Actively Recruiting
A Study of Elritercept Alone or Together With Ruxolitinib in Adults With Myelofibrosis
Led by Takeda · Updated on 2026-02-05
135
Participants Needed
46
Research Sites
428 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Elritercept Alone or Together With Ruxolitinib in Adults With Myelofibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand study purpose and risks and provide signed informed consent
- Willing and able to follow study procedures and attend visits
- Male or female aged 18 years or older at consent
- Eastern Cooperative Oncology Group (ECOG) performance score of 2 or less
- Life expectancy of at least 12 months as assessed by Investigator
- Confirmed diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis
- Anemia requiring red blood cell transfusions or with low hemoglobin measurements as defined
- For Arms 1A and 2A: Previously treated with JAK inhibitors and discontinued for specified reasons, with at least 8 weeks since last JAK inhibitor dose
- For Arms 1B and 2B: Receiving ruxolitinib for at least 8 weeks and stable dose for 4 weeks, meeting specific disease criteria
- For Arm 2C (Brazil only): No prior JAK inhibitor treatment and no access to such therapy, with specified spleen volume or symptom scores
- Females of childbearing potential and sexually active males agree to use effective contraception
You will not qualify if you...
- Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 14 days prior to treatment
- Severe heart conditions including New York Heart Association Class 3 or 4 heart failure, certain arrhythmias, recent heart attack or unstable angina
- Body mass index of 40 kg/m2 or higher
- Uncontrolled hypertension despite treatment
- History of drug or alcohol abuse within past 2 years
- History of stroke, deep vein thrombosis, or arterial embolism within 6 months
- Major surgery within 28 days prior to treatment
- Known positive HIV, active hepatitis B or C infection with viral load
- Recent or ongoing malignancies other than specified myelofibrosis types
- History of organ or blood stem cell transplantation
- Severe allergic reactions to study drugs or components
- Hemolytic anemia, active bleeding, certain blood disorders causing anemia
- Recent intracranial hemorrhage or significant bleeding events
- Recent transfusions unrelated to myelofibrosis
- Prior treatment with certain TGF-beta inhibitors
- Recent use of specific blood growth factors, immunomodulators, interferon, hydroxyurea, or high-dose steroids
- Recent new iron chelation or vitamin B12/folate therapies
- Use of other investigational or approved therapies for myelofibrosis or anemia within specified timeframes
- Recent use of strong CYP3A4 inhibitors in participants receiving ruxolitinib
- Laboratory abnormalities including high bone marrow blasts, abnormal blood counts, low iron or vitamins, poor kidney function, or abnormal liver tests
- Pregnant or breastfeeding females
- Any condition deemed by Investigator or Sponsor to prevent study participation
- Investigational site staff or immediate family members involved in the study or related organizations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 46 locations
1
Concord Hospital
Concord, New South Wales, Australia
Actively Recruiting
2
The Tweed Hospital
Tweed Heads, New South Wales, Australia, 2485
Actively Recruiting
3
Flinders Medical Centre
Woodville South, South Australia, Australia, 5042
Actively Recruiting
4
St. Vincents Hospital Melbourne
Fitzroy, Victoria, Australia, 3355
Actively Recruiting
5
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Actively Recruiting
6
Ballarat Oncology & Haematology Service
Wendouree, Victoria, Australia, 3355
Actively Recruiting
7
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
Actively Recruiting
8
IMV-Pesquisa Cardiologica Sociedade Simples
Porto Alegre, Brazil
Actively Recruiting
9
Albert Einstein Sociedade Beneficente Israelita Brasiliera
São Paulo, Brazil
Actively Recruiting
10
Hospital Beneficencia Portuguesa de Sao Paulo
São Paulo, Brazil
Actively Recruiting
11
Hospital Das Clinicas Da Faculdade de Medicina Da U S P
São Paulo, Brazil
Actively Recruiting
12
Instituto de Ensino e Pesquisas Sao Lucas
São Paulo, Brazil
Actively Recruiting
13
CHU Amiens - Hopital Sud
Amiens, France
Completed
14
Hopital Morvan
Brest, France
Completed
15
Hopital Prive Sevigne
Cesson-Sévigné, France
Completed
16
Centre Hospitalier Lyon Sud
Lyon, France
Actively Recruiting
17
Institut de Cancerologie du Gard
Nîmes, France
Actively Recruiting
18
Hopital de la Source - CHR Orleans
Orléans, France
Completed
19
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Italy
Actively Recruiting
20
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, Italy
Actively Recruiting
21
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, Italy
Actively Recruiting
22
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Actively Recruiting
23
Ospedale Policlinico San Martino
Genova, Italy
Actively Recruiting
24
ASST Grande Ospedale Metropolitano Niguarda, Niguarda Cancer Center
Milan, Italy
Actively Recruiting
25
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, Italy
Actively Recruiting
26
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Milan, Italy
Completed
27
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
Reggio Emilia, Italy
Actively Recruiting
28
Azienda Ospedaliera Universitaria Policlinico Umberto I
Roma, Italy
Actively Recruiting
29
Azienda Socio Sanitaria Territoriale Sette Laghi
Varese, Italy
Actively Recruiting
30
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
Actively Recruiting
31
Gachon University Gil Medical Center
Incheon, South Korea
Completed
32
Samsung Medical Center
Seoul, South Korea
Completed
33
Seoul St. Marys Hospital, The Catholic University of Korea
Seoul, South Korea
Actively Recruiting
34
Soonchunhyang University Seoul Hospital
Seoul, South Korea
Actively Recruiting
35
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Actively Recruiting
36
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Actively Recruiting
37
Hospital Universitario La Paz
Madrid, Spain
Actively Recruiting
38
Hospital Universitario La Princesa
Madrid, Spain
Actively Recruiting
39
Hospital Universitario de Salamanca
Salamanca, Spain
Actively Recruiting
40
Hospital Clinico Universitario de Valencia
Valencia, Spain
Actively Recruiting
41
Hospital QuironSalud de Zaragoza
Zaragoza, Spain
Actively Recruiting
42
United Lincolnshire Hospitals NHS Trust - Pilgrim Hospital
Boston, United Kingdom
Actively Recruiting
43
St James Hospital,Leeds
Leeds, United Kingdom
Actively Recruiting
44
Guys Hospital
London, United Kingdom
Actively Recruiting
45
Hammersmith Hospital
London, United Kingdom
Actively Recruiting
46
University College London
London, United Kingdom
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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