RecruitingPHASE3INTERVENTIONAL

A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions

This study is testing a new medication called Elritercept for adults living with a blood condition called Myelodysplastic Syndromes (MDS). MDS can mean your body doesn't make enough healthy blood cells, often leading to anaemia and needing regular blood transfusions. The main goal of this study is to find out if Elritercept can help people need fewer red blood cell transfusions. Researchers also want to learn if it can reduce transfusions over longer periods or for those who need many transfusions. They will also carefully check how safe Elritercept is and if people tolerate it well. This is a Phase 3 study, meaning it's a further step in testing new treatments before they might become widely available.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Takeda

Enrolment target

225

Start

06 May 2025

Estimated completion

01 May 2032

Myelodysplastic Syndromes

What is this study about?

This research study is focused on a new medicine called Elritercept, which is being investigated as a treatment for a condition called Myelodysplastic Syndromes (MDS). MDS is a type of blood disorder where the body doesn't produce enough healthy blood cells, often leading to anaemia. Anaemia can make you feel tired and weak, and many people with MDS need regular blood transfusions to help manage these symptoms.

The main aim of this study is to see if Elritercept can reduce how often adults with certain types of MDS need to have red blood cell transfusions. This would be a significant benefit for people living with MDS. The study will also look at whether the drug can help reduce transfusions over a longer time, or for people who currently need many transfusions. On top of this, the researchers will be carefully checking for any side effects and how well people tolerate the new medicine.

This is a 'Phase 3' trial, which means it's a large study designed to confirm how well the treatment works and its safety, compared to a dummy treatment (placebo), before it might be approved for wider use. By taking part, you could contribute to important medical knowledge about living with MDS.

Key takeaways

This study is for adults with a specific type of MDS.
It aims to see if Elritercept reduces the need for red blood cell transfusions.
You will receive either the study drug or a placebo.
Treatment is given as an injection every 4 weeks.
Regular health checks and study visits will be required.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you need to be an adult (age 18 or older) with a diagnosis of Myelodysplastic Syndromes (MDS). Your MDS should be classified as 'very low, low, or intermediate risk'.

Another important requirement is that you must currently need regular red blood cell transfusions. Specifically, you would have received a certain number of transfusions within the 16 weeks before the study starts. You also need to have either not responded to previous treatments for anaemia (like ESA) or be unlikely to benefit from them.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of Myelodysplastic Syndromes (MDS)?
Do you regularly need red blood cell transfusions?
Have you not responded well to other anaemia treatments (like ESA) in the past, or are you not expected to?
Can you commit to regular study visits for several months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it's a 'double-blind' study. This means neither you nor your study doctor will know if you are receiving the active drug (Elritercept) or a dummy treatment (placebo). You will be randomly assigned to receive either Elritercept or the placebo. You'll receive your assigned treatment as an injection under the skin every four weeks.

The study will involve regular visits. Initially, you'll have visits about every two weeks. After a few months, these visits will typically become less frequent, generally every four weeks. The study has several stages. The initial treatment period lasts 24 weeks, followed by another 24-week period where you continue the same treatment. If you meet certain criteria, you might also be able to continue receiving your assigned treatment in an 'extension phase' until you choose to stop or the study ends. During these visits, the study team will monitor your health, check for any side effects, and assess your need for transfusions.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that Elritercept might reduce your need for blood transfusions or improve your anaemia. However, as it's a new medicine, there might be side effects that are not yet fully known. Some people will receive a placebo, meaning they won't get the active drug. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (179)

City of Hope
Duarte, United States· Recruiting
Los Angeles Cancer Network
Glendale, United States· Recruiting
UC San Diego Moores Cancer Center
La Jolla, United States· Recruiting
Smilow Cancer Hospital at Yale-New Haven
New Haven, United States· Recruiting
University of Miami Hospital and Clinics
Miami, United States· Recruiting
Moffitt Cancer Center
Tampa, United States· Recruiting
ILCC. Illinois Cancer Centers
Peoria, United States· Not yet recruiting
Norton Cancer Institute
Louisville, United States· Recruiting
Maryland Oncology Hematolofy
Columbia, United States· Recruiting
MidAmerica Cancer Care
Kansas City, United States· Not yet recruiting
Comprehensive Cancer Centers of Nevada
Henderson, United States· Recruiting
Northwell Health
Lake Success, United States· Not yet recruiting

+167 more sites — see the official record for the full list.

Common questions

What is Myelodysplastic Syndromes (MDS)?

MDS is a condition where your bone marrow doesn't make enough healthy blood cells, often leading to anaemia and other issues.

What is Elritercept?

Elritercept is a new medicine being tested to see if it can help people with MDS reduce their need for blood transfusions.

What does 'double-blind' mean?

It means neither you nor your doctor will know if you are getting the active study drug or a dummy treatment (placebo).

How often will I receive the treatment?

You will receive the study treatment as an injection under the skin every four weeks.

How long will I be in the study?

The initial treatment period is about 24 weeks, followed by another 24 weeks. Some participants may continue longer in an 'extension phase'.

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.