At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Elritercept (drug), Ruxolitinib (drug)
- How long the study runs
- Study runs about 98 months (dates as stated)
- About the drug or intervention
- Elritercept — drug: Elritercept SC injection. · Ruxolitinib — drug: Ruxolitinib tablet.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at a medicine called elritercept, taken either on its own or together with an existing medicine called ruxolitinib, in adults with myelofibrosis, a rare bone marrow condition. It is run by Takeda. People who take part must have anaemia (low red blood cell counts) related to their myelofibrosis.
Who can take part
- Adults aged 18 or over with a confirmed diagnosis of myelofibrosis, including myelofibrosis that developed after polycythaemia vera or essential thrombocythaemia
- Have anaemia related to myelofibrosis, shown either by needing at least 6 units of red blood cell transfusions in the past 12 weeks, or by several blood test readings showing low haemoglobin
- Reasonably well day to day (performance score of 2 or less on a standard scale) with a life expectancy of at least 12 months
- Depending on the study group: either have already tried and stopped a JAK inhibitor (a type of medicine including ruxolitinib), or already be taking a stable dose of ruxolitinib that is not fully controlling the disease. One group in Brazil includes people who have never taken a JAK inhibitor and cannot get one
- Willing and able to follow the study requirements and attend follow-up visits
- Agree to use highly effective contraception if this applies
Who may not be able to
- Serious heart problems, such as severe heart failure, certain abnormal heart rhythms, or a heart attack or unstable angina in the past 6 months
- A body mass index (BMI) of 40 or more, or uncontrolled high blood pressure
- Recent infection needing antibiotics, or a stroke, blood clot, or embolism within the past 6 months
- HIV, or active hepatitis B or C with a positive viral load
- Another cancer needing treatment within the past year, or a previous organ or blood stem cell transplant
- Anaemia caused by something other than myelofibrosis, or serious bleeding problems
- Previous treatment with luspatercept, sotatercept, or other TGF-beta inhibitors
- Recent treatment with certain blood cell growth factors, thalidomide-type medicines, interferon, hydroxycarbamide, or high-dose steroids
- Certain abnormal blood, kidney, or liver test results, such as very low or very high platelet counts, or a high number of blast cells in the blood or bone marrow
- Pregnant or breastfeeding
- Current participation in certain other studies, or recent treatment with another investigational drug for myelofibrosis or its anaemia
What taking part involves
- • Taking the study medicine, elritercept, either on its own or together with ruxolitinib — the exact way it is given is not stated — ask the trial team
- • Attending regular study visits so the team can check your health and response to treatment
Time commitment: Not stated — ask the trial team about how long the study lasts, how often visits take place, and what tests or procedures are involved.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 135
- Started
- 2021-12-16
- Last checked
- 2026-02
Plain English Summary
What is this study?
- • Testing a new treatment for myelofibrosis
- • Phase2 - 135 participants
- • The main aim of this study is to learn how safe elritercept is and how well it is tolerated when taken alone and in combination with the JAK inhibitor, ruxolitinib
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with myelofibrosis
Where?
- • Boston - United Lincolnshire Hospitals NHS Trust - Pilgrim Hospital
- • Leeds - St James Hospital,Leeds
- • London - Guys Hospital
- • London - Hammersmith Hospital
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The main aim of this study is to learn how safe elritercept is and how well it is tolerated when taken alone and in combination with the JAK inhibitor, ruxolitinib. Other aims are to learn about the effects of elritercept on the signs and symptoms of MF when taken with or without ruxolitinib and to learn how elritercept affects the body, how the body processes elritercept, and the effects of elritercept on anemia when taken with or without ruxolitinib The study will also check on how safe elritercept is and how well it is tolerated.
More detail
Elritercept is an investigational therapeutic protein designed to increase red blood cell and platelet production by inhibiting the signaling of a subset of the transforming growth factor beta (TGF-ß) family of proteins to promote hematopoiesis. It is being developed for the treatment of low blood cell counts, or cytopenias including anemia and thrombocytopenia in participants with Myelodysplastic Syndrome (MDS) and Myelofibrosis (MF).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ discontinued JAK inhibitor therapy ≥8 weeks
- ✓ JAK inhibit
What the study is looking for
- ✓In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the...
- ✓Male or female greater than equal to (≥)18 years of age, at the time of signing agreement to take part.
- ✓activity scale (ECOG) performance score lesser than equal to (≤)2.
- ✓Life expectancy ≥12 months per Investigator assessment.
- ✓Anemia, defined as:
Who cannot take part
- ✗Medical History:
- ✗Presence of the following heart conditions:
- ✗New York Heart Association Class 3 or 4 heart failure
- ✗QTcF (QT interval corrected by Fridericia's formula) \>500 milliseconds (msec) on the screening or C1D1...
- ✗Uncontrolled clinically significant arrhythmia (participants with rate-controlled atrial fibrillation are not excluded)
See the full criteria
Where Is This Study? (5 UK sites)
United Lincolnshire Hospitals NHS Trust - Pilgrim Hospital
Boston, United Kingdom
St James Hospital,Leeds
Leeds, United Kingdom
Guys Hospital
London, United Kingdom
Hammersmith Hospital
London, United Kingdom
University College London
London, United Kingdom
How to Get in Touch
Takeda Contact
Sponsor contactCONTACT
