Actively Recruiting
A Phase 2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Elritercept Alone or With Ruxolitinib in Adults With Myelofibrosis
Led by Takeda · Updated on 2026-02-05
135
Participants Needed
46
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of an investigational drug called elritercept, both alone and in combination with the JAK inhibitor ruxolitinib, in adults with myelofibrosis (MF). The study also aims to understand how elritercept affects the signs and symptoms of MF, how the body processes the drug, and its effects on anemia when used with or without ruxolitinib. This is a Phase 2 open-label study focusing on participants with anemia related to MF.
CONDITIONS
Brief 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 the study 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 12 months or longer as assessed by Investigator
- Confirmed diagnosis of primary, post-polycythemia vera, or post-essential thrombocythemia myelofibrosis per specified criteria
- Anemia defined by red blood cell transfusion history or hemoglobin levels as specified
- Arm-specific criteria related to prior JAK inhibitor treatment or current ruxolitinib use
- Agreement to use effective contraception if applicable
You will not qualify if you...
- Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 14 days before treatment
- Certain heart conditions including severe heart failure, serious arrhythmias, recent heart attack, or unstable angina
- Body mass index of 40 kg/m² or higher
- Uncontrolled high blood pressure despite treatment
- History of drug or alcohol abuse within last 2 years
- Recent stroke, deep vein thrombosis, or arterial embolism within 6 months
- Major surgery within 28 days before treatment
- Known positive HIV or active hepatitis B or C infection
- Recent or active malignancies other than specified myelofibrosis types
- History of organ transplantation
- Allergic reactions to study drugs
- Certain blood disorders causing anemia
- Recent significant bleeding events
- Recent transfusions unrelated to myelofibrosis
- Prior treatment with similar investigational drugs
- Recent use of certain medications or therapies as specified
- Abnormal laboratory values outside defined limits
- Pregnant or breastfeeding females
- Other conditions that may prevent participation as judged by Investigator or Sponsor
- Study staff and immediate family members involved in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 52 weeks
Participants receive escalating doses of elritercept alone or in combination with ruxolitinib every 4 weeks for up to 13 cycles, totaling approximately 52 weeks of treatment.
13 visits (in-person, every 4 weeks)
Duration - Variable, until commercial availability or discontinuation
Participants benefiting from elritercept treatment can continue receiving the drug until it becomes commercially available or is no longer in development for myelofibrosis.
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
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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