A Phase 3, Double-Blind, Randomized Trial Evaluating the Efficacy and Safety of Elritercept (TAK‑226) Compared to Placebo in Participants With Myelofibrosis and Anemia on Concurrent Ruxolitinib Therapy
Myelofibrosis is an uncommon blood cancer that causes scarring in the bone marrow. This scarring makes it difficult for the body to make enough healthy red blood cells, leading to severe anaemia and extreme tiredness. Many people rely on frequent blood transfusions to cope with their symptoms. This Phase 3 clinical trial is testing a new medicine called elritercept alongside standard treatment (ruxolitinib, also called Jakavi). The main aim is to find out if elritercept can help patients go without blood transfusions for at least 12 weeks. Participants will receive either elritercept or a dummy medicine (placebo), taken together with their regular ruxolitinib tablets. Researchers will monitor whether the new treatment helps boost red blood cell levels, reduces severe fatigue, and improves day-to-day quality of life. This trial will help doctors understand if elritercept is safe and effective.
At a glance
What is this study about?
Inside our bones is spongy tissue called bone marrow, which produces healthy blood cells. In myelofibrosis, the bone marrow becomes scarred and cannot make enough red blood cells. Red blood cells carry oxygen around the body, so having too few of them (a condition called anaemia) leaves people feeling exhausted, weak, and short of breath. Many patients need regular blood transfusions at the hospital to top up their blood levels.
Many people with myelofibrosis take a standard tablet called ruxolitinib (Jakavi) to ease symptoms like an enlarged spleen, night sweats, and bone pain. While ruxolitinib is helpful, it does not always fix anaemia and can sometimes make it worse. This clinical trial is testing whether adding an investigational drug called elritercept can help the body produce more red blood cells on its own.
This is a Phase 3 study, which means it tests the medicine in a larger group of people to confirm how well it works. Half of the participants will receive elritercept, and the other half will receive a placebo (an inactive dummy treatment). Both groups will continue taking their regular ruxolitinib tablets. To keep the test fair, neither you nor your doctor will know which treatment you are receiving until the trial is complete.
The findings from this study could be very important. If elritercept works, it could help people with myelofibrosis depend less on hospital blood transfusions, giving them more energy and independence in their daily lives.
Key takeaways
- A Phase 3 study testing a new medicine called elritercept for people with myelofibrosis and anaemia.
- Open to adults aged 18 and older who are already taking ruxolitinib (Jakavi).
- Aims to reduce or eliminate the need for regular hospital blood transfusions.
- Compares the study drug against an inactive dummy treatment (placebo).
- Tracks improvements in daily tiredness and overall quality of life.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with myelofibrosis and have anaemia. To be considered, you must already be taking ruxolitinib (Jakavi) as part of your regular treatment.
You will need to have low red blood cell counts or need regular blood transfusions to manage your anaemia. The trial team will look closely at your recent blood test records and transfusion history to see if you meet the specific criteria.
Because safety is the top priority, the study may not be suitable for people with certain other serious health issues, such as severe heart, liver, or kidney problems. The hospital study team will carry out a thorough health check before you can 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 aged 18 or older.
- I have been diagnosed with myelofibrosis.
- I have anaemia or receive regular blood transfusions.
- I am currently taking ruxolitinib (Jakavi).
- I am willing and able to attend regular clinic visits over several months.
What does participation involve?
If you decide to take part, you will continue taking your prescribed ruxolitinib tablets each day. You will also receive either elritercept or the matching placebo. The main treatment period lasts for about 36 weeks (around 9 months). During this time, you will visit the hospital clinic regularly for routine check-ups. These visits will include blood tests, physical examinations, and short questionnaires asking about your energy levels and quality of life. You will also keep track of any blood transfusions you receive. After the main 36-week period, the medical team will keep in touch to monitor your long-term health and wellbeing.
Potential risks and benefits
Locations (10)
- —UnverifiedItaly
- —UnverifiedAustria
- —UnverifiedGreece
- —UnverifiedSweden
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedFrance
- —UnverifiedRomania
Common questions
What is a placebo?
A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps doctors see if changes in health are truly caused by the new medicine.
Will I have to stop taking my usual ruxolitinib tablets?
No. Everyone in this study continues to take their regular ruxolitinib (Jakavi) tablets as prescribed by their doctor.
Can I still have a blood transfusion if I need one during the trial?
Yes. Your safety and comfort come first. If your red blood cell levels drop and your doctor decides you need a transfusion, you will receive one.
How long will I be in the study?
The main treatment phase lasts for 36 weeks (about 9 months), followed by a period of health check-ups to monitor your progress.
Do I have to pay to take part in this clinical trial?
No. The study medication and all trial-related tests are provided free of charge, and travel expenses for hospital visits are often reimbursed.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.