TAK-755 for Stroke
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called TAK-755, an experimental therapy, to determine its safety and effectiveness for people with acute ischemic stroke (AIS), a condition where blood flow to the brain is blocked. The study compares TAK-755 to a placebo to assess its impact on reducing stroke symptoms and improving daily activities. Participants will receive one dose of either TAK-755 or a placebo and will be monitored for about three months. The trial seeks adults who have experienced stroke symptoms within the past 24 hours. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in stroke treatment.
Is there any evidence suggesting that TAK-755 is likely to be safe for humans?
Research has shown that TAK-755 has been safe in previous studies. One study found that TAK-755 reduced thrombocytopenia events, which occur when blood platelet counts are low, by 60%. This reduction suggests the drug might be safer and more effective than some other options. The findings indicate that TAK-755 is generally well-tolerated, with most participants not experiencing serious side effects. While researchers are testing TAK-755 for stroke treatment, it has also been studied for a rare blood disorder, showing similar safety results. Since this trial is in the early stages for stroke, the primary focus is on ensuring participant safety.12345
Why do researchers think this study treatment might be promising for stroke?
Most treatments for stroke focus on restoring blood flow or reducing damage after a stroke has occurred. However, TAK-755 is unique because it targets a specific enzyme deficiency that might contribute to stroke severity. Unlike standard therapies, which often involve clot-busting drugs or surgery, TAK-755 is an intravenous infusion designed to address the underlying biochemical factors. Researchers are excited about this treatment because it offers a new approach that could potentially prevent further damage by addressing the root cause, not just the symptoms. This innovative mechanism has the potential to improve outcomes for stroke patients in a way current treatments cannot.
What evidence suggests that TAK-755 might be an effective treatment for stroke?
Research has shown that TAK-755 might help manage symptoms of acute ischemic stroke (AIS). TAK-755 replaces an enzyme called ADAMTS13, which helps prevent blood clots. In studies on other conditions like cTTP, a blood disorder, TAK-755 reduced blood-related problems by 60%. This suggests it might also help with blood flow issues in strokes. Early findings indicate that TAK-755 may assist stroke patients with daily activities and reduce stroke severity. These promising results have led to the study of TAK-755 for stroke treatment in this trial, where participants will receive either TAK-755 or a placebo.12367
Who Is on the Research Team?
Study Director
Principal Investigator
Takeda
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intravenous (IV) infusion of TAK-755 or placebo on Day 1
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TAK-755
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier
Citations
1.
globalgenes.org
globalgenes.org/raredaily/takeda-reports-favorable-phase-3-safety-and-efficacy-results-of-enzyme-replacement-therapy-in-cttp/Takeda Reports Favorable Phase 3 Safety and Efficacy ...
The interim results showed that TAK-755 reduced the incidence of thrombocytopenia events by 60 percent, an important marker of disease ...
A Study of TAK-755 in Participants With Congenital ...
TAK-755 is a medicine that replaces ADAMTS13 and may prevent or control TTP flare-ups, called acute TTP events.
A Study of TAK-755 in Adults With Acute Ischemic Stroke
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.
4.
takeda.com
takeda.com/newsroom/newsreleases/2023/pivotal-phase-3-data-presented-at-isth-2023-congress/Strong Efficacy and Safety of TAK-755 in cTTP Phase 3 Trial
Takeda presents favorable results from Phase 3 trial of TAK-755 for cTTP treatment. Reduced thrombocytopenia by 60% and increased ADAMTS13 ...
5.
clinicaltrials.takeda.com
clinicaltrials.takeda.com/study-detail/dfc4c8723ddb41f8??page=1&idFilter=TAK-755-2002A Study of TAK-755 in Adults With Acute Ischemic Stroke
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.
Takeda Announces Favorable Phase 3 Safety and Efficacy ...
The interim results showed that TAK-755 reduced the incidence of thrombocytopenia events by 60% (95% Confidence Interval, 30%-70%), an ...
NCT05714969 | A Study of TAK-755 (rADAMTS13) With ...
The main aim of this study is to determine the percentage of participants with a clinical (Part 1) or platelet (Part 2) response without plasma exchange during ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.