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Starting soon Phase 2/3

Infarct Growth After Intravenous Tocilizumab in Adults With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy - ILLUMINATE

NCT07870681 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 2/3
Started
2026-09-21
Last updated
2026-10-13

Condition(s) studied

Acute Ischemic Stroke

Investigational drug(s) / intervention(s)

Tociliuzumab →Placebo

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.

Placebo: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: Age 1. Participant must be above 18 years of age at the time of signing the informed consent. Type of Participant and Disease Characteristics 2. Participants who have acute ischemic stroke selected for emergency endovascular treatment according to treatment guidelines. 3. Onset of stroke symptoms (last-known-well) time to randomization time within 12 hours. 4. 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 5. 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 6. Participants must be capable of giving signed informed consent or consent must be given by legal representative as described in Section 10.1.2., including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions 1. Any intracranial haemorrhage during the qualifying imaging. 2. Malignancies, immunodeficiency, ongoing infection or any suspicion of acute infection. 3. Clinical history, prior imaging or clinical judgment suggesting that the intracranial occlusion is chronic, or there is a suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention. 4. Systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg at baseline, despite appropriate medical management. 5. Known thrombocytopenia (platelet count \<100 × 10³/µL), neutropenia (neutrophil count \<2.5 × 10⁹/L), or elevated liver enzymes (ALT or AST \>1.5 × the upper limit of normal \[ULN\]). 6. Known 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. Prior/Concomitant Therapy 7. Endovascular thrombectomy procedure is completed as defined by the presence of TICI 2c/3 reperfusion or completion of groin / arterial closure. 8. Patients receiving immunosuppressive drugs other than prednisolone ≤ 10 mg/day. Prior/Concurrent Clinical Study Experience 9. Known prior receipt of tocilizumab for any reason, including prior enrolment in this trial. Diagnostic Assessments 10. Contraindications to MRI. 11. Large core of established infarction (ASPECTS 0-2). Other Exclusion Criteria 12. Pregnancy/Lactation; female, with positive urine or serum beta human chorionic gonadotropin (β-hCG) test, or breastfeeding.

Primary outcome measure(s)

  • Infarct growth on brain MRI (mL) — Within 8 hours after completion of EVT and at 72 hours after completion of EVT
    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.

Trial sites (6)

FacilityCityRegionStatus
Aalborg University Hospital Aalborg Denmark
Aarhus University Hospital Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Odense University Hospital Odense Denmark
Akershus University Hospital Lørenskog Norway
Oslo University Hospital Oslo Norway
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07870681 on ClinicalTrials.gov ↗ ← All trials in Denmark