A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
This study is investigating a new medication called elritercept. It's for adults who have myelofibrosis (a bone marrow condition) and anaemia, and are currently taking another drug called ruxolitinib. The main goal is to find out if elritercept can help improve their anaemia compared to a dummy pill (placebo). Researchers also want to see if elritercept can reduce tiredness, make other myelofibrosis symptoms better, and help people be more active. They'll also check how it affects bone marrow and the spleen, and look at its overall safety. Participants will receive treatment for at least nine months, and those on the dummy pill may switch to elritercept afterwards.
At a glance
What is this study about?
You might be interested in this study if you have myelofibrosis and anaemia and are already taking ruxolitinib. Myelofibrosis is a condition where your bone marrow doesn't work properly and is replaced by scar tissue, which can lead to low red blood cell counts, known as anaemia. Anaemia can make you feel very tired and have less energy. Ruxolitinib is a common treatment for myelofibrosis, but sometimes people still experience anaemia.
The main purpose of this study is to see if a new drug, elritercept, can help improve anaemia in people like you. Researchers will compare elritercept to a 'placebo', which is a dummy drug that looks like elritercept but has no active ingredients. This helps them understand if any changes are truly due to the study drug. They'll be looking at things like your red blood cell count, how you feel day-to-day, and if you have more energy.
The study also aims to understand how elritercept affects other aspects of your health, such as tiredness, overall myelofibrosis symptoms, and your ability to do physical activities. Researchers will also check how the drug affects your bone marrow and spleen, and whether your body makes antibodies against the drug. Your safety is a top priority, so they will carefully monitor for any side effects and see if elritercept remains safe over a longer period.
Key takeaways
- This study is for adults with myelofibrosis and anaemia already on ruxolitinib.
- It tests a new drug called elritercept against a dummy drug (placebo).
- The main goal is to see if elritercept improves anaemia and other symptoms.
- Safety is a priority, with careful monitoring for side effects.
- Participation involves at least nine months of treatment and regular check-ups.
- You can stop participating at any time if you wish.
Who may be eligible?
To join this study, you need to be at least 18 years old and understand what the study involves. You must have a confirmed diagnosis of myelofibrosis (either primary myelofibrosis, or developed after essential thrombocythemia or polycythemia vera). A key part of eligibility is that you need to have anaemia that has required blood transfusions in the three months before starting the study (specifically, 3 to 8 units of red blood cells).
You also need to have been taking ruxolitinib as your usual myelofibrosis treatment for at least 12 weeks, and been on a stable dose (meaning it hasn't changed) for at least 8 weeks before the study starts. You should also be generally well enough to participate in the study, as assessed by a doctor, meaning you don't have severe limitations on your daily activities.
There are also some reasons why you might not be able to join. For example, if you've recently taken certain other medications for your condition or other illnesses, such as luspatercept or sotatercept, or certain types of steroids or other blood-boosting drugs. Your doctor will carefully review all your current and recent medications to make sure it's safe for you to participate.
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 diagnosis of myelofibrosis?
- Do you have anaemia and have needed 3-8 blood transfusions in the last 3 months?
- Are you currently taking ruxolitinib for your myelofibrosis?
- Have you been on a stable dose of ruxolitinib for at least the last 8 weeks?
- Have you avoided certain other specific medications in the last month?
What does participation involve?
If you decide to join this study, you'll be given either the study drug, elritercept, or a placebo (dummy drug). Neither you nor your study doctor will know which one you are receiving at first. You'll take the study treatment for at least nine months (about 36 weeks). During this time, you will have regular clinic visits where the study team will monitor your health, check your blood, and ask about your symptoms and how you are feeling. They will also assess changes in your bone marrow and spleen.
After this initial nine-month period, if you were on the placebo, you'll have the option to switch and start taking elritercept. The total duration of your participation, including follow-up visits, will be explained in detail by the study team. You'll have ongoing support and monitoring throughout your time in the study.
Potential risks and benefits
Locations (194)
- Los Angeles Cancer NetworkVerified postcodeGlendale, United States· Not yet recruiting
- Cancer and Blood Specialty ClinicVerified postcodeWhittier, United States· Not yet recruiting
- MedStar Georgetown University HospitalVerified postcodeWashington D.C., United States· Not yet recruiting
- Advanced Research, LLCVerified postcodeCoral Springs, United States· Not yet recruiting
- Bioresearch PartnersVerified postcodeMiami, United States· Not yet recruiting
- AdventHealth - Cancer Institute - OrlandoVerified postcodeOrlando, United States· Not yet recruiting
- Florida Clinical Trials GroupVerified postcodeTamarac, United States· Not yet recruiting
- Moffit Cancer CenterVerified postcodeTampa, United States· Not yet recruiting
- Emory UniversityVerified postcodeAtlanta, United States· Not yet recruiting
- Tufts Medical CenterVerified postcodeBoston, United States· Not yet recruiting
- Washington University School of MedicineVerified postcodeSt Louis, United States· Not yet recruiting
- St. Vincent Regional Hospital Cancer CentersVerified postcodeBillings, United States· Not yet recruiting
Common questions
What is myelofibrosis?
Myelofibrosis is a rare bone marrow condition where scar tissue builds up, making it harder for your body to produce healthy blood cells.
What is anaemia?
Anaemia means you have a low number of red blood cells, which carry oxygen. This can make you feel very tired and short of breath.
What is a placebo?
A placebo is a 'dummy' treatment that looks like the real drug but contains no active medicine. It helps researchers compare the effects of the new drug.
How long will I be in the study?
You'll receive the study treatment for at least 9 months (36 weeks), with continued monitoring afterwards. The full duration will be discussed with you.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your future medical care.
How to find out more
Takeda Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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