RecruitingPHASE2INTERVENTIONAL

A Study of Elritercept Alone or Together With Ruxolitinib in Adults With Myelofibrosis

This study is investigating a new medication called Elritercept, designed to help people with myelofibrosis. Myelofibrosis is a condition where scar tissue builds up in the bone marrow, affecting blood cell production. The main goal is to understand how safe Elritercept is and how well the body tolerates it, both on its own and when given with an existing medicine called Ruxolitinib. Researchers are also keen to observe if Elritercept can reduce symptoms of myelofibrosis, such as tiredness due to low red blood cells (anaemia). They will study how the medicine works in the body and its overall effects on blood counts. This is a Phase 2 study, meaning it's still in the earlier stages of human testing, focusing on safety and initial effectiveness.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Takeda

Enrolment target

135

Start

16 Dec 2021

Estimated completion

28 Feb 2030

Myelofibrosis

What is this study about?

This research study is focused on a health condition called myelofibrosis. In this condition, the bone marrow, which is like the body's blood-making factory, gets scarred. This scarring makes it hard for the bone marrow to produce enough healthy blood cells, leading to problems like tiredness (due to too few red blood cells), bleeding issues, and infections.

The study is testing a new medicine called Elritercept. This medicine is designed to help the bone marrow make more red blood cells and other important blood cells. Researchers want to see if Elritercept is safe and if it helps people feel better. They're trying it out in two ways: some people will take Elritercept on its own, and others will take it alongside another medicine already used for myelofibrosis, called Ruxolitinib. This will help them understand how the new medicine works by itself and if it's even better when combined with another treatment.

Beyond safety, the study will also look at how Elritercept affects the common symptoms of myelofibrosis. They will monitor things like how tired people feel, their blood counts, and how the medicine moves through and is used by the body. This information is crucial for understanding if Elritercept could be a helpful new treatment option for people living with myelofibrosis.

Key takeaways

This study is testing a new medicine called Elritercept for myelofibrosis.
It aims to check the safety and how well Elritercept is handled by the body.
Some people will take Elritercept alone, others with Ruxolitinib.
Researchers will look at how it affects symptoms like anaemia and blood counts.
You must have a confirmed diagnosis of myelofibrosis and anaemia to be eligible.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old, and understand what the study involves and agree to take part. You should also be generally well enough to participate in a clinical trial, as assessed by the study doctor.

You must have a confirmed diagnosis of myelofibrosis. This includes primary myelofibrosis, or myelofibrosis that developed after having polycythemia vera or essential thrombocythemia. A key part of joining is also having anaemia, meaning you have low red blood cell counts. This anaemia is defined by either needing regular blood transfusions or having consistently low haemoglobin levels.

It's important that you or your doctor believe you can follow the study's requirements, like attending appointments. The study team will review all your medical information to make sure you meet all the necessary criteria. You will not be able to participate if you do not meet these specific requirements.

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.

Are you 18 years old or older?
Do you have a confirmed diagnosis of myelofibrosis (PMF, PV MF, or ET MF)?
Do you have anaemia (low red blood cell count), either needing transfusions or consistently low haemoglobin?
Are you generally well enough to participate in a study, as assessed by a doctor?
Are you able and willing to attend all study appointments and follow instructions?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given either Elritercept alone or Elritercept with Ruxolitinib. The study will involve regular visits to the clinic where you'll have check-ups, blood tests, and other assessments to monitor your health and how the medicine is affecting you. These visits will help the researchers understand how safe the treatment is and if it's helping with your myelofibrosis symptoms. You'll be asked questions about your health and any side effects you might experience. The total duration of your participation will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial means you might be among the first to try a new treatment that could potentially help your condition, although there's no guarantee. Researchers will closely monitor your health throughout the study. However, like all medicines, Elritercept may have side effects, and some might not be known yet. You will be fully informed about all known risks before deciding to join. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (46)

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

Concord Hospital
Verified postcode
Concord, Australia· Recruiting
The Tweed Hospital
Verified postcode
Tweed Heads, Australia· Recruiting
Flinders Medical Centre
Verified postcode
Woodville South, Australia· Recruiting
St. Vincents Hospital Melbourne
Verified postcode
Fitzroy, Australia· Recruiting
Royal Melbourne Hospital
Verified postcode
Melbourne, Australia· Recruiting
Ballarat Oncology & Haematology Service
Verified postcode
Wendouree, Australia· Recruiting
Hospital de Clinicas de Porto Alegre
Verified postcode
Porto Alegre, Brazil· Recruiting
IMV-Pesquisa Cardiologica Sociedade Simples
Verified postcode
Porto Alegre, Brazil· Recruiting
Albert Einstein Sociedade Beneficente Israelita Brasiliera
Verified postcode
São Paulo, Brazil· Recruiting
Hospital Beneficencia Portuguesa de Sao Paulo
Verified postcode
São Paulo, Brazil· Recruiting
Hospital Das Clinicas Da Faculdade de Medicina Da U S P
Verified postcode
São Paulo, Brazil· Recruiting
Instituto de Ensino e Pesquisas Sao Lucas
Verified postcode
São Paulo, Brazil· Recruiting

Common questions

What is myelofibrosis?

Myelofibrosis is a condition where scarring develops in the bone marrow, making it difficult for the body to produce enough healthy blood cells.

What is Elritercept?

Elritercept is a new investigational medicine being tested in this study. It's designed to help your body make more red blood cells and other important blood cells.

What is Ruxolitinib?

Ruxolitinib is a medicine already used to treat myelofibrosis. In this study, some people will take Elritercept along with Ruxolitinib.

Will I definitely get the new medicine?

Yes, everyone in this study will receive the new medicine, Elritercept, either on its own or together with Ruxolitinib.

What 'phase' is this study?

This is a 'Phase 2' study. This means researchers are mainly looking at how safe the medicine is and how well it's tolerated, as well as getting an idea of its effectiveness.

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.