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Study on the Safety of TAK-755, Rituximab, and Glucocorticoids for Patients with Immune-Mediated Thrombotic Thrombocytopenic Purpura (iTTP)

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a rare blood disorder called immune-mediated thrombotic thrombocytopenic purpura (iTTP). This condition causes blood clots to form in small blood vessels, leading to a low platelet count, which can result in bleeding and other serious health issues. The study is testing a treatment called TAK-755 (rADAMTS13), which is a type of protein therapy designed to help manage this condition. The trial will also involve the use of other medications, including Rituximab, a monoclonal antibody, and Glucocorticoids, which are a type of steroid medication.

The purpose of the study is to assess the safety of TAK-755 in treating patients with iTTP. Participants in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will compare the effects of TAK-755 with minimal or no plasma exchange, a procedure that is often used to treat iTTP by removing and replacing the plasma in the blood. The trial will monitor participants over a period to observe any side effects and to see how well the treatment works in managing the disease.

Throughout the study, researchers will track various health indicators to understand the treatment's impact on the disease. This includes monitoring the occurrence of any adverse events, the time it takes for patients to respond to the treatment, and any changes in specific blood markers. The study aims to provide valuable information on how TAK-755 can be used to treat iTTP effectively and safely, potentially offering a new option for managing this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be required to provide a signed informed consent form. This is a document that confirms the patient's understanding and agreement to participate in the study.

    The patient must be 18 years or older and have been diagnosed with immune-mediated thrombotic thrombocytopenic purpura (iTTP).

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm the diagnosis of iTTP. This includes checking the platelet count and looking for signs of hemolytic anemia, such as elevated levels of lactate dehydrogenase (LDH) or the presence of schistocytes in the blood.

  3. Step 3

    Treatment administration

    The patient will receive the medication TAK-755, also known as recombinant ADAMTS13 (rADAMTS13), through an intravenous infusion. This means the medication will be administered directly into the bloodstream.

    The frequency and dosage of the medication will be determined by the study protocol and the patient's response to treatment.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the patient will be monitored for any side effects or adverse events. This includes regular blood tests to check for changes in platelet count and other relevant biomarkers.

    The study aims to assess the safety and effectiveness of TAK-755 in treating iTTP, with minimal to no plasma exchange (PEX).

  5. Step 5

    Completion of study

    The study is expected to be completed by December 2025. Upon completion, the patient's health and response to the treatment will be evaluated to determine the overall effectiveness of the medication.

    The patient will be informed of the study results and any further steps if necessary.

Who can join the trial?

6 criteria

  • The person must sign a form to show they agree to join the study. If they can't sign, someone legally allowed to sign for them can do it.
  • The person must be 18 years old or older when they are checked for the study.
  • The person must have been diagnosed with **iTTP**, which is a condition involving low platelets and broken red blood cells. This is shown by:
    • **Thrombocytopenia**: This means having a low number of platelets, which are cells that help stop bleeding. The count should be less than 100,000 per microliter.
    • **Microangiopathic hemolytic anemia**: This means the red blood cells are being destroyed. It is shown by high levels of **LDH** (a substance in the blood) being more than twice the normal limit, or by seeing broken red blood cells in a blood test.
    • The person must agree to follow all the study rules and procedures.
    • Women who can have children must have a negative pregnancy test and agree to use very effective birth control during the study. Men who are sexually active must agree to use effective birth control during the study.

Who cannot join the trial?

1 criterion

  • There are no specific reasons listed that would prevent a patient from participating in this study.
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Investigated drugs

TAK-755 (rADAMTS13) is a medication being studied for its safety and effectiveness in treating a condition called immune-mediated thrombotic thrombocytopenic purpura (iTTP). This condition involves the formation of small blood clots throughout the body, which can lead to serious health problems. TAK-755 is designed to help break down these clots and improve blood flow, potentially reducing the symptoms and complications associated with iTTP.

What is already known about the treatment

TAK-755 – TAK-755 is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials, specifically in a Phase 2b study, to evaluate its safety and effectiveness in treating immune-mediated thrombotic thrombocytopenic purpura (iTTP). This medication is designed to replace a missing enzyme called ADAMTS13, which helps regulate blood clotting by breaking down a specific protein in the blood. TAK-755 is classified as a recombinant enzyme therapy, aiming to restore normal blood clotting function in patients with iTTP.

Investigated diseases

Immune-mediated thrombotic thrombocytopenic purpura (iTTP) – This is a rare blood disorder characterized by the formation of small blood clots throughout the body, which can lead to a low platelet count. The disease occurs when the immune system mistakenly attacks an enzyme called ADAMTS13, which is responsible for regulating blood clotting. As a result, large molecules of von Willebrand factor accumulate, causing platelets to clump together and form clots. These clots can block small blood vessels, leading to various symptoms such as fatigue, bruising, and neurological issues. The progression of iTTP can be unpredictable, with periods of remission and exacerbation. It requires careful monitoring to manage the symptoms and prevent complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507787-39-00Protocol codeTAK-755-2001Estimated enrolment36 patientsSponsorTakeda Development Center Americas Inc.

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