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

NCT07392450 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TAK-755-2002
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief 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). 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

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  From start of study drug administration up to follow-up (up to 90 days)

• Part A: Percentage of Participants With Severe TEAEs

  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)

  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)

  From start of study drug administration up to follow-up (up to 90 days)

• Part A: Percentage of Participants With Clinically Relevant Changes in Vital Signs

  From screening up to discharge (up to approximately 8 days)

Study Arms (3)

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.

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.

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.

Other: Placebo

Interventions

TAK-755 BIOLOGICAL

TAK-755 IV infusion.

Also known as: rADAMTS13

Part A: TAK-755; Part B: TAK-755

Placebo OTHER

TAK-755 matching placebo IV infusion.

Part A and B: Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent:
• The participant or legally authorized representative has provided informed consent before the initiation of any trial procedures.
• Age:
• to 80 years of age, inclusive, at the time of signing the informed consent form.
• Clinical Characteristics:
• Clinical diagnosis of AIS.
• 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.
• National Institutes of Health Stroke Scale score of 6 to 25, indicating moderate to severe stroke.
• Estimated Modified Rankin Scale score less than (\<) 2 prior to AIS presentation, signifying no significant disability.
• Signs and symptoms consistent with anterior circulation stroke.
• Imaging:
• Evidence of causative AIS occlusion on imaging (intracranial internal carotid artery \[ICA\], M1, M2, M3, M4, A1, A2, A3).
• Evidence of salvageable brain tissue on CT or MR imaging.

You may not qualify if:

• 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.
• 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.
• History of systemic malignancy, 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Honor Health

Scottsdale, Arizona, 85251, United States

RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): December 6, 2027
• Study Completion (Estimated): December 6, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

US (1)