A Phase 2/3 interventional study of Tociliuzumab and Placebo in Acute Ischemic Stroke, sponsored by Oslo University Hospital. Not yet recruiting at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Oslo University Hospital · Phase 2/3, Interventional, and Treatment
The goal of this phase II, placebo-controlled intervention study is to investigate whether tocilizumab, an interleukin-6 (IL-6) receptor inhibitor, may have a neuroprotective effect by reducing infarct growth in adults with acute ischemic stroke.
The main question it aims to answer is:
Does treatment with tocilizumab given before or during endovascular therapy (EVT) reduce infarct growth 72 hours after EVT compared with placebo in adults with acute ischemic stroke?
Researchers will compare tocilizumab with placebo to determine whether infarct growth is smaller in participants receiving tocilizumab.
Participants will:
Receive either a single dose of tocilizumab or placebo before or during EVT. Undergo standard endovascular treatment for acute ischemic stroke. Undergo brain MRI approximately 72 hours after EVT to assess infarct growth. Have clinical assessments and other study-related examinations and follow-up according to the study protocol.
Acute ischemic stroke is a major cause of death and long-term disability. Although endovascular therapy (EVT) can effectively restore blood flow in patients with large-vessel occlusion, brain tissue injury may continue to develop after reperfusion. Infarct growth after successful reperfusion is associated with worse functional outcomes and may be influenced by inflammatory processes triggered by ischemia and reperfusion.
Interleukin-6 (IL-6) is an important mediator of the inflammatory response following acute ischemic stroke. Tocilizumab is a monoclonal antibody that blocks the IL-6 receptor and is an established treatment for several inflammatory conditions. Experimental and clinical evidence suggests that modulation of the IL-6 pathway may reduce inflammation and tissue injury following ischemic stroke.
The Illuminate study is a phase II, randomized, double-blind, placebo-controlled clinical trial designed to investigate whether early treatment with tocilizumab can reduce infarct growth in adults with acute ischemic stroke undergoing EVT. Participants will be randomly assigned to receive a single intravenous dose of tocilizumab or matching placebo before or during EVT, in addition to standard stroke treatment.
The primary objective is to determine whether treatment with tocilizumab reduces infarct growth assessed by brain magnetic resonance imaging (MRI) approximately 72 hours after EVT, compared with placebo. Secondary and exploratory assessments will evaluate clinical outcomes, imaging findings, safety, and biological markers of inflammation.
The study will provide clinical data on whether early inhibition of the IL-6 pathway may limit brain tissue injury after reperfusion and inform the design of future clinical trials of anti-inflammatory treatment in acute ischemic stroke.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's planned enrollment of 156 is above the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Oslo University Hospital is the lead sponsor of 830 studies on the registry; 146 are open to participants now.
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Participants are eligible to be included in the study only if all of the following criteria apply:
Age
Participant must be above 18 years of age at the time of signing the informed consent.
Type of Participant and Disease Characteristics
Large vessel occlusion in the anterior circulation (terminal internal carotid artery, M1 or M2 segment of MCA). Tandem extracranial carotid and intracranial occlusions are permitted.
Sex and Contraceptive/Barrier Requirements
Women of childbearing potential (WOCBP) can only be included if they use a highly effective contraception method as defined in Appendix 3 of the protocol.
Informed Consent
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
Known prior receipt of tocilizumab for any reason, including prior enrolment in this trial.
Diagnostic Assessments
Participants randomized to this arm will receive a single intravenous dose of matching placebo in addition to standard endovascular therapy (EVT) for acute ischemic stroke. Placebo will be administered before or during EVT, according to the study protocol.
Drug: Placebo
Participants randomized to this arm will receive a single intravenous dose of tocilizumab in addition to standard endovascular therapy (EVT) for acute ischemic stroke. Tocilizumab will be administered before or during EVT, according to the study protocol.
Drug: Tociliuzumab
Participants randomized to this arm will receive a single intravenous dose of tocilizumab in addition to standard endovascular therapy (EVT) for acute ischemic stroke. Tocilizumab will be administered before or during EVT, according to the study protocol.
Also known as: RoActemra
Participants randomized to this arm will receive a single intravenous dose of matching placebo in addition to standard endovascular therapy (EVT) for acute ischemic stroke. Placebo will be administered before or during EVT, according to the study protocol.
Infarct growth on brain MRI (mL)
Infarct growth is defined as the change in DWI lesion volume from baseline to 72 hours after completion of EVT. DWI lesion volume will be measured on brain MRI at baseline and 72 hours after completion of EVT. Infarct growth will be calculated as the DWI lesion volume at 72 hours minus the baseline DWI lesion volume.
Time frame: Within 8 hours after completion of EVT and at 72 hours after completion of EVT
Infarct volume on brain MRI at 72 hours after EVT (mL)
DWI lesion volume measured on brain MRI at 72 hours after completion of EVT.
Time frame: At 72 hours after completion of EVT
Change in FLAIR lesion volume from baseline to 72 hours after EVT
Change in FLAIR lesion volume from the first post-EVT brain MRI to the brain MRI at 72 hours after EVT. The first post-EVT MRI will be performed within 8 hours after completion of EVT. Change in FLAIR lesion volume will be calculated as lesion volume at 72 hours minus lesion volume on the first post-EVT MRI.
Time frame: Within 8 hours after completion of EVT and at 72 hours after completion of EVT
Effect of tocilizumab given before/during EVT on FLAIR lesion volume at 72 hours after EVT in patients with acute ischemic stroke
FLAIR lesion volume measured on brain MRI at 72 hours after completion of EVT
Time frame: At 72 hours after completion of EVT
Change in high-sensitivity C-reactive protein (hsCRP) levels
Change in high-sensitivity C-reactive protein (hsCRP) levels from baseline to 72 hours and 90 days after completion of EVT
Time frame: At baseline, 72 hours, and 90 days after completion of EVT
National Institutes of Health Stroke Scale (NIHSS) score
National Institute of Health Stroke Scale (NIHSS) score, min 0, max 42
Time frame: At 24 hours, 72 hours, hospital discharge, and 90 days after completion of EVT
Modified Rankin Scale (mRS) score
Modified Rankin Scale (mRS) score measured at hospital discharge, 30 days, 90 days, and 12 months after completion of EVT. mRS range 0-6.
Time frame: At hospital discharge, 30 days, 90 days, and 12 months after completion of EVT
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale (EQ VAS) score (0-100)
The EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ VAS) records the participant's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: At 90 days and 12 months after completion of EVT
All-cause mortality
Occurrence of death (all-cause and stroke-related)
Time frame: At hospital discharge, 30 days, and 90 days after completion of EVT
Symptomatic intracranial haemorrhage
Occurrence of symptomatic intracranial haemorrhage during the first 72 hours after completion of EVT
Time frame: Through 72 hours after completion of EVT
Any intracranial haemorrhage
Occurrence of any intracranial haemorrhage during the first 72 hours after completion of EVT
Time frame: At 72 hours after completion of EVT
Any infection
Occurrence of any infection during hospitalization, based on clinical assessment, blood samples, and relevant investigations for infection
Time frame: At hospital discharge upto 6 weeks
Stroke-associated pneumonia
Occurrence of stroke-associated pneumonia during hospitalization, based on clinical assessment and relevant diagnostic investigations
Time frame: At hospital discharge upto 6 weeks
Serious adverse events
Occurrence of serious adverse events from completion of EVT through 90 days after completion of EVT.
Time frame: Through 90 days after completion of EVT
Adverse events
Occurrence of adverse events from completion of EVT through 30 days after completion of EVT.
Time frame: Through 30 days after completion of EVT
Plan to share: Undecided — Pending
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Tocilizumab