RecruitingPHASE3INTERVENTIONAL

A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

This study is for adults with a condition called Immune Thrombocytopenia (ITP). ITP causes your body to destroy tiny blood cells called platelets, which help your blood clot. This can lead to bruising and bleeding easily. We are trying to find out if a new medicine called mezagitamab can help keep platelet counts stable in people with ITP. Participants will receive either mezagitamab or a dummy medicine (placebo) by injection under the skin for up to 6 months. We then look at how each group's platelet counts change. Some people might also have the chance to continue taking mezagitamab after the main study ends.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Takeda

Enrolment target

171

Start

27 Feb 2025

Estimated completion

16 Mar 2028

Immune Thrombocytopenic Purpura (ITP)

What is this study about?

This study is focused on a condition called Immune Thrombocytopenia, or ITP. If you have ITP, your body's defence system, called the immune system, mistakenly attacks and destroys your platelets. Platelets are really important because they are tiny cells in your blood that help it to clot and stop bleeding. When you don't have enough platelets, you might bruise easily, notice small red spots on your skin, or experience nosebleeds or gum bleeding.

We are looking into a new medicine called mezagitamab. The main goal of this study is to see if mezagitamab can effectively help keep your platelet count at a healthy and stable level compared to a placebo. A placebo looks exactly like the real medicine but doesn't contain any active ingredients. This helps us understand if any improvements are truly due to the new medicine.

Participants in the study will receive mezagitamab or the placebo as an injection just under the skin. This treatment will continue for up to six months. We hope this study will give us important information about whether mezagitamab could be a helpful new treatment option for people living with ITP.

Key takeaways

This study is testing a new medicine (mezagitamab) for adults with ITP.
It aims to see if mezagitamab can help keep platelet counts stable.
You might receive the new medicine or a dummy treatment (placebo).
Treatment is given by injection under the skin for up to 6 months.
Regular clinic visits are required to monitor your health.
There's a chance to continue with mezagitamab after the main study, if eligible.

Who may be eligible?

This study is for adults aged 18 and over who have been diagnosed with ITP for at least a year. You would need to have shown a good response to an ITP treatment in the past (but not a type called a TPO-RA), and your current platelet count should be less than 30,000.

You also need to have tried and not responded well to or couldn't tolerate at least two different types of ITP treatment – one first-line treatment (like steroids) and at least one second-line treatment (like TPO-RAs, rituximab, fostamatinib, or mycophenolate). If you're using other ITP treatments, they need to have been at a steady dose for at least a month before the study starts and expected to stay the same throughout.

You wouldn't be able to join if your ITP is due to another medical condition (called secondary ITP), if you've had a blood clot or stroke in the last year, have had your spleen removed, or have certain active infections like Hepatitis B, C, or HIV. A history of certain cancers would also mean you couldn't take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am 18 years old or older.
I have been diagnosed with ITP for at least one year.
My current platelet count is less than 30,000.
I have tried at least two different ITP treatments (like steroids and another type) in the past, and they either didn't work well enough or caused too many side effects.
I have not had a blood clot or stroke in the past year.
I do not have Hepatitis B, C, or HIV.

Answer every question to see your result.

What does participation involve?

If you join the study, you'll receive the study medicine (mezagitamab or a placebo) as an injection under your skin for up to 6 months. Throughout this time, you'll need to visit the study clinic several times. These visits will involve checks to see how you are doing, including blood tests to measure your platelet count and general health. The doctors will also ask you questions about any side effects you might be experiencing.

After the main study finishes, or if the treatment doesn't seem to be working for you after 16 weeks, you may get the chance to join a follow-on study. In this continuation study, eligible participants would receive mezagitamab openly, meaning they would know they are getting the active medicine. The doctors will explain more about this if it applies to you.

Potential risks and benefits

Taking part in a clinical trial can have potential benefits, like gaining access to a new medicine before it's widely available, and helping doctors learn more about ITP and its treatment. However, there are also potential risks, such as side effects from the medicine or the extra clinic visits required. You might receive the placebo, which means you won't get the active study drug. Your health will be carefully monitored throughout the study, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (112)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

USC Norris Comprehensive Cancer Center - Keck Medicine of USC
Verified postcode
Los Angeles, United States· Recruiting
Rocky Mountain Cancer Center
Verified postcode
Denver, United States· Withdrawn
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
Verified postcode
Washington D.C., United States· Recruiting
Emory University
Verified postcode
Atlanta, United States· Recruiting
The University of Iowa
Verified postcode
Iowa City, United States· Recruiting
University Of Louisville Brown Cancer Center
Verified postcode
Louisville, United States· Recruiting
American Oncology Partners of Maryland, PA
Verified postcode
Bethesda, United States· Not yet recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting
University of Massachusetts Chan Medical School
Verified postcode
Worcester, United States· Recruiting
Duke University Hospital
Verified postcode
Durham, United States· Recruiting
East Carolina University
Verified postcode
Greenville, United States· Recruiting
Oregon Health & Science University
Verified postcode
Portland, United States· Recruiting

Common questions

What is ITP?

ITP (Immune Thrombocytopenia) is a condition where your immune system mistakenly destroys your platelets, which are tiny cells that help your blood clot. This can lead to easy bruising and bleeding.

What is mezagitamab?

Mezagitamab is the new medicine being tested in this study. We want to see if it can help keep platelet counts stable in people with ITP.

What is a placebo?

A placebo is a dummy medicine. It looks exactly like the study medicine but contains no active ingredients. It helps doctors work out if the real medicine is having an effect.

How will I receive the study medicine?

The study medicine (mezagitamab or placebo) will be given as an injection just under your skin.

How long will I be in the study?

You will receive the study medicine for up to 6 months, and there will be several follow-up visits during and after this period.

How to find out more

Takeda Contact

medinfoUS@takeda.com +1-877-825-3327 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.