Trials / Not Yet Recruiting
Not Yet RecruitingNCT06447701
Interleukin-6 Receptor Inhibition for Symptomatic Intracranial Atherosclerosis
Effect of Interleukin-6 Receptor Inhibition for Avoiding Recurrence of Ischemic Stroke in Patients With Symptomatic Intracranial Atherosclerosis: a Double-blind, Randomized, Placebo-controlled Trial
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 486 (estimated)
- Sponsor
- Zhujiang Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Brain Diseases
- Ischemic Stroke
- Ischemia
- Stroke
- Cerebral Infarction
- Atherosclerosis of Artery
- Atheroscleroses, Intracranial
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tocilizumab | Single dose intravenous application |
| DRUG | NaCl 0.9% 100ml | Single dose intravenous application |
Timeline
- Start date
- 2025-10-30
- Primary completion
- 2025-12-31
- Completion
- 2029-06-30
- First posted
- 2024-06-07
- Last updated
- 2025-07-28
Source: ClinicalTrials.gov record NCT06447701. Inclusion in this directory is not an endorsement.