Tocilizumab for Acute ischemic stroke|Ischaemic stroke

Inclusion criteria

• {"criterion_text":"- Participant must be above 18 years of age at the time of signing the informed consent.\n- Participants who have acute ischemic stroke selected for emergency endovascular treatment according to treatment guidelines.\n- Onset of stroke symptoms (last-known-well) time to randomization time within 12 hours.\n- 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).\n- Women of childbearing potential (WOCBP) can only be included if they use a highly effective contraception method as defined in Appendix 4 of the protocol.\n- Capable of giving signed informed consent or given by legal representative as described in Appendix I, section 10.1.2., including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol."}

Exclusion criteria

• {"criterion_text":"- Any intracranial haemorrhage during the qualifying imaging.\n- Known prior receipt of tocilizumab for any reason, including prior enrolment in this trial.\n- Contraindications to MRI.\n- Absent or poor collateral circulation during qualifying imaging.\n- Known thrombocytopenia (platelet count <100 × 10³/µL), neutropenia, or elevated liver enzymes (ALT or AST >1.5 × the upper limit of normal [ULN]).\n- Large core of established infarction (ASPECTS 0-2).\n- Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg at baseline, despite appropriate medical management.\n- 5.\tKnown hypersensitivity to tocilizumab or any of the excipients listed in section 6.1 of the SmPC: Sucrose, Polysorbate 80 (E 433), Disodium phosphate dodecahydrate (for pH adjustment), Sodium dihydrogen phosphate dihydrate (for pH adjustment) and water for injections.\n- Pregnancy/Lactation; female, with positive urine or serum beta human chorionic gonadotropin (β-hCG) test, or breastfeeding.\n- Malignancies, ongoing infection, immunodeficiency, or any suspicion of acute infection.\n- Clinical history, past imaging or clinical judgment suggesting that the intracranial occlusion is chronic, or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.\n- Endovascular thrombectomy procedure is completed as defined by the presence of TICI 2c/3 reperfusion or completion of groin / arterial closure\n- Patients receiving immunosuppressive drugs other than prednisolone ≤ 10 mg/day."}

Primary endpoints

• {"endpoint_text":"- ΔDWI lesion volume","definition_or_measurement_approach":"Change in diffusion-weighted imaging (DWI) lesion volume measured on MRI; primary objective assesses infarct growth at 72 hours after endovascular thrombectomy (EVT) using DWI MRI."}

Secondary endpoints

• {"endpoint_text":"- DWI lesion volume\n- ΔFLAIR lesion volume\n- FLAIR lesion volume\n- Change in levels of brain derived (BD)-Tau\n- Change in levels of high-sensitivity C-reactive protein (hsCRP)\n- NIHSS\n- mRS score\n- EQ-5D-5L domains and VAS\n- Occurrence of death (all-cause and stroke-related)\n- Occurrence of symptomatic intracranial haemorrhage\n- Occurrence of any intracranial haemorrhage\n- Occurrence of any infection\n- Occurrence of pneumonia\n- Occurrence of serious adverse events\n- Occurrence of adverse events\n- Blood levels of circulating surrogate markers\n- Blood levels of immune activation -and inflammatory markers\n- Alterations in immune cell transcriptomics and genomic alterations in relation to primary and secondary endpoints.\n- Serum concentrations of tocilizumab\n- Worsening of index stroke defined as (A) progression of infarct core, or haemorrhagic transformation of the index stroke, as documented by medical imaging that is (a) life-threatening requiring intervention and/or (b) results in increased disability as gauged by a ≥4-point increase from lowest NIHSS during hospitalization or (B) results in death from the index stroke.\n- Occurence of NIHSS score 0-2\n- Sex difference in infarct growth, NIHSS, mRS, EQ-5D-5L domains and VAS\n- Mean MCA peak systolic velocity ratio\n- Median NIHSS\n- Median mRS\n- Rate of mortality\n- Mean score on EQ-5D-5L domains and VAS\n- Atrophy, infarct volume at MRI\n- Blood levels of immune activation and inflammatory markers\n- Rate of major cardiovascular events (MACE)","definition_or_measurement_approach":"Where specified in the protocol: many endpoints are measured at baseline and post-EVT with timepoints including 72 hours (imaging endpoints: DWI/FLAIR lesion volumes, infarct growth), discharge, 30 days and 90 days (NIHSS, mRS, EQ-5D-5L), and baseline-to-post-EVT changes for biomarkers (BD-Tau, hsCRP). Occurrence endpoints specify time windows where stated (e.g. symptomatic intracranial haemorrhage until 72 hours; infections until discharge). Additional analyses include serum tocilizumab concentrations, transcriptomics/genomics in relation to endpoints, and long-term outcomes (including 5-year follow-up as specified in objectives)."}

Norway

Earliest CTIS Part Ii Submission Date

09-03-2026

Latest Decision Or Authorization Date

12-03-2026

Processing Time Days

3

Number Of Sites

2

Number Of Participants

156

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway