Acute Ischemic StrokePhase 2NCT07392450
A Study of TAK-755 in Adults With Acute Ischemic Stroke
A Phase 2 study testing TAK-755 in people with Acute Ischemic Stroke, run by Takeda at 60 sites in 10 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- TAK-755
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 60 sitesin 10 countries
- Study dates
- 17 May 2026to 6 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent:
- The participant or legally authorized representative has provided informed consent or deferred consent eligibility confirmed before the initiation of any trial procedures.
- Age:
- 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:
- Clinical diagnosis of AIS.
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- 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.
- 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).
- Estimated Modified Rankin Scale score less than (<) 2 prior to AIS presentation, signifying no significant disability.
- Persistent neurological signs and symptoms consistent with unilateral supratentorial circulation stroke.
- Imaging:
- 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]).
- Evidence of salvageable brain tissue on CT or MR imaging.
Who cannot join
- Medical History:
- Weight >130 kilograms (kg) or <40 kg.
- History of severe traumatic brain injury in the past 90 days.
- History of intracranial hemorrhage.
- History of intracranial neoplasm except for small meningioma.
- History of prior stroke in the past 90 days.
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- History of intracranial or intraspinal surgery within the past 90 days.
- Major surgery or severe trauma in the past 14 days.
- History of cerebral amyloid angiopathy.
- 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.
- Diagnosis of serious, advanced, or terminal illness with anticipated life expectancy of less than 1 year.
- Participation in other interventional clinical trials within the previous 90 days.
- Known life-threatening hypersensitivity reaction to TAK-755 or its components.
- Any prior administration of TAK-755.
- Administration of caplacizumab in the past 30 days.
- Administration of von Willebrand factor-containing products in the past 14 days.
- 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:
- 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.
- 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.
- Intent to proceed with endovascular thrombectomy (EVT) for the index AIS event based on eligibility and direct availability.
- Seizure at time of index AIS event onset, only if it precludes accurate assessment of baseline NIHSS.
- Persistent blood pressure elevation (systolic >=185 millimeters of mercury [mmHg] or diastolic >=110 mm Hg) prior to randomization.
- Blood glucose <50 milligrams per deciliter (mg/dL) or >400 mg/dL.
- Current Medical Conditions:
- Active, uncontrolled bleeding.
- Bleeding diathesis or any other conditions that would pose significant bleeding risk.
- Inability to undergo MRI or CT.
- Chronic causative intracranial occlusion.
- Causative total occlusion of the extracranial ICA.
- Evidence of septic emboli or bacterial endocarditis.
- Another clinically significant concomitant disease that may pose additional risks for the participant in the opinion of the investigator.
- Pregnancy, lactation, or unable to comply with birth control methods or abstinence as specified in the protocol in the opinion of the investigator.
- Imaging:
- Poor quality imaging that precludes interpretation according to trial protocol.
- Evidence of significant intracranial mass effect or midline shift.
- 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.
- 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).
- 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.
- Evidence of intracranial tumor (except incidental, small meningioma), cerebral aneurysm, or arteriovenous malformation.
- Laboratory:
- Platelet count <50,000/ cubic millimeters (mm^3).
- Other:
- Identification by the investigator as being potentially unable or unwilling to cooperate with trial procedures.
Trial locations and contacts
60 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
60 sites in 10 countries
United States9 sites, 9 recruiting
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Site Contact, 857-238-5644, wtkimberly@mgh.harvard.edu
W. Taylor Kimberly
- Not yet recruiting
University at Buffalo
Buffalo, New York, 14202
Site Contact, 716-829-5046, marilouching@aol.com
Marilou Ching
- Not yet recruiting
HCA Houston Healthcare - North Cypress
Cypress, Texas, 77429
Site Contact, 330-503-8301, Sushrut.Dharmadhikari@hcahealthcare.com
Sushrut Dharmadhikari
- Not yet recruiting
Neurology Consultants of Dallas, PA
Dallas, Texas, 75243
Site Contact, 214-750-9977, rcheung@neurologydallas.com
Ryan Cheung
- Not yet recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Site Contact, 615-875-0406, m.froehler@vanderbilt.edu
Michael Froehler
- Not yet recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Site Contact, 412-647-8071, bhattnr@upmc.edu
Nirav Bhatt
- Not yet recruiting
University of California San Francisco
San Francisco, California, 94143
Site Contact, 415-364-8649, anthony.kim@ucsf.edu
Anthony Kim
- Recruiting
HonorHealth Neurology
Scottsdale, Arizona, 85251
Site Contact, 480-583-0192, ashutosh.jadhav@barrowbrainandspine.com
Ashutosh Jadhav
- Not yet recruiting
University of Arizona
Tucson, Arizona, 85724
Site Contact, 203-314-6767, firaskaddouh@arizona.edu
Firas Kaddouh
China8 sites, 8 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Site Contact, 86 15710088948, yongjunwang111@aliyun.com
Yongjun Wang
- Recruiting
Sinopharm Tongmei General Hospital
Datong, Shanxi, 037000
Site Contact, 86 13753265757, wjh1964@sohu.com
Junhai Wang
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Site Contact, 86 18560082121, wuwei7172@126.com
Wei Wu
- Recruiting
Liaocheng People's Hospital
Liaocheng, Shandong, 252000
Site Contact, 86 13396258699, guodonglc8699@163.com
Dong Guo
- Recruiting
Linfen Central Hospital
Linfen, Shanxi, 041099
Site Contact, 86 15935767592, daihongguo3199@163.com
Hongguo Dai
- Recruiting
Linyi People's Hospital
Linyi, Shandong, 276000
Site Contact, 86 13954993801, wzr0806@163.com
Ziran Wang
- Recruiting
Nanshi Hospital of Nanyang
Nanyang, Henan, 473003
Site Contact, 86 13525181800, 2207988910@qq.com
Xiaohua Xiao
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Site Contact, 86 18052268195, xyfychengyanbo@163.com
Yanbo Cheng
Brazil7 sites, 7 recruiting
- Not yet recruiting
Universidade Estadual Paulista Julio de Mesquita Filho Faculdade de Medicina Campus de Botucatu
Botucatu, São Paulo, 18618-687
Site Contact, 55 14 981157727, bazanr@fmb.unesp.br
Rodrigo Bazan
- Not yet recruiting
Universidade Estadual de Campinas (UNICAMP)
Campinas, São Paulo, 13083-888
Site Contact, 55 19 35218242, Wagner.avelar@gmail.com
Wagner Mauad Avelar
- Not yet recruiting
Porto Alegre Clinical Hospital (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-903
Site Contact, 55 51 999628467, scmartins@hcpa.edu.br
Sheila Cristina Ouriques Martins
- Recruiting
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90560-032
Site Contact, 55 51 999584631, leonardo.carbonera@hmv.org.br
Leonardo Augusto Carbonera
- Not yet recruiting
Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - Universidade de Sao Paulo
Ribeirão Preto, São Paulo, 14048-900
Site Contact, 55 16 997815464, opontesneto@fmrp.usp.br
Octavio Marques Pontes-Neto
- Not yet recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
Site Contact, 55 17 32015054, marianabattaglini81@gmail.com
Mariana Neves Marques Battaglini
- Not yet recruiting
Hospital Sao Paulo / Escola Paulista de Medicina da Universidade Federal de Sao Paulo (EPM/UNIFESP)
São Paulo, São Paulo, 04022-001
Site Contact, 55 11 983580583, giselesampaio@hotmail.com
Gisele Sampaio Silva
Germany7 sites, 7 recruiting
- Not yet recruiting
Charite Universitatsmedizin Berlin
Berlin, 12203
Site Contact, 49 30450660843, jan.scheitz@charite.de
Jan Scheitz
- Not yet recruiting
Technische Universitaet Dresden-Universitaetsklinikum Carl Gustav Carus
Dresden, Saxony, 01307
Site Contact, 49 35145819692, martin.arndt@ukdd.de
Martin Arndt
- Not yet recruiting
Goethe-Universitaet-Universitaetsmedizin Frankfurt-Zentrum der Neurologie und Neurochirurgie (ZNN)
Frankfurt am Main, Hesse, 60590
Site Contact, 49 69630187745, janhendrik.schaefer@kgu.de
Jan Hendrick Schaefer
- Not yet recruiting
Universitaetsmedizin Goettingen
Göttingen, Lower Saxony, 37075
Site Contact, 49 5513965628, ilko.maier@med.uni-goettingen.de
Ilko Maier
- Not yet recruiting
Universitaetsklinikum Heidelberg (UKHD)
Heidelberg, Baden-Wurttemberg, 69120
Site Contact, 49 6221566999, jan.purrucker@med.uni-heidelberg.de
Jan Purrucker
- Not yet recruiting
Klinikum Ernst von Bergmann
Potsdam, Brandenburg, 14467
Site Contact, 49 33124137118, andrea.rocco@klinikumevb.de
Andrea Rocco
- Not yet recruiting
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Site Contact, 49 70712968293, annerose.mengel@med.uni-tuebingen.de
Annerose Mengel
Belgium5 sites, 5 recruiting
- Not yet recruiting
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Site Contact, 32 89 804022, sam.vanboxstael@zol.be
Sam Van Boxstael
- Not yet recruiting
Universitair Ziekenhuis Gent (Belgium,Ghent)
Ghent, Oost-Vlaanderen, 9000
Site Contact, 32 9 3324529, dimitri.hemelsoet@ugent.be
Dimitri Hemelsoet
- Not yet recruiting
AZ Groeninge
Kortrijk, WVL, 8500
Site Contact, 32 473725381, peter.vanacker@uza.be
Peter Vanacker
- Not yet recruiting
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
Liège, 4000
Site Contact, 32 43234049, jly@chuliege.be
Julien Ly
- Not yet recruiting
Groupe sante CHC - Clinique du MontLegia
Liège, 4000
Site Contact, 32 4 3554030, philippe.desfontaines@chc.be
Philippe Desfontaines
France5 sites, 5 recruiting
- Not yet recruiting
CHU Bordeaux, CHU Pellegrin
Bordeaux, Aquitaine, 33076
Site Contact, 33 0557820957, igor.sibon@chu-bordeaux.fr
Igor Sibon
- Not yet recruiting
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Raymond-Poincare
Garches, IDF, 92380
Site Contact, 33 0147107234, sandrine.deltour@aphp.fr
Sandrine Deltour Bouard
- Not yet recruiting
Bicetre Hospital
Le Kremlin-Bicêtre, IDF, 94270
Site Contact, 33 014522403, christian.denier@bct.aphp.fr
Christian Denier
- Not yet recruiting
Groupe Hospitalier Bichat Claude Bernard
Paris, IDF, 75018
Site Contact, 33 0621661391, elena.meseguer@aphp.fr
Elena Meseguer
- Not yet recruiting
Hopital Lariboisiere
Paris, IDF, 78600
Site Contact, 33 0603347303, mikael.mazighi@aphp.fr
Mikael Mazighi
India5 sites, 5 recruiting
- Not yet recruiting
AES - AS - KLES Dr Prabhakar Kore Hospital and Medical Research Centre
Belagavi, Karnataka, 590010
Site Contact, 91 9448468474, sarojaao2002@gmail.com
Aralikatte Saroja
- Not yet recruiting
Amrita Institute Of Medical Sciences and Research Centre
Kochi, Kerala, 682041
Site Contact, 91 8921485541, dr.vivek.in@gmail.com
Vivek Nambiar
- Not yet recruiting
Bangur Institute of Neurosciences
Kolkata, West Bengal, 700020
Site Contact, 91 9433185327, biman.kanti@rediffmail.com
Biman Kanti Ray
- Not yet recruiting
Christian Medical College, Ludhianana
Ludhiana, Punjab, 141008
Site Contact, 91 9915784750, ivy29cmc@gmail.com
Ivy Anne Sebastian
- Not yet recruiting
All India Institute of Medical Sciences, New Delhi, Department of Neurology
New Delhi, 110029
Site Contact, 91 8193900444, ayushthetaurian@gmail.com
Ayush Agarwal
Japan5 sites, 5 recruiting
- Recruiting
Saiseikai Fukuoka General Hospital
Fukuoka, Fukuoka, 810-0001
Site Contact, 81 927718151, kazutaka.sonoda@gmail.com
Kazutaka Sonoda
- Recruiting
Fukuoka Wajiro Hospital
Fukuoka, Fukuoka, 811-0213
Site Contact, 81 926080001, fukuyama.wajiro.chiken@f-wajirohp.jp
Kozo Fukuyama
- Not yet recruiting
Rinku General Medical Center
Izumisano, Osaka, 598-8577
Site Contact, 81 724693111, yhagi@qf6.so-net.ne.jp
Yasushi Hagihara
- Recruiting
Nagano Municipal Hospital
Nagano, Nagano, 381-8551
Site Contact, 81 262951199, yoshikazu_kusano@hospital.nagano.jp
Yoshikazu Kusano
- Not yet recruiting
Kotobukikai Tominaga Hospital
Osaka, Osaka, 556-0017
Site Contact, 81 665681601, k.m.chiken2019@gmail.com
Ko Matsuda
United Kingdom5 sites, 5 recruiting
- Not yet recruiting
Aberdeen Royal Infirmary
Cornhill, Aberdeen, AB25 2ZD
Site Contact, 44 7771361243, m.j.macleod@abdn.ac.uk
Mary Macleod
- Not yet recruiting
University of Glasgow - PPDS
Glasgow, Lanarkshire, G4 0SF
Site Contact, 44 7967340243, Terry.quinn@glasgow.ac.uk
Terence Quinn
- Not yet recruiting
NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital
Glasgow, Lanarkshire, G51 4TF
Site Contact, 44 1414515892, amith.sitaram2@nhs.scot
Amith Sitaram
- Not yet recruiting
Imperial College Healthcare NHS Trust, St. Mary's Hospital
London, W2 1NY
Site Contact, 44 2033115049, dheeraj.kalladka@nhs.net
Dheeraj Kalladka
- Not yet recruiting
Bedfordshire Hospitals NHS Foundation Trust
Luton, Bedfordshire, LU4 0DZ
Site Contact, 44 1582497140, lakshmanan.sekaran@ldh.nhs.uk
Sekaran Lakshmanan
Greece4 sites, 4 recruiting
- Not yet recruiting
University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
Site Contact, 30 6972699035, vadikosm@yahoo.com
Konstantinos Vadikolias
- Not yet recruiting
Athens Navy Hospital
Athens, 11521
Site Contact, 30 2107261148, michael_ioakeimidis@hotmail.com
Michail Ioakeimidis
- Not yet recruiting
Second Department of Neurology, National and Kapodistrian University of Athens, "Attikon" University Hospital
Chaïdári, Attica, 12462
Site Contact, 30 6937178635, tsivgoulisgiorg@yahoo.gr
Georgios Tsivgoulis
- Not yet recruiting
AHEPA University General Hospital of Thessaloniki
Thessaloniki, 54636
Site Contact, 30 6937037253, tkarapanayiotides@yahoo.gr
Theodoros Karapanayiotides
About this study
Official title: 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- TAK-755, Placebo
- Keywords
- Drug therapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-755Biological
Also called rADAMTS13
TAK-755 IV infusion.
PlaceboOther
TAK-755 matching placebo IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Part A: TAK-755 | 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. Receives: Biological: TAK-755 |
| Part B: TAK-755 | 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. Receives: Biological: TAK-755 |
| Part A and B: Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A and B: Percentage of Participants who Develop Symptomatic Intracranial Hemorrhage (sICH) as Defined by the Heidelberg Bleeding Classification System
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.
Measured: Up to 120 hours of study drug administration
Secondary outcomes (16)
Part A: Percentage of Participants With Treatment-Related and Unrelated Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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.
Measured: From start of study drug administration up to follow-up (up to 90 days)
Part A: Percentage of Participants With Severe TEAEs
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.
Measured: 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)
Percentage of participants with life-threatening AEs will be reported.
Measured: From start of study drug administration up to follow-up (up to 90 days)
Part A: Percentage of Participants With AEs of Special Interest (AESIs)
AESIs include sICH, treatment-related aICH, treatment-related extracranial bleeding SAEs, and recurrent AIS. Percentage of participants with AESIs will be reported.
Measured: From start of study drug administration up to 168 hours
Part A: Percentage of Participants With Clinically Relevant Changes in Vital Signs
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.
Measured: From screening up to 90 days
Part A: Percentage of Participants With Clinically Relevant Changes in Clinical Chemistry and Hematology
Laboratory parameters will include clinical chemistry and hematology. Any clinically relevant changes in laboratory values will be determined at the investigator's discretion.
Measured: From screening up to 90 days
Part A: Number of Participants With Treatment-induced Binding Antibodies to ADAMTS13
As per planned analysis, blood sample will be collected to monitor the development of binding antibodies to ADAMTS13.
Measured: From Day 30 to Day 90
Part A: Number of Participants With Treatment-induced Neutralizing Antibodies to ADAMTS13
As per planned analysis, blood sample will be collected to monitor the development of neutralizing antibodies to ADAMTS13.
Measured: From Day 30 to Day 90
Part A: Percentage of Participants With All-cause Mortality
Percentage of participants who died during the entire study period will be reported.
Measured: 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
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.
Measured: At Day 90
Part A and B: Percentage of Participants With mRS Score of 0-2
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.
Measured: At Day 90
Part A and B: Ordinal Distribution of mRS 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.
Measured: At Day 90
Part A and B: Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) Score at 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.
Measured: Baseline up to 24 hours
Part A and B: Percentage of Participants With Recanalization According to Arterial Occlusive Lesion (AOL) Score of 3
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.
Measured: At 24 Hours
Part A and B: Percentage of Participants With Reperfusion
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.
Measured: At 24 Hours
Part A and B: Final Infarct Volume
Final infarct volume at 72 hours or hospital discharge (if earlier than 72 hours) will be reported.
Measured: At 72 hours or earlier at hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start17 May 2026
- Primary completion6 Dec 2027 (estimated)
- Study completion6 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392450
- Sponsor's protocol ID
- TAK-755-2002
- Other IDs
- jRCT2071260013
- Status last verified
- Aug 2026
- First submitted
- 30 Jan 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.