A Study of TAK-755 in Adults With Acute Ischemic Stroke

August 13, 2026 updated by: Takeda

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

Acute ischemic stroke (AIS) is a medical emergency that happens because of a sudden stop of blood flow to a part of the brain. This happens when a blood clot forms within the vessel (known as thrombotic occlusion) or a clot originating from somewhere else blocks a blood vessel (known as embolic occlusion). Strokes can cause serious health problems, death, and affect one's quality of life. To reduce long-term damage, it is important to restore blood flow to the brain as soon as possible.

The main aim of this study is to check how safe TAK-755 is, and how well adults with AIS tolerate it. Other aims are to check how well TAK-755 helps participants to manage their everyday activities and to understand whether it helps reduce the seriousness of their stroke symptoms when compared to placebo. A placebo looks like TAK-755, but does not have any medicine in it, to make sure participants do not know which treatment they are taking.

The participants will receive TAK-755 or placebo once; afterwards, their health will be monitored for about 3 months (90 days). All participants, regardless of their assignment to either TAK-755 or placebo, will receive the usual treatment for AIS as per the hospital's normal practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
222

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Not yet recruiting
        • Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
        • Principal Investigator:
          • Julien Ly
        • Contact:
      • Liège, Belgium, 4000
        • Not yet recruiting
        • Groupe sante CHC - Clinique du MontLegia
        • Principal Investigator:
          • Philippe Desfontaines
        • Contact:
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Not yet recruiting
        • Ziekenhuis Oost-Limburg
        • Contact:
        • Principal Investigator:
          • Sam Van Boxstael
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Not yet recruiting
        • Universitair Ziekenhuis Gent (Belgium,Ghent)
        • Principal Investigator:
          • Dimitri Hemelsoet
        • Contact:
    • WVL
      • Kortrijk, WVL, Belgium, 8500
        • Not yet recruiting
        • AZ Groeninge
        • Principal Investigator:
          • Peter Vanacker
        • Contact:
  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
        • Recruiting
        • Hospital Moinhos de Vento
        • Contact:
        • Principal Investigator:
          • Leonardo Augusto Carbonera
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Not yet recruiting
        • Porto Alegre Clinical Hospital (HCPA)
        • Principal Investigator:
          • Sheila Cristina Ouriques Martins
        • Contact:
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-687
        • Not yet recruiting
        • Universidade Estadual Paulista Julio de Mesquita Filho Faculdade de Medicina Campus de Botucatu
        • Principal Investigator:
          • Rodrigo Bazan
        • Contact:
      • Campinas, São Paulo, Brazil, 13083-888
        • Not yet recruiting
        • Universidade Estadual de Campinas (UNICAMP)
        • Contact:
        • Principal Investigator:
          • Wagner Mauad Avelar
      • Ribeirão Preto, São Paulo, Brazil, 14048-900
        • Not yet recruiting
        • Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - Universidade de Sao Paulo
        • Contact:
        • Principal Investigator:
          • Octavio Marques Pontes-Neto
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Not yet recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto
        • Contact:
        • Principal Investigator:
          • Mariana Neves Marques Battaglini
      • São Paulo, São Paulo, Brazil, 04022-001
        • Not yet recruiting
        • Hospital Sao Paulo / Escola Paulista de Medicina da Universidade Federal de Sao Paulo (EPM/UNIFESP)
        • Contact:
        • Principal Investigator:
          • Gisele Sampaio Silva
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital, Capital Medical University
        • Principal Investigator:
          • Yongjun Wang
        • Contact:
    • Henan
      • Nanyang, Henan, China, 473003
        • Recruiting
        • Nanshi Hospital of Nanyang
        • Contact:
        • Principal Investigator:
          • Xiaohua Xiao
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Principal Investigator:
          • Yanbo Cheng
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Principal Investigator:
          • Wei Wu
        • Contact:
      • Liaocheng, Shandong, China, 252000
        • Recruiting
        • Liaocheng People's Hospital
        • Contact:
        • Principal Investigator:
          • Dong Guo
      • Linyi, Shandong, China, 276000
        • Recruiting
        • Linyi People's Hospital
        • Principal Investigator:
          • Ziran Wang
        • Contact:
    • Shanxi
      • Datong, Shanxi, China, 037000
        • Recruiting
        • Sinopharm Tongmei General Hospital
        • Principal Investigator:
          • Junhai Wang
        • Contact:
      • Linfen, Shanxi, China, 041099
        • Recruiting
        • Linfen Central Hospital
        • Principal Investigator:
          • Hongguo Dai
        • Contact:
  • France
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Not yet recruiting
        • CHU Bordeaux, CHU Pellegrin
        • Principal Investigator:
          • Igor Sibon
        • Contact:
    • IDF
      • Garches, IDF, France, 92380
        • Not yet recruiting
        • Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Raymond-Poincare
        • Contact:
        • Principal Investigator:
          • Sandrine Deltour Bouard
      • Le Kremlin-Bicêtre, IDF, France, 94270
        • Not yet recruiting
        • Bicetre Hospital
        • Contact:
        • Principal Investigator:
          • Christian Denier
      • Paris, IDF, France, 75018
        • Not yet recruiting
        • Groupe Hospitalier Bichat Claude Bernard
        • Contact:
        • Principal Investigator:
          • Elena Meseguer
      • Paris, IDF, France, 78600
        • Not yet recruiting
        • Hôpital Lariboisière
        • Principal Investigator:
          • Mikael Mazighi
        • Contact:
  • Germany
      • Berlin, Germany, 12203
        • Not yet recruiting
        • Charité Universitätsmedizin Berlin
        • Contact:
        • Principal Investigator:
          • Jan Scheitz
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Not yet recruiting
        • Universitaetsklinikum Heidelberg (UKHD)
        • Principal Investigator:
          • Jan Purrucker
        • Contact:
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Not yet recruiting
        • Universitaetsklinikum Tuebingen
        • Principal Investigator:
          • Annerose Mengel
        • Contact:
    • Brandenburg
      • Potsdam, Brandenburg, Germany, 14467
        • Not yet recruiting
        • Klinikum Ernst von Bergmann
        • Contact:
        • Principal Investigator:
          • Andrea Rocco
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Not yet recruiting
        • Goethe-Universitaet-Universitaetsmedizin Frankfurt-Zentrum der Neurologie und Neurochirurgie (ZNN)
        • Contact:
        • Principal Investigator:
          • Jan Hendrick Schaefer
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • Not yet recruiting
        • Universitaetsmedizin Goettingen
        • Contact:
        • Principal Investigator:
          • Ilko Maier
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Not yet recruiting
        • Technische Universitaet Dresden-Universitaetsklinikum Carl Gustav Carus
        • Contact:
        • Principal Investigator:
          • Martin Arndt
  • Greece
      • Athens, Greece, 11521
        • Not yet recruiting
        • Athens Navy Hospital
        • Contact:
        • Principal Investigator:
          • Michail Ioakeimidis
      • Thessaloniki, Greece, 54636
        • Not yet recruiting
        • AHEPA University General Hospital of Thessaloniki
        • Contact:
        • Principal Investigator:
          • Theodoros Karapanayiotides
    • Attica
      • Chaïdári, Attica, Greece, 12462
        • Not yet recruiting
        • Second Department of Neurology, National and Kapodistrian University of Athens, "Attikon" University Hospital
        • Principal Investigator:
          • Georgios Tsivgoulis
        • Contact:
    • Evros
      • Alexandroupoli, Evros, Greece, 68100
        • Not yet recruiting
        • University Hospital of Alexandroupolis
        • Contact:
        • Principal Investigator:
          • Konstantinos Vadikolias
  • India
      • New Delhi, India, 110029
        • Not yet recruiting
        • All India Institute of Medical Sciences, New Delhi, Department of Neurology
        • Contact:
        • Principal Investigator:
          • Ayush Agarwal
    • Karnataka
      • Belagavi, Karnataka, India, 590010
        • Not yet recruiting
        • AES - AS - KLES Dr Prabhakar Kore Hospital and Medical Research Centre
        • Contact:
        • Principal Investigator:
          • Aralikatte Saroja
    • Kerala
      • Kochi, Kerala, India, 682041
        • Not yet recruiting
        • Amrita Institute of Medical Sciences and Research Centre
        • Contact:
        • Principal Investigator:
          • Vivek Nambiar
    • Punjab
      • Ludhiana, Punjab, India, 141008
        • Not yet recruiting
        • Christian Medical College, Ludhianana
        • Contact:
        • Principal Investigator:
          • Ivy Anne Sebastian
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • Not yet recruiting
        • Bangur Institute of Neurosciences
        • Contact:
        • Principal Investigator:
          • Biman Kanti Ray
  • Japan
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 810-0001
        • Recruiting
        • Saiseikai Fukuoka General Hospital
        • Contact:
        • Principal Investigator:
          • Kazutaka Sonoda
      • Fukuoka, Fukuoka, Japan, 811-0213
    • Nagano
      • Nagano, Nagano, Japan, 381-8551
    • Osaka
      • Izumisano, Osaka, Japan, 598-8577
        • Not yet recruiting
        • Rinku General Medical Center
        • Contact:
        • Principal Investigator:
          • Yasushi Hagihara
      • Osaka, Osaka, Japan, 556-0017
        • Not yet recruiting
        • Kotobukikai Tominaga Hospital
        • Contact:
        • Principal Investigator:
          • Ko Matsuda
  • United Kingdom
      • London, United Kingdom, W2 1NY
        • Not yet recruiting
        • Imperial College Healthcare NHS Trust, St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Dheeraj Kalladka
    • Aberdeen
      • Cornhill, Aberdeen, United Kingdom, AB25 2ZD
        • Not yet recruiting
        • Aberdeen Royal Infirmary
        • Contact:
        • Principal Investigator:
          • Mary Macleod
    • Bedfordshire
      • Luton, Bedfordshire, United Kingdom, LU4 0DZ
        • Not yet recruiting
        • Bedfordshire Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Sekaran Lakshmanan
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G4 0SF
        • Not yet recruiting
        • University of Glasgow - PPDS
        • Contact:
        • Principal Investigator:
          • Terence Quinn
      • Glasgow, Lanarkshire, United Kingdom, G51 4TF
        • Not yet recruiting
        • NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital
        • Contact:
        • Principal Investigator:
          • Amith Sitaram
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
      • Tucson, Arizona, United States, 85724
        • Not yet recruiting
        • University of Arizona
        • Contact:
        • Principal Investigator:
          • Firas Kaddouh
    • California
      • San Francisco, California, United States, 94143
        • Not yet recruiting
        • University of California San Francisco
        • Contact:
        • Principal Investigator:
          • Anthony Kim
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • W. Taylor Kimberly
    • New York
      • Buffalo, New York, United States, 14202
        • Not yet recruiting
        • University at Buffalo
        • Principal Investigator:
          • Marilou Ching
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Not yet recruiting
        • University of Pittsburgh Medical Center
        • Contact:
        • Principal Investigator:
          • Nirav Bhatt
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Not yet recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Michael Froehler
        • Contact:
    • Texas
      • Cypress, Texas, United States, 77429
        • Not yet recruiting
        • HCA Houston Healthcare - North Cypress
        • Contact:
        • Principal Investigator:
          • Sushrut Dharmadhikari
      • Dallas, Texas, United States, 75243
        • Not yet recruiting
        • Neurology Consultants of Dallas, PA
        • Contact:
        • Principal Investigator:
          • Ryan Cheung

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Informed Consent:

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

    Age:

  2. greater than and equal to (>=) 18 years of age, inclusive, at the time of signing the Informed Consent Form (ICF) or confirmation of deferred consent eligibility.

    Clinical Characteristics:

  3. Clinical diagnosis of AIS.
  4. Onset of stroke symptoms within 24 hours of randomization. Wake-up strokes may be included if Last Known Well is within 24 hours of randomization; time of onset will be considered the time of Last Known Well.

  5. National Institutes of Health Stroke Scale score of 5 to 25, indicating moderate to severe stroke. Participants with an NIHSS score of 5 are eligible only if at least 1 predefined disabling neurological deficit is present, as defined by one or more of the following

    NIHSS criteria:

    • Complete hemianopia (NIHSS visual score >=2).
    • Aphasia impairing meaningful communication (NIHSS language score >=2).
    • Motor deficit with inability to sustain effort against gravity (NIHSS left or right motor arm or leg score >=2).
  6. Estimated Modified Rankin Scale score less than (<) 2 prior to AIS presentation, signifying no significant disability.

  7. Persistent neurological signs and symptoms consistent with unilateral supratentorial circulation stroke.

    Imaging:

  8. Evidence of causative AIS occlusions affecting supratentorial circulation on imaging (intracranial internal carotid artery [ICA], middle cerebral artery [MCA; M1 - M4], anterior cerebral artery [ACA; A1 - A3], posterior cerebral artery [PCA; P1 - P3]).
  9. Evidence of salvageable brain tissue on CT or MR imaging.

Exclusion Criteria:

Medical History:

  1. Weight >130 kilograms (kg) or <40 kg.
  2. History of severe traumatic brain injury in the past 90 days.
  3. History of intracranial hemorrhage.
  4. History of intracranial neoplasm except for small meningioma.
  5. History of prior stroke in the past 90 days.
  6. History of intracranial or intraspinal surgery within the past 90 days.
  7. Major surgery or severe trauma in the past 14 days.
  8. History of cerebral amyloid angiopathy.
  9. Recent history of active systemic malignancy within the last 5 years, except for locally excised basal cell or squamous cell skin carcinoma with clear margins.
  10. Diagnosis of serious, advanced, or terminal illness with anticipated life expectancy of less than 1 year.
  11. Participation in other interventional clinical trials within the previous 90 days.
  12. Known life-threatening hypersensitivity reaction to TAK-755 or its components.
  13. Any prior administration of TAK-755.
  14. Administration of caplacizumab in the past 30 days.
  15. Administration of von Willebrand factor-containing products in the past 14 days.

  16. Baseline conditions (prior to the index AIS event) that prevent an understanding of the nature, scope, and possible consequences of the trial, in the judgment of the investigator.

    Current Stroke Management:

  17. Any prior administration (intravenous or intra-arterial) of alteplase or tenecteplase for the index AIS event, as well as any prior administration of prourokinase or reteplase for the index AIS event in countries where approved.
  18. Eligible for administration of intravenous thrombolysis (alteplase or tenecteplase, as well as prourokinase or reteplase in countries where approved) for the index AIS event, based on the site's standard clinical guidelines and direct availability.
  19. Intent to proceed with endovascular thrombectomy (EVT) for the index AIS event based on eligibility and direct availability.
  20. Seizure at time of index AIS event onset, only if it precludes accurate assessment of baseline NIHSS.
  21. Persistent blood pressure elevation (systolic >=185 millimeters of mercury [mmHg] or diastolic >=110 mm Hg) prior to randomization.

  22. Blood glucose <50 milligrams per deciliter (mg/dL) or >400 mg/dL.

    Current Medical Conditions:

  23. Active, uncontrolled bleeding.
  24. Bleeding diathesis or any other conditions that would pose significant bleeding risk.
  25. Inability to undergo MRI or CT.
  26. Chronic causative intracranial occlusion.
  27. Causative total occlusion of the extracranial ICA.
  28. Evidence of septic emboli or bacterial endocarditis.
  29. Another clinically significant concomitant disease that may pose additional risks for the participant in the opinion of the investigator.

  30. Pregnancy, lactation, or unable to comply with birth control methods or abstinence as specified in the protocol in the opinion of the investigator.

    Imaging:

  31. Poor quality imaging that precludes interpretation according to trial protocol.
  32. Evidence of significant intracranial mass effect or midline shift.
  33. Evidence of acute occlusion in >1 vascular territory (right/left MCA, right/left ACA, right/left PCA); multiple occlusions within the same vascular territory are allowed.
  34. Evidence of acute or chronic intracranial hemorrhage (presence of chronic cerebral microbleeds on magnetic resonance imaging [MRI]) T2*-weighted type sequence (such as gradient recalled echo [GRE] or susceptibility weighted imaging [SWI]) is not exclusionary if total <10 and not consistent with diagnosis of cerebral amyloid angiopathy).
  35. Evidence of extensive early ischemic change estimated to be greater than one-third of the middle cerebral artery territory or evidence of well-demarcated hypoattenuation on computed tomography (CT), if performed, consistent with established infarction and judged by the investigator to correspond to the clinical symptoms of the index AIS.

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

    Laboratory:

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

    Other:

  38. Identification by the investigator as being potentially unable or unwilling to cooperate with trial procedures.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A: TAK-755
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.
Biological: TAK-755
TAK-755 IV infusion.
Other Names:
  • rADAMTS13
Experimental: Part B: TAK-755
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.
Biological: TAK-755
TAK-755 IV infusion.
Other Names:
  • rADAMTS13
Placebo Comparator: Part A and B: 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.
Other: Placebo
TAK-755 matching placebo IV infusion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part A and B: Percentage of Participants who Develop Symptomatic Intracranial Hemorrhage (sICH) as Defined by the Heidelberg Bleeding Classification System
Time Frame: Up to 120 hours of study drug administration
The Heidelberg Bleeding Classification System is used to determine whether an Intracranial Hemorrhage (ICH) is symptomatic (sICH) or asymptomatic (aICH). It uses a structured 7-step approach that integrates imaging findings with clinical deterioration. This algorithm includes anatomic description of hemorrhage, adjudication of neurological deterioration, and relatedness between ICH and clinical deterioration. Percentage of participants who develop sICH will be reported.
Up to 120 hours of study drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part A: Percentage of Participants With Treatment-Related and Unrelated Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: From start of study drug administration up to follow-up (up to 90 days)
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a trial intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the trial intervention or medicinal product. An SAE is defined as any untoward medical occurrence that results in death or is life-threatening or requires inpatient hospitalization or results in significant disability/incapacity or is a congenital anomaly or meets the definitions of other medically significant events. Percentage of participants with TEAEs and SAEs will be reported.
From start of study drug administration up to follow-up (up to 90 days)
Part A: Percentage of Participants With Severe TEAEs
Time Frame: From start of study drug administration up to follow-up (up to 90 days)
A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a trial intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the trial intervention or medicinal product. A severe TEAE is a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Percentage of participants with severe TEAEs will be reported.
From start of study drug administration up to follow-up (up to 90 days)
Part A: Percentage of Participants With Life-Threatening Adverse Events (AEs)
Time Frame: From start of study drug administration up to follow-up (up to 90 days)
Percentage of participants with life-threatening AEs will be reported.
From start of study drug administration up to follow-up (up to 90 days)
Part A: Percentage of Participants With All-cause Mortality
Time Frame: From start of study drug administration up to follow-up (up to 90 days)
Percentage of participants who died during the entire study period will be reported.
From start of study drug administration up to follow-up (up to 90 days)
Part A and B: Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-1
Time Frame: At Day 90
The mRS assessment will be used to grade the level of functional independence of participants following a stroke. It is a single-item, global outcome rating scale that categorizes functional independence based on pre-stroke activities, with seven grades representing no (0), no significant (1), slight (2), moderate (3), moderately severe (4), severe (5) disability and death (6). Lower scores indicate better functional outcome. Percentage of participants with mRS of 0-1 will be reported.
At Day 90
Part A and B: Percentage of Participants With mRS Score of 0-2
Time Frame: At Day 90
The mRS assessment will be used to grade the level of functional independence of participants following a stroke. It is a single-item, global outcome rating scale that categorizes functional independence based on pre-stroke activities, with seven grades representing no (0), no significant (1), slight (2), moderate (3), moderately severe (4), severe (5) disability and death (6). Lower scores indicate better functional outcome. Percentage of participants with mRS of 0-2 will be reported.
At Day 90
Part A and B: Ordinal Distribution of mRS at Day 90
Time Frame: At Day 90
The mRS assessment will be used to grade the level of functional independence of participants following a stroke. It is a single-item, global outcome rating scale that categorizes functional independence based on pre-stroke activities, with seven grades representing no (0), no significant (1), slight (2), moderate (3), moderately severe (4), severe (5) disability and death (6). Lower scores indicate better functional outcome.
At Day 90
Part A and B: Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) Score at 24 Hours
Time Frame: Baseline up to 24 hours
The NIHSS is a tool to objectively quantify the impairment caused by a stroke. NIHSS assessment is a 15-item impairment scale assessing level of consciousness, extraocular movements, visual fields, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria), and hemi-inattention (neglect). The total score ranges from 0 to 42 where higher scores indicate greater impairment. A negative change from Baseline indicates improvement.
Baseline up to 24 hours
Part A and B: Percentage of Participants With Recanalization According to Arterial Occlusive Lesion (AOL) Score of 3
Time Frame: At 24 Hours
The AOL scale score is a measure of recanalization and ranges from 0 to 3. The grading scale specifically measures the degree of recanalization at the defined target or causative occlusion. A score of 0 is defined as complete occlusion of the target artery. Scores of 1 and 2 account for partial recanalization, with a score of 1 indicating no distal flow while a score of 2 indicates any distal flow. A score of 3 is defined as complete recanalization with any distal flow. Percentage of participants with AOL Score of 3 will be reported.
At 24 Hours
Part A: Percentage of Participants With AEs of Special Interest (AESIs)
Time Frame: From start of study drug administration up to 168 hours
AESIs include sICH, treatment-related aICH, treatment-related extracranial bleeding SAEs, and recurrent AIS. Percentage of participants with AESIs will be reported.
From start of study drug administration up to 168 hours
Part A: Percentage of Participants With Clinically Relevant Changes in Vital Signs
Time Frame: From screening up to 90 days
Vital signs will include measurement of body temperature, respiratory rate, blood pressure and pulse rate. Any clinically relevant changes in vital signs will be determined at the investigator's discretion.
From screening up to 90 days
Part A: Percentage of Participants With Clinically Relevant Changes in Clinical Chemistry and Hematology
Time Frame: From screening up to 90 days
Laboratory parameters will include clinical chemistry and hematology. Any clinically relevant changes in laboratory values will be determined at the investigator's discretion.
From screening up to 90 days
Part A: Number of Participants With Treatment-induced Binding Antibodies to ADAMTS13
Time Frame: From Day 30 to Day 90
As per planned analysis, blood sample will be collected to monitor the development of binding antibodies to ADAMTS13.
From Day 30 to Day 90
Part A: Number of Participants With Treatment-induced Neutralizing Antibodies to ADAMTS13
Time Frame: From Day 30 to Day 90
As per planned analysis, blood sample will be collected to monitor the development of neutralizing antibodies to ADAMTS13.
From Day 30 to Day 90
Part A and B: Percentage of Participants With Reperfusion
Time Frame: At 24 Hours
Percentage of participants with reperfusion, defined as >90 percent (%) reduction from baseline in volume of tissue with time-to maximum (Tmax) >6 seconds on perfusion imaging will be reported.
At 24 Hours
Part A and B: Final Infarct Volume
Time Frame: At 72 hours or earlier at hospital discharge
Final infarct volume at 72 hours or hospital discharge (if earlier than 72 hours) will be reported.
At 72 hours or earlier at hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 6, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAK-755-2002
  • jRCT2071260013 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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