A Study of Elritercept Alone or Together With Ruxolitinib in Adults With Myelofibrosis

Recruiting now · Phase 2

Conditions studied: Myelofibrosis

In brief

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.

Key facts

Study ID

NCT05037760

Run by

Takeda

People needed

135

Starts

2021-12-16

Expected to finish

2030-02-28

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local study participant privacy regulations.
• In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the protocol (e.g., all study procedures, return for follow-up visits).
• Male or female greater than equal to (≥)18 years of age, at the time of signing informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance score lesser than equal to (≤)2.
• Life expectancy ≥12 months per Investigator assessment.
• Confirmed diagnosis of primary myelofibrosis (PMF) (prefibrotic or overtly fibrotic) according to the 2016 World Health Organization (WHO) criteria, post-polycythemia vera myelofibrosis (PV MF), or post-essential thrombocythemia myelofibrosis (ET MF) according to the 2008 International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria.
• Anemia, defined as:
• Having received ≥6 units of RBC transfusion for Hgb ≤8.5 g/dL in the 12 weeks prior to the planned C1D1, including ≥1 unit of RBC transfusion in the 28 days prior to C1D1; or
• Having ≥3 evaluable Hgb measurements at less than (<)10.0 g/dL including ≥1 evaluable Hgb measurement assessed 8 to 13 weeks prior to C1D1. Participants receiving RBC transfusions but not meeting criterion "a." may enroll under criterion "b." following the below parameters:
• All pre-transfusion Hgb values (defined as a Hgb assessed within the 3 days prior to a transfusion) should be recorded, and ≥1 pre-transfusion Hgb value is required.
• Hgb values collected within the 28 days following a transfusion will not be considered evaluable unless qualifying as a pre-transfusion Hgb; in cases where multiple transfusions are given in succession due to poor Hgb response, only the first pre-transfusion Hgb will be considered evaluable.
• Arm-specific criteria:
• Arms 1A and 2A:
• Previously treated with JAK inhibitor(s) and, per the Investigator, discontinued due to one of the following reasons:
• Relapsed disease following treatment with JAK inhibitor(s)
• Refractory to treatment with JAK inhibitor(s)
• Intolerance to treatment with JAK inhibitor(s)
• Participant no longer met risk/benefit ratio to continue JAK inhibitor(s) OR
• Participant with prognostic score of intermediate-1 or higher per Dynamic International Prognostic Scoring System (DIPSS) and is ineligible for JAK inhibitor(s) in the opinion of the Investigator
• Participants previously treated with JAK inhibitor(s) must have discontinued JAK inhibitor therapy ≥8 weeks before C1D1
• Arms 1B and 2B:
• Has been receiving ruxolitinib prescribed for a diagnosis of PMF (prefibrotic or overtly fibrotic), post-PV MF, or post-ET MF for ≥8 weeks prior to C1D1 and on a stable dose for ≥4 weeks prior to C1D1. In Arm 2B only, at least 10 participants should have been on ruxolitinib for <6 months prior to C1D1.
• Meets ≥1 of the following criteria in the opinion of the Investigator:
• Current ruxolitinib treatment is considered to be providing insufficient control of the disease
• The participant's cytopenias are limiting the participant's ruxolitinib dose intensity

You may not qualify if…

• Medical History:
• Active infection requiring parenteral antibiotic therapy within 28 days prior to C1D1 or oral antibiotics within 14 days of C1D1. Prophylactic antibiotics and/or antifungals for neutropenia are allowed.
• Presence of the following cardiac 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 electrocardiogram (ECG; mean of 3 measurements)
• Uncontrolled clinically significant arrhythmia (participants with rate-controlled atrial fibrillation are not excluded)
• Acute myocardial infarction or unstable angina pectoris ≤6 months prior to C1D1
• Body mass index (BMI) ≥40 kilograms per meter square (kg/m\^2).
• Presence of uncontrolled hypertension, defined as systolic blood pressure ≥160 millimeters of mercury (mmHg) or diastolic blood pressure ≥100 mmHg despite adequate treatment.
• History of drug or alcohol abuse (as defined by the Investigator) within the past 2 years.
• History of stroke, deep venous thrombosis, or arterial embolism within 6 months prior to C1D1.
• Major surgery within 28 days prior to C1D1. Participants must have completely recovered from any previous surgery prior to C1D1 in the opinion of the Investigator.
• Known positive for human immunodeficiency virus (HIV), active infectious hepatitis B with positive viral load (hepatitis B virus [HBV] deoxyribonucleic acid [DNA]), or active infectious hepatitis C with positive viral load (hepatitis C virus [HCV] ribonucleic acid [RNA]). Participants without a known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.
• Any malignancy other than PMF, post-ET MF, or post-PV MF that has not been in remission and/or has required systemic therapy including radiation, chemotherapy, hormonal therapy, or biologic therapy, within 1 year prior to C1D1. In situ cancers, squamous cell and basal cell carcinomas, and monoclonal gammopathy of unclear significance are allowed at the discretion of the Investigator.
• History of solid organ or hematological transplantation.
• History of severe allergic or anaphylactic reaction(s) or hypersensitivity to recombinant proteins or excipients in the investigational drug, or ruxolitinib for participants enrolling in Arm 1B or 2B.
• Diagnosis of hemolytic anemia, active bleeding, hemoglobinopathies, or congenital disorders as a cause of the participant's anemia.
• History of intracranial hemorrhage (any grade).
• National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 bleeding events within the 3 months prior to C1D1.
• Receipt of an RBC or platelet transfusion for any reason(s) or combination of reasons other than underlying MF within the 12 weeks prior to C1D1. If a participant requires a transfusion for an unanticipated reason during the Pretreatment Period, a prolonged screening period may be considered after discussion with the Medical Monitor.
• Treatment History:
• Prior treatment with luspatercept, sotatercept, or other commercially available or investigational transforming growth factor-beta (TGF-β) inhibitors (all arms).
• Treatment within 28 days prior to C1D1 with:
• Erythropoiesis-stimulating agent (ESA)
• Granulocyte colony-stimulating factor (G-CSF)

Where it is running

• University College London — London, United Kingdom (enrolling)
• The Tweed Hospital — Tweed Heads, New South Wales, Australia (enrolling)
• Flinders Medical Centre — Woodville South, South Australia, Australia (enrolling)
• St. Vincents Hospital Melbourne — Fitzroy, Victoria, Australia (enrolling)
• Royal Melbourne Hospital — Melbourne, Victoria, Australia (enrolling)
• Ballarat Oncology & Haematology Service — Wendouree, Victoria, Australia (enrolling)
• Hospital de Clinicas de Porto Alegre — Porto Alegre, Brazil (enrolling)
• IMV-Pesquisa Cardiologica Sociedade Simples — Porto Alegre, Brazil (enrolling)
• Albert Einstein Sociedade Beneficente Israelita Brasiliera — São Paulo, Brazil (enrolling)
• Hospital Beneficencia Portuguesa de Sao Paulo — São Paulo, Brazil (enrolling)
• Hospital Das Clinicas Da Faculdade de Medicina Da U S P — São Paulo, Brazil (enrolling)
• Instituto de Ensino e Pesquisas Sao Lucas — São Paulo, Brazil (enrolling)
• Hospital Clinico Universitario de Valencia — Valencia, Spain (enrolling)
• Hospital QuironSalud de Zaragoza — Zaragoza, Spain (enrolling)
• United Lincolnshire Hospitals NHS Trust - Pilgrim Hospital — Boston, United Kingdom (enrolling)
• St James Hospital,Leeds — Leeds, United Kingdom (enrolling)
• Guys Hospital — London, United Kingdom (enrolling)
• Hammersmith Hospital — London, United Kingdom (enrolling)
• Concord Hospital — Concord, New South Wales, Australia (enrolling)
• Centre Hospitalier Lyon Sud — Lyon, France (enrolling)
• Institut de Cancerologie du Gard — Nîmes, France (enrolling)
• Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari — Bari, Italy (enrolling)
• Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi — Bologna, Italy (enrolling)
• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia — Brescia, Italy (enrolling)
• Azienda Ospedaliera Universitaria Careggi — Florence, Italy (enrolling)

Full record on ClinicalTrials.gov

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