Acute Ischemic StrokePhase 2/3IlluminateNCT07870681
Infarct Growth After Intravenous Tocilizumab in Adults With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy - ILLUMINATE
A Phase 2/3 study testing Tociliuzumab in people with Acute Ischemic Stroke, run by Oslo University Hospital at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Tociliuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 21 Sep 2026to 31 Jan 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Participants who have acute ischemic stroke selected for emergency endovascular treatment according to treatment guidelines.
- Onset of stroke symptoms (last-known-well) time to randomization time within 12 hours.
Show all 11Show fewer
- 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
- 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.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Medical Conditions
- Any intracranial haemorrhage during the qualifying imaging.
- Malignancies, immunodeficiency, ongoing infection or any suspicion of acute infection.
- 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.
- Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg at baseline, despite appropriate medical management.
Show all 15Show fewer
- 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]).
- 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
- Endovascular thrombectomy procedure is completed as defined by the presence of TICI 2c/3 reperfusion or completion of groin / arterial closure.
- Patients receiving immunosuppressive drugs other than prednisolone ≤ 10 mg/day. Prior/Concurrent Clinical Study Experience
- Known prior receipt of tocilizumab for any reason, including prior enrolment in this trial.
- Diagnostic Assessments
- Contraindications to MRI.
- Large core of established infarction (ASPECTS 0-2). Other Exclusion Criteria
- Pregnancy/Lactation; female, with positive urine or serum beta human chorionic gonadotropin (β-hCG) test, or breastfeeding.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Denmark4 sites
Aalborg University Hospital
Aalborg
Boris Modrau, MD PhD, +4551159170, boris.modrau@rn.dk
Aarhus University Hospital
Aarhus
Rolf Blauenfeldt, MD PhD, +45 78 45 00 00, rolfblau@rm.dk
Rigshospitalet
Copenhagen
Thomas C Truelsen, MD PhD, +4521810068, thomas.clement.truelsen@regionh.dk
Rikke Puggaard, MD, +45 35 45 35 45, rikke.puggaard@regionh.dk
Odense University Hospital
Odense
Karen L Ægidius, MD PhD, +4560891960, Karen.Lehrmann.AEgidius@rsyd.dk
Norway2 sites
Akershus University Hospital
Lørenskog
Marianne Altmann, MD PhD, +4792253294, marianne.altmann@ahus.no
Oslo University Hospital
Oslo, 0424
Anne Hege Aamodt, MD PhD, 95867270, a.h.aamodt@medisin.uio.no
Lars Hansen Tveit, MD, +4792203202, latvei@ous-hf.no
About this study
Official title: A Randomized Placebo-controlled Double-blind Trial Phase II Two-arm Study to Investigate Infarct Growth Over 72 Hours Assessed With Diffusion Weighted Imaging on MRI After Treatment With Intravenous Tocilizumab or Placebo in Patients Above 18 Years of Age With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy.
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Tociliuzumab, Placebo
- Keywords
- neuroprotection, endovascular therapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TociliuzumabDrug
Also called RoActemra
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| Tocilizumab | Active comparator | 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. Receives: Drug: Tociliuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 8 hours after completion of EVT and at 72 hours after completion of EVT
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: At 90 days and 12 months after completion of EVT
All-cause mortality
Occurrence of death (all-cause and stroke-related)
Measured: 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
Measured: Through 72 hours after completion of EVT
Any intracranial haemorrhage
Occurrence of any intracranial haemorrhage during the first 72 hours after completion of EVT
Measured: 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
Measured: At hospital discharge upto 6 weeks
Stroke-associated pneumonia
Occurrence of stroke-associated pneumonia during hospitalization, based on clinical assessment and relevant diagnostic investigations
Measured: 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.
Measured: Through 90 days after completion of EVT
Adverse events
Occurrence of adverse events from completion of EVT through 30 days after completion of EVT.
Measured: Through 30 days after completion of EVT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start21 Sep 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, placebo-controlled, parallel-group interventional study. Participants will be randomly assigned to receive either tocilizumab or matching placebo in addition to standard endovascular therapy (EVT) for acute ischemic stroke. Study treatment will be administered before or during EVT. Participants, investigators, treating clinicians, outcome assessors, and other study personnel will remain blinded to treatment allocation, except where unblinding is required for participant safety.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, University Hospital, Akershus, Aarhus University Hospital, Aalborg University Hospital, Odense University Hospital
- Responsible party
- Principal investigator, Anne Hege Aamodt, Oslo University Hospital
- Investigators
- Anne Hege Aamodt, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870681
- Sponsor's protocol ID
- EU CT no 2025-521269-28-00
- Acronym
- Illuminate
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pending
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-controlled Double-blind Trial Phase II Two-arm Study to Investigate Infarct Growth Over 72 Hours Assessed With Diffusion Weighted Imaging on MRI After Treatment With Intravenous Tocilizumab or Placebo in Patients Above 18 Years of Age With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy.
- ClinicalTrials.gov ID
- NCT07870681
- Acronym / sponsor ID
- Illuminate / EU CT no 2025-521269-28-00
- Conditions
- Acute Ischemic Stroke
- Keywords
- neuroprotection, endovascular therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, University Hospital, Akershus, Aarhus University Hospital, Aalborg University Hospital, Odense University Hospital
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, placebo-controlled, parallel-group interventional study. Participants will be randomly assigned to receive either tocilizumab or matching placebo in addition to standard endovascular therapy (EVT) for acute ischemic stroke. Study treatment will be administered before or during EVT. Participants, investigators, treating clinicians, outcome assessors, and other study personnel will remain blinded to treatment allocation, except where unblinding is required for participant safety.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
| Tocilizumab | Active comparator | Drug: TociliuzumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- Participants who have acute ischemic stroke selected for emergency endovascular treatment according to treatment guidelines.
Key exclusion criteria (15 listed)
- Medical Conditions
- Any intracranial haemorrhage during the qualifying imaging.
- Malignancies, immunodeficiency, ongoing infection or any suspicion of acute infection.
- 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.
- Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg at baseline, despite appropriate medical management.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TociliuzumabAlso: RoActemraParticipants 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 | Tocilizumab |
| PlaceboParticipants 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 |
Primary outcome
Infarct growth on brain MRI (mL)
Time frame: 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.
14 secondary outcomes
Infarct volume on brain MRI at 72 hours after EVT (mL)
Time frame: At 72 hours after completion of EVT
Change in FLAIR lesion volume from baseline to 72 hours after EVT
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
Time frame: At 72 hours after completion of EVT
Change in high-sensitivity C-reactive protein (hsCRP) levels
Time frame: At baseline, 72 hours, and 90 days after completion of EVT
National Institutes of Health Stroke Scale (NIHSS) score
Time frame: At 24 hours, 72 hours, hospital discharge, and 90 days after completion of EVT
Modified Rankin Scale (mRS) score
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)
Time frame: At 90 days and 12 months after completion of EVT
All-cause mortality
Time frame: At hospital discharge, 30 days, and 90 days after completion of EVT
Symptomatic intracranial haemorrhage
Time frame: Through 72 hours after completion of EVT
Any intracranial haemorrhage
Time frame: At 72 hours after completion of EVT
Any infection
Time frame: At hospital discharge upto 6 weeks
Stroke-associated pneumonia
Time frame: At hospital discharge upto 6 weeks
Serious adverse events
Time frame: Through 90 days after completion of EVT
Adverse events
Time frame: Through 30 days after completion of EVT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided. Pending
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Hege Aamodt study chair
Oslo University Hospital
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tociliuzumab in people with Acute Ischemic Stroke, run by Oslo University Hospital at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Hege Aamodt, MD, PhD (+47 95867270, a.h.aamodt@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct growth on brain MRI (mL) (time frame: Within 8 hours after completion of EVT and at 72 hours after completion of EVT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.