The functional neurological status at 6(±1) days or discharge if earlier from baseline
The functional neurological status is evaluated through National Institute of Health Stroke Scale(NIHSS). The NIHSS is a standardized neurological examination score that is a valid and reliable measure of disability and recovery after acute stroke. Scores range from 0 to 42, with higher scores indicating more severe disability. The scale includes measures of level of consciousness, extra ocular movements, motor and sensory tests, coordination, language and speech evaluations.
Time frame: 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
IS is defined as an acute episode of a new focal neurological deficit lasting \>24 hrs, an increase in existing focal neurological deficit lasting \>24 hrs, or a focal neurological deficit lasting \<24 hrs that is associated with evidence of new ischemic changes based on neuroimaging. The focal neurological deficit is unrelated to a non-ischemic etiology. Hemorrhage may be a result of IS. Hemorrhagic stroke including SAH and ICH is defined as a new focal neurological deficit caused by a nontraumatic intraparenchymal hemorrhage, with neuroimaging evidence of corresponding intraparenchymal hemorrhage, except hemorrhagic transformation of an IS. MI is defined as an episode of myocardial necrosis in a clinical setting consistent with myocardial ischemia. TIA is defined as a transient episode of a focal ischemic neurological deficit resolving completely within 24 hrs, caused by focal cerebral or retinal ischemia, without evidence of corresponding cerebral infarction based on neuroimaging.
Time frame: 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
IS is defined as an acute episode of a new focal neurological deficit lasting \>24 hrs, an increase in existing focal neurological deficit lasting \>24 hrs, or a focal neurological deficit lasting \<24 hrs that is associated with evidence of new ischemic changes based on neuroimaging. The focal neurological deficit is unrelated to a non-ischemic etiology. Hemorrhage may be a result of IS. Hemorrhagic stroke including SAH and ICH is defined as a new focal neurological deficit caused by a nontraumatic intraparenchymal hemorrhage, with neuroimaging evidence of corresponding intraparenchymal hemorrhage, except hemorrhagic transformation of an IS. MI is defined as an episode of myocardial necrosis in a clinical setting consistent with myocardial ischemia. TIA is defined as a transient episode of a focal ischemic neurological deficit resolving completely within 24 hrs, caused by focal cerebral or retinal ischemia, without evidence of corresponding cerebral infarction based on neuroimaging.
Time frame: 90(±7) days
Proportion of patients with functional independence at 90(±7) days
Functional independence is defined as the modified Rankin Scale(mRS) score ranging from 0-2. The mRS is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 to 6, with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death.
Time frame: 90(±7) days
Health-related quality of life at 90(±7) days
Health-related quality of life is assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L). The EQ-5D-5L is a generic instrument for describing and valuing health. It is based on a descriptive system that defines health in terms of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five response categories corresponding to: no problems, slight, moderate, severe and extreme problems. The instrument is designed for self-completion, and respondents also rate their overall health on the day of the interview on a 0-100 hash-marked, vertical visual analogue scale.
Time frame: 90(±7) days
Mortality at 90(±7) days
Mortality rates are defined as the number of deaths observed divided by the number of subjects observed over the 90-day study period.
Time frame: 90(±7) days
Incidence of serious adverse events
Including but not limited to acute respiratory failure, severe or malignant cerebral artery infarction, acute heart failure, debridement decompression, and other major medical events that can result in death, immediately life-threatening, hospitalization or prolongation of this hospitalization, terminally or severely disabling/incapacitating, the loss of a significant ability to maintain normal life functioning, or medical intervention to avoid the above outcomes.
Time frame: 90(±7) days
Change of inflammatory blood biomarkers from admission to 72 hours
Interleukin-6 (IL-6)
Time frame: 72 hours
Change of inflammatory blood biomarkers from admission to 72 hours
hypersensitive C-reactive protein (hsCRP)
Time frame: 72 hours
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tocilizumab