RecruitingPHASE3INTERVENTIONAL

A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

This research study is about a medicine called mezagitamab, which is being tested in adults who have a health problem called Immune Thrombocytopenic Purpura (ITP). ITP is a condition where your body’s defence system mistakenly harms your platelets, making it harder for your blood to clot. The main goal of this study is to see how safe mezagitamab is and if people can tolerate it well over a longer period. We also want to understand how effective it is and how your body uses the medicine. Only people who have already taken part in specific earlier mezagitamab studies (TAK-079-3002 or TAK-079-1004) will be invited to participate in this follow-up study.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Takeda

Enrolment target

150

Start

14 Aug 2025

Estimated completion

29 Jul 2029

Immune Thrombocytopenic Purpura (ITP)

What is this study about?

This study is looking at a new medicine called mezagitamab for a condition known as Immune Thrombocytopenic Purpura, or ITP. If you have ITP, your body's immune system mistakenly attacks and destroys your platelets. Platelets are tiny cells in your blood that help it to clot and stop bleeding. When you have fewer platelets, you might bruise more easily or bleed for longer.

The main purpose of this study is to continue observing how safe mezagitamab is for people with ITP, and how well their bodies tolerate it when taken over a longer time. We also want to understand how effective the medicine is in managing ITP and how it works within the body.

This isn't a new study for everyone. It's a follow-up for people who have already taken part in two specific mezagitamab studies, called TAK-079-3002 or TAK-079-1004. If you were in those studies, you might be invited to join this one. You’ll only receive mezagitamab in this study if you meet specific requirements established before the study begins.

Key takeaways

This is a follow-up study for people previously in specific mezagitamab trials.
It aims to understand long-term safety and effectiveness of mezagitamab for ITP.
Participation involves regular clinic visits for health checks and blood tests.
You must be 18 years or older and meet specific health criteria to join.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be able to join this study, you must have previously completed one of two specific mezagitamab studies: TAK-079-3002 or TAK-079-1004. If you were in the TAK-079-1004 study, you must have shown a positive response to mezagitamab during that study. You must also be 18 years old or older.

There are certain reasons why you might not be able to join. For example, if you have severe allergies to certain proteins or ingredients in the mezagitamab medicine. If you were part of the TAK-079-1004 study, you might not be eligible if you've had a blood clot or a stroke in the last year, or if you had your spleen removed in the last three months. You also can't have active hepatitis B or C, or HIV.

Other reasons that might prevent you from joining include a history of cancer in the last five years (except for certain skin cancers or cervical cancer), or if your doctor believes another serious health issue could affect your participation. If you've recently had certain treatments that affect your immune system, or are taking blood-thinning medicines, this might also mean you can't join.

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 previously completed the TAK-079-3002 or TAK-079-1004 mezagitamab study.
If I was in TAK-079-1004, I showed a positive response to mezagitamab during that study.
I have not had a severe allergic reaction to mezagitamab or its ingredients.
I have not had a blood clot or stroke in the last 12 months (if from TAK-079-1004).
I do not have active hepatitis B or C, or HIV.

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive mezagitamab according to specific plans, as long as it's right for you. You will need to visit your study clinic several times during the course of the study. At these visits, the study team will carry out health checks, take blood samples, and ask about your health and how you are feeling. The study team will explain how often these visits will be. The total duration of your participation will depend on the study plan and your individual needs, but it is designed to follow your health over a longer period.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of continuing in this study is that you may continue to receive mezagitamab, which could help manage your ITP. Researchers will also closely monitor your health. All medications have potential side effects, and mezagitamab is no different. The study team will explain any known side effects and what to look out for. You will be closely monitored for any health changes. Remember, joining this study is completely your choice, and you are free to stop participating at any time, for any reason, without it affecting your medical care.

Locations (108)

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· Not yet 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· Not yet recruiting
Emory University
Verified postcode
Atlanta, United States· Not yet recruiting
The University of Iowa
Verified postcode
Iowa City, United States· Not yet recruiting
University Of Louisville Brown Cancer Center
Verified postcode
Louisville, 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· Not yet recruiting
Duke University Hospital
Verified postcode
Durham, United States· Not yet recruiting
East Carolina University
Verified postcode
Greenville, United States· Not yet recruiting
Oregon Health & Science University
Verified postcode
Portland, United States· Not yet recruiting
Perelman Center for Advanced Medicine (PCAM) Hospital of The University of Pennsylvania Penn Blood Disorders Program
Verified postcode
Philadelphia, United States· Not yet recruiting

Common questions

What is ITP?

ITP (Immune Thrombocytopenic Purpura) is a condition where your body's immune system mistakenly attacks and destroys your platelets, which are important for blood clotting.

What is mezagitamab?

Mezagitamab is the medicine being studied to see if it can help adults with ITP by managing their platelet levels.

Who can join this study?

Only adults (18+) who have already participated in one of two specific mezagitamab studies (TAK-079-3002 or TAK-079-1004) can be invited to join this follow-up study.

What's the main goal of this study?

The main goal is to find out more about how safe mezagitamab is and how well people tolerate it over a longer time for managing ITP.

Will I have to pay to be in the study?

No, you will not have to pay to receive the study medication or for study-related visits and procedures.

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.