The goal of this clinical trial is to learn if AB126, an investigational treatment made from neural exosomes, is safe and well tolerated when given to adults with moderate to severe acute ischemic stroke (AIS) who have undergone endovascular thrombectomy (EVT) but have had limited neurological improvement after the procedure. The study will also evaluate different doses of AB126 to help determine the highest dose that can be given safely. The main questions it aims to answer are: 1. Is AB126 safe and well tolerated when given to participants with AIS following EVT? 2. What dose of AB126 can be given safely? 3. Does treatment with AB126 provide preliminary evidence of improved neurological recovery following stroke? Researchers will compare participants who receive AB126 with participants who receive placebo to evaluate the safety and tolerability of AB126 and to collect preliminary information about recovery following stroke. Participants will: 1. Be randomly assigned to receive either AB126 or placebo. Neither participants nor the study team will know which treatment is assigned. 2. Receive 3 intravenous (IV) doses of AB126 or placebo. The first dose will be given as soon as possible after EVT, but no later than 6 hours after blood flow has been restored. The second and third doses will be given approximately 24 and 48 hours after EVT. 3. Undergo medical examinations, laboratory tests, neurological assessments, and brain imaging during the study. 4. Remain under observation at a comprehensive stroke center until hospital discharge. 5. Complete follow-up assessments by telephone and in person for approximately 1 year after treatment, including assessments at approximately 10, 30, 90, 180, 270, and 360 days after treatment.
Male and female patients 18 to 85 years of age, inclusive.
Provision of written informed consent obtained from participant or an acceptable legally authorized representative.
Pre-stroke modified Rankin Scale score of 0 or 1.
Diagnosis of AIS due to large vessel occlusion in the anterior circulation, confirmed by neuroimaging (NCCT, CTA).
Known sensitivity to bovine serum albumin or other components likely to be present in AB126;
Posterior circulation stroke, including infarcts involving brainstem or cerebellum;
A pre-stroke modified Rankin Scale (mRS) score greater than 1
A history of prior stroke with persistent neurological deficits;
Parallel
AB126 Neural Exosomes Intravenous Injection
Biological/VaccineThree (3) intravenous injections of the active ingredient will be administered on Day 0, 1, and 2 after stroke.
AB126 Placebo
Other interventionAB126 Placebo, comprised of non-active ingredients, will be administered on Day 0, 1, and 2 after stroke.
Treatment-emergent adverse events
The primary objective of this study is to evaluate the safety and tolerability of escalating doses of AB126 in patients with moderate to severe AIS who have undergone EVT and demonstrate limited neurological improvement post-procedure. The primary safety study endpoints will be assessed through Day 90. These study endpoints will also be assessed through Day 360 or end of study.
Changes in physical and clinical examination findings
Rates of death
Recurrent stroke
Exploratory endpoint: Modified Rankin Scale (mRS)
Changes from baseline in Modified Rankin Scale (mRS) , including both the proportion of patients achieving mRS 0-2 and shift analysis across the full mRS scale
Exploratory endpoint: National Institute of Health Stroke Scale (NIHSS)
Changes from baseline in National Institute of Health Stroke Scale (NIHSS), including shift analysis across the full NIHSS
Exploratory endpoint: Montreal Cognitive Assessment scale (MoCA)
Changes over time in Montreal Cognitive Assessment scale (MoCA). MoCA score is a total out of 30 points, where a higher score indicates greater cognitive function.
Exploratory endpoint: Fugl-Meyer Upper Extremity Scale
Changes over time in Fugl-Meyer Upper Extremity Scale. This scale has a total possible score of 226 across five domains (motor function, sensory function, balance, joint range of motion, and joint pain) where a greater score indicates greater function.
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Aruna Bio, Inc.
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborator
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