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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Takeda
Study ID
NCT07392450
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • TAK-755 — BIOLOGICAL
    TAK-755 IV infusion.
  • Placebo — OTHER
    TAK-755 matching placebo IV infusion.

Study Details

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.

Key Dates

Start date
Apr 7, 2026
Status verified
Apr 2026
Primary completion
Dec 6, 2027
Completion
Dec 6, 2027

Study Design

Enrollment
222 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Honor HealthScottsdaleArizona85251
Site Contact
[email protected]
602-258-2863
Ashutosh Jadhav (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Honor Health· Scottsdale, AZ

Related Studies