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TAK-755 Safety and Tolerability in Acute Ischemic Stroke

Study Aim

This phase 2 study aims to evaluate the safety and tolerability of TAK-755 in individuals who have experienced an acute ischemic stroke, specifically by measuring the percentage of participants who develop symptomatic intracranial hemorrhage as defined by the Heidelberg Bleeding Classification System.

What is being tested

TAK-755

+ Placebo

BiologicalOther

Who is being recruted

Ischemic Stroke+5

+ Brain Diseases

+ Cardiovascular Diseases

From 18 to 80 Years

+48 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: April 2026

See protocol details

Summary

Principal SponsorTakeda

Study ContactTakeda Contact

Last updated: February 7, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 15, 2026

Actual date on which the first participant was enrolled.

Acute ischemic stroke (AIS) is a serious condition caused by a sudden halt in blood flow to a part of the brain, often due to a blood clot. This can lead to severe health issues, and even death, impacting the quality of life. The urgency lies in restoring blood flow to the brain as quickly as possible to minimize long-term damage. This study focuses on an adult population suffering from AIS, aiming to evaluate the safety and tolerability of a drug called TAK-755. The potential benefits of TAK-755 include helping stroke patients manage daily activities and reducing the severity of stroke symptoms. In this study, participants receive either a single dose of TAK-755 or a placebo, which looks like TAK-755 but contains no medicine. This is to ensure participants are unaware of their assigned treatment. Regardless of the assigned group, all participants receive standard AIS treatment as per hospital practice. Their health is then monitored for approximately 3 months. The primary outcome measured is the percentage of participants who develop symptomatic intracranial hemorrhage (sICH), a complication that can occur after a stroke. The Heidelberg Bleeding Classification System, a structured 7-step approach that combines imaging results with clinical deterioration, is used to determine if an intracranial hemorrhage is symptomatic.

Official TitleA Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-755 in Acute Ischemic Stroke

NCT07392450

Principal SponsorTakeda

Study ContactTakeda Contact

Last updated: February 7, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

222 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ischemic StrokeBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesVascular DiseasesStroke

Criteria

9 inclusion criteria required to participate

Clinical diagnosis of AIS.

The participant or legally authorized representative has provided informed consent before the initiation of any trial procedures.

18 to 80 years of age, inclusive, at the time of signing the informed consent form.

Onset of stroke symptoms within 24 hours of enrollment. Wake-up strokes may be included if Last Known Well is within 24 hours of enrollment; time of onset will be considered the time of Last Known Well.

Show More Criteria

39 exclusion criteria prevent from participating

Evidence of extensive early ischemic change estimated to be greater than one-third of the middle cerebral artery territory.

Evidence of intracranial tumor (except incidental, small meningioma), cerebral aneurysm, or arteriovenous malformation.

Platelet count <50,000/ cubic millimeters (mm^3).

Rapidly improving AIS symptoms.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Participants will receive a single intravenous (IV) infusion of TAK-755 on Day 1 of Part A. All participants will be followed for up to 90 days post treatment.

Group II

Experimental

Participants will receive a single IV infusion of TAK-755 on Day 1 of Part B. All participants will be followed for up to 90 days post treatment.

Group III

Placebo

Participants will receive a single IV infusion of TAK-755 matching placebo on Day 1 of Parts A and B. All participants will be followed for up to 90 days post treatment.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

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