Not yet recruitingRare disease

Study on the Safety and Effectiveness of Budoprutug in Patients with Immune Thrombocytopenia

Verified siteInvestigationalNo 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 condition called Immune Thrombocytopenia (ITP), which is a disorder that can lead to easy or excessive bruising and bleeding due to low levels of platelets in the blood. The study will use a treatment called Budoprutug, also known by its code name TNT119. Budoprutug is a type of protein known as a monoclonal antibody, which is designed to target specific cells in the immune system.

The purpose of the study is to evaluate the safety and tolerability of different doses of Budoprutug in people with ITP. Participants will receive Budoprutug through an intravenous infusion, which means the medication will be given directly into a vein. The study will be conducted in phases, starting with smaller doses and gradually increasing to find the most effective and safe dose. Researchers will monitor participants for any side effects and changes in their platelet counts over time.

Throughout the study, researchers will also look at how Budoprutug is processed in the body, including how long it stays in the bloodstream and how it affects the immune system. The study aims to see if Budoprutug can help increase platelet counts and improve the condition of people with ITP. Participants will be observed for any changes in their health and any potential benefits from the treatment. The study is expected to continue until 2028, with recruitment starting in 2025.

The research process

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

Step 1
Joining the study
Upon joining the study, you will be introduced to the trial's purpose and procedures. This study is designed to evaluate the safety and effectiveness of a medication called budoprutug in individuals with a condition known as immune thrombocytopenia (ITP).
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes checking your platelet count, which should be less than 30,000 per microliter, and ensuring that you have tried at least one previous treatment for ITP.
Additional tests will be performed to ensure adequate blood, liver, and kidney function. If you are on certain medications like corticosteroids, your dosage must be stable before starting the study.
Step 3
Medication administration
You will receive the study medication, budoprutug, through an intravenous infusion. This means the medication will be given directly into your vein using a needle.
The dosage of budoprutug will be gradually increased to find the most effective and safe dose for you.
Step 4
Monitoring and follow-up
Throughout the study, regular monitoring will be conducted to observe how your body responds to the medication. This includes checking for any side effects and measuring changes in your platelet count.
You will have scheduled visits to assess the medication's impact on your condition and overall health.
Step 5
Completion of study
At the end of the study, a final assessment will be conducted to evaluate the overall effects of the medication on your condition.
The study aims to determine if budoprutug can safely improve platelet counts and reduce the need for other treatments in individuals with ITP.

Who can join the trial?

6 criteria

Must be over 18 years old.
Have a platelet count (a type of blood cell that helps with clotting) of less than 30,000 per microliter, even after trying at least one previous treatment. This low platelet count must be confirmed twice, with tests done at least 5 days apart but no more than 14 days apart.
Have a partial thromboplastin time (a blood test that measures how long it takes for blood to clot) less than 1.5 times the upper limit of normal, a prothrombin time (another blood clotting test) less than 1.5 times the upper limit of normal, and total bilirubin (a substance made by the liver) less than 1.5 times the upper limit of normal unless you have Gilbert’s syndrome (a mild liver disorder). The international normalized ratio (a standardized number that's figured out in the lab) should also be less than 1.5 at screening.
Have adequate blood, liver, and kidney function.
If taking corticosteroids (a type of medication that reduces inflammation) or thrombopoietin (TPO) agonists (medications that help increase platelet production), the dose must be stable (less than 20% change) for 14 days before starting the study drug. Corticosteroid treatment should not be more than 1 mg per kg of methylprednisolone (or equivalent) for 2 weeks before starting the study drug.
Must have a diagnosis of primary Immune Thrombocytopenia (ITP).

Who cannot join the trial?

12 criteria

Patients with any other **autoimmune diseases**. These are conditions where the body's immune system attacks its own cells.
Patients who have had a **splenectomy**. This is a surgery to remove the spleen.
Patients who are currently taking other medications that affect the **immune system**. The immune system is the body's defense against infections and diseases.
Patients with a history of **cancer** within the last 5 years, except for some skin cancers.
Patients with **active infections** that require treatment.
Patients who have received a **live vaccine** within 4 weeks before the study. Live vaccines contain a small amount of the actual virus or bacteria.
Patients with **uncontrolled high blood pressure**. This means blood pressure that is not managed well with medication.
Patients with **heart problems** that are not stable.
Patients with **liver disease** that is severe.
Patients with **kidney disease** that is severe.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.

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Verified sites

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Verified
Hospital Universitario 12 De Octubre
Madrid, Spain
Verified
Hospital Universitario da A Coruna
A Coruna Galicia, Spain
Verified
Laiko General Hospital Of Athens
Athens, Greece

Trial locations

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Investigated drugs

Budoprutug (TNT119) is a medication being studied for its potential to help people with a condition called Immune Thrombocytopenia (ITP). ITP is a disorder where the immune system mistakenly attacks and destroys platelets, which are cells in the blood that help with clotting. This can lead to easy bruising and bleeding. The purpose of this study is to see if Budoprutug is safe and well-tolerated by patients, and to understand how it behaves in the body. Researchers are also looking at whether it can effectively help increase platelet counts in people with ITP. This study involves gradually increasing the dose of Budoprutug to find the best amount that can be given safely.

BUDOPRUTUG

What is already known about the treatment

Budoprutug (TNT119) – Budoprutug is administered in a clinical trial setting to evaluate its safety and effectiveness for treating Immune Thrombocytopenia (ITP), a condition where the immune system attacks and destroys platelets in the blood. This medication is given in increasing doses to study its effects, and it is currently in the early stages of clinical research, meaning it is not yet widely available or fully approved for general medical use. Budoprutug works by targeting specific pathways in the immune system to help prevent the destruction of platelets, potentially improving platelet counts in patients with ITP. It is classified as an investigational drug, which means it is still being studied to understand its full potential and safety profile.

Investigated diseases

Immune Thrombocytopenia (ITP) – Immune Thrombocytopenia is a disorder characterized by a low platelet count, which can lead to easy or excessive bruising and bleeding. The condition occurs when the immune system mistakenly attacks and destroys platelets, which are essential for normal blood clotting. ITP can develop suddenly or gradually and may be temporary or chronic. Symptoms often include petechiae, which are small red or purple spots on the skin, and purpura, which are larger areas of bleeding under the skin. The progression of ITP varies, with some individuals experiencing mild symptoms while others may have more severe bleeding episodes. The disease can affect both children and adults, with different patterns of progression in each group.