Actively Recruiting
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-755 in Acute Ischemic Stroke
Led by Takeda · Updated on 2026-04-20
222
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Acute ischemic stroke (AIS) occurs when blood flow to part of the brain suddenly stops due to a blood clot blocking a vessel, causing serious health problems and affecting quality of life. This trial aims to evaluate the safety and tolerability of TAK-755 in adults with AIS, as well as its potential to help manage daily activities and reduce stroke symptom severity compared to a placebo. The study is a Phase 2, randomized, double-blind, placebo-controlled trial sponsored by Takeda. Participants will receive a single intravenous infusion of either TAK-755 or a placebo on Day 1 in two parts of the study. Following treatment, all participants will be monitored for up to 90 days while continuing their usual AIS care according to hospital practice. The trial includes careful administration and observation periods for safety and efficacy assessment. During the study, participants will undergo evaluations including monitoring for symptomatic intracranial hemorrhage within 120 hours, assessments of adverse events, vital signs, laboratory tests, and antibody presence. Stroke severity and recovery will be measured using scales like the Modified Rankin Scale and National Institutes of Health Stroke Scale at various time points up to 90 days post-treatment. The trial design includes detailed follow-up to assess safety, tolerability, and stroke outcomes.
CONDITIONS
Brief Title
A Study of TAK-755 in Adults With Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legally authorized representative has provided informed consent before any trial procedures.
- Age between 18 and 80 years at the time of consent.
- Clinical diagnosis of acute ischemic stroke.
- Stroke symptoms started within 24 hours of enrollment; wake-up strokes included if last known well is within 24 hours.
- National Institutes of Health Stroke Scale score between 6 and 25 indicating moderate to severe stroke.
- Modified Rankin Scale score less than 2 prior to stroke indicating no significant disability.
- Signs and symptoms consistent with anterior circulation stroke.
- Imaging shows causative acute ischemic stroke occlusion in specific brain arteries.
- Imaging shows evidence of salvageable brain tissue on CT or MRI.
You will not qualify if you...
- Weight over 130 kg or under 40 kg.
- History of severe traumatic brain injury within past 90 days.
- History of intracranial hemorrhage or intracranial neoplasm except small meningioma.
- Stroke within the past 90 days or intracranial/intraspinal surgery within past 90 days.
- Major surgery or severe trauma within past 14 days.
- History of cerebral amyloid angiopathy or systemic malignancy except certain skin cancers.
- Serious illness with life expectancy less than 1 year.
- Participation in other interventional trials within 90 days.
- Known life-threatening allergy to TAK-755 or previous TAK-755 use.
- Recent administration of caplacizumab or von Willebrand factor-containing products.
- Inability to understand the trial, prior administration of certain clot-busting drugs for current stroke.
- Eligibility for intravenous thrombolysis or intent to undergo endovascular thrombectomy for current stroke.
- Seizure at stroke onset or persistent high blood pressure before randomization.
- Blood glucose under 50 mg/dL or over 400 mg/dL.
- Active uncontrolled bleeding or bleeding disorders.
- Inability to undergo MRI or CT.
- Rapidly improving stroke symptoms or chronic intracranial occlusion.
- Occlusion of extracranial internal carotid artery or evidence of infection-related emboli.
- Other significant diseases posing risk, pregnancy, lactation, or inability to comply with birth control.
- Poor quality imaging or evidence of significant brain swelling or multiple vascular occlusions.
- Evidence of brain hemorrhage, tumors, aneurysm, or vascular malformations.
- Low platelet count below 50,000/mm3.
- Potential inability or unwillingness to cooperate with trial procedures.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 120 hours
Participants receive a single intravenous (IV) infusion of TAK-755 or placebo on Day 1.
1 visit (in-person)
Duration - Up to 90 days post treatment
Participants are followed for safety and efficacy assessments after treatment.
Approximately 1 to 2 visits
Trial Site Locations
Total: 1 location
1
Honor Health
Scottsdale, Arizona, United States, 85251
Actively Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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