Interleukin-6 Receptor Inhibition for Symptomatic Intracranial Atherosclerosis

Sponsor
Zhujiang Hospital
Study ID
NCT06447701
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Atheroscleroses, Intracranial
  • Atherosclerosis of Artery
  • Brain Diseases
  • Cerebral Infarction
  • Ischemia
  • Ischemic Stroke
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Single dose intravenous application
  • NaCl 0.9% 100ml — DRUG
    Single dose intravenous application

Study Details

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.

Key Dates

Start date
Oct 30, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2025
Completion
Jun 30, 2029

Study Design

Enrollment
486 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab group
    Intravenously for more than 1 hour.
  • Placebo Comparator: Control group
    Intravenously for more than 1 hour.

Primary Outcome Measure

The proportion of patients with newly diagnosed ischemic stroke within 90(±7) days [ Time Frame: 90(±7) days ]

Related Studies