A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions
This research study is investigating a new medication called Elritercept. It's for adults who have a specific blood disorder known as myelodysplastic syndromes (MDS) and currently need regular red blood cell transfusions. The study aims to compare Elritercept with a common existing treatment, Epoetin Alfa, to see which is more effective and safer at reducing the need for these transfusions. Specifically, researchers want to find out if Elritercept can help people go for at least 12 weeks without needing a transfusion, and if it also increases their blood's haemoglobin levels. This is a large-scale study, which is an important step in understanding if Elritercept could be a new treatment option for MDS.
At a glance
What is this study about?
This study is for people who have a blood condition called myelodysplastic syndromes, or MDS. With MDS, your bone marrow doesn't make enough healthy blood cells. This can lead to anaemia, which means you don't have enough red blood cells to carry oxygen around your body, making you feel tired and weak. Many people with MDS need regular blood transfusions to help with these symptoms.
The study is testing a new medicine called Elritercept. Researchers want to see how well it works compared to a standard treatment called Epoetin Alfa. Both medicines aim to help your body produce more red blood cells, potentially reducing the need for transfusions. The main goal is to find out if Elritercept can help people go for a longer time without needing a blood transfusion, and if it can also boost the amount of haemoglobin (the oxygen-carrying part of red blood cells) in their blood.
This type of study is called a 'Phase 3' trial. This means it's a large study, and if Elritercept proves to be safe and more effective, it could become a new treatment option for people living with MDS. The results will help doctors understand the best ways to manage anaemia in people with this condition and improve their quality of life.
Key takeaways
- The study is testing a new medicine for myelodysplastic syndromes (MDS).
- It aims to reduce the need for blood transfusions.
- The new medicine, Elritercept, is being compared to standard treatment, Epoetin Alfa.
- Participants will know which treatment they are receiving.
- The main goal is to see if Elritercept can help improve blood counts and reduce transfusions over 24 weeks.
- This is a Phase 3 study, a crucial step for potential new treatments.
Who may be eligible?
To join this study, you must be an adult, aged 18 or older. Both men and women are welcome to take part.
You need to have been diagnosed with a specific type of myelodysplastic syndrome (MDS) that doctors consider to be 'very low', 'low', or 'intermediate' risk. A healthcare professional will be able to tell you if your MDS falls into these categories.
A key requirement is that you are currently needing regular red blood cell transfusions. Also, you should not have received certain types of anaemia treatment (called ESA-naïve) before joining the study. Your doctor will be able to check all these details to see if you might be a good fit.
- Are you 18 years old or older?
- Have you been diagnosed with myelodysplastic syndromes (MDS)?
- Do you currently need regular red blood cell transfusions?
- Has your doctor told you your MDS is 'very low', 'low', or 'intermediate' risk?
- Have you NOT received certain anaemia treatments (ESAs) before for your MDS?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
As a participant in this study, you would be randomly assigned to receive either the new medicine, Elritercept, or the standard treatment, Epoetin Alfa. This means you wouldn't get to choose which one you receive, similar to flipping a coin, to ensure a fair comparison. The study is 'open-label', which means both you and your study doctor will know which treatment you are receiving.
You would have regular visits to the clinic for medical check-ups, blood tests, and to receive your study medication. These visits would be important for monitoring your health, checking how well the treatment is working, and looking for any side effects. The main focus of the study is to see if your need for red blood cell transfusions decreases and if your haemoglobin levels improve over the first 24 weeks of treatment.
Potential risks and benefits
Locations (14)
- —France
- —Belgium
- —Germany
- —Italy
- —Bulgaria
- —Ireland
- —Lithuania
- —Norway
- —Romania
- —Hungary
- —Spain
- —Greece
+2 more sites — see the official record for the full list.
Common questions
What are myelodysplastic syndromes (MDS)?
MDS is a condition where your bone marrow doesn't make enough healthy blood cells. This can lead to problems like anaemia, where you don't have enough red blood cells.
What is anaemia?
Anaemia means your blood has a lower than usual number of red blood cells, or not enough haemoglobin, which can make you feel tired and out of breath.
What does 'red blood cell transfusion' mean?
It's a medical procedure where you receive healthy red blood cells from a donor to increase the number of red blood cells in your own blood.
What does a 'Phase 3' study mean?
A Phase 3 study is a large research trial that compares a new treatment to existing ones to confirm its safety and effectiveness on a bigger group of people.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, which means both you and the study doctor will know whether you are receiving Elritercept or Epoetin Alfa.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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