A Study of Elritercept Alone or Together With Ruxolitinib in Adults With Myelofibrosis
NCT ID: NCT05037760
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
135 participants
INTERVENTIONAL
2021-12-16
2030-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm 1A: Elritercept
Participants with anemia who have discontinued Janus Kinase (JAK) inhibitor(s) or are intolerant or ineligible for JAK inhibitor(s) will be administered escalating doses of elritercept, starting at 0.75 milligrams per kilograms (mg/kg) followed by 1.5 mg/kg and 4.5 mg/kg subcutaneously (SC), every 4 weeks for 13 cycles for a total Treatment Period of 52 weeks. Each cycle is 28 days.
Elritercept
Elritercept SC injection.
Arm 1B: Elritercept + Ruxolitinib
Participants with anemia who have been receiving ruxolitinib for ≥8 weeks prior to Cycle 1 Day 1 (C1D1) and are on a stable dose for ≥4 weeks prior to C1D1 will be administered escalating doses of elritercept, starting at 0.75 mg/kg and followed by 1.5 mg/kg and 4.5 mg/kg, SC, every 4 weeks for 13 cycles in combination with ruxolitinib therapy for a total Treatment Period of 52 weeks. Each cycle is 28 days.
Elritercept
Elritercept SC injection.
Ruxolitinib
Ruxolitinib tablet.
Arm 2A: Elritercept
Participants with with anemia who have discontinued JAK inhibitor(s) or are intolerant or ineligible for JAK inhibitor(s) will be administered elritercept, 3.75 mg/kg, SC, every 4 weeks for 13 cycles for a total Treatment Period of 52 weeks. Each cycle is 28 days.
Elritercept
Elritercept SC injection.
Arm 2B: Elritercept + Ruxolitinib
Participants with anemia who have been receiving ruxolitinib for ≥8 weeks prior to C1D1 and are on a stable dose for ≥4 weeks prior to C1D1 will be administered elritercept, 3.75 mg/kg, SC, every 4 weeks for 13 cycles in combination with ruxolitinib therapy for a total Treatment Period of 52 weeks. Each cycle is 28 days.
Elritercept
Elritercept SC injection.
Ruxolitinib
Ruxolitinib tablet.
Experimental: Arm 2C: Elritercept (Brazil Only)
Participants from Brazil with anemia who have received no prior treatment with JAK inhibitor(s) and have no access to JAK inhibitor therapy will be administered elritercept, 3.75 mg/kg, SC, every 4 weeks for 13 cycles for a total Treatment Period of 52 weeks. Each cycle is 28 days.
Elritercept
Elritercept SC injection.
Long-Term Extension
Participants from Arms 1A, 1B, 2A, 2B and 2C benefiting from the continued elritercept treatment as a monotherapy or in combination with ruxolitinib can continue to receive elritercept in this long-term extension phase until elritercept becomes commercially available or until elritercept is no longer being developed for the treatment of MF.
Elritercept
Elritercept SC injection.
Ruxolitinib
Ruxolitinib tablet.
Interventions
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Elritercept
Elritercept SC injection.
Ruxolitinib
Ruxolitinib tablet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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).
3. Male or female greater than equal to (≥)18 years of age, at the time of signing informed consent.
4. Eastern Cooperative Oncology Group (ECOG) performance score lesser than equal to (≤)2.
5. Life expectancy ≥12 months per Investigator assessment.
6. 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.
7. Anemia, defined as:
1. 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
2. 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.
8. Arm-specific criteria:
Arms 1A and 2A:
1. 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
2. Participants previously treated with JAK inhibitor(s) must have discontinued JAK inhibitor therapy ≥8 weeks before C1D1
Arms 1B and 2B:
1. 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.
2. 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
* The participant's disease is symptomatic and warrants additional therapy
Arm 2C (Brazil only):
1. No prior treatment with JAK inhibitor(s) and no access to JAK inhibitor therapy as determined by the Investigator
2. Spleen volume ≥ 450 cubic centimeter (cm\^3) as assessed by CT or MRI collected during the pretreatment period and/or
3. Myelofibrosis Symptom Assessment Form Total Symptom Score (MF-SAF-TSS) meeting at least one of the following criteria during the pretreatment period:
* 2 symptoms with average score ≥ 3
* Average total symptom score ≥ 10
9. Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception as described in the protocol.
Exclusion Criteria
1. 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.
2. Presence of the following cardiac conditions:
1. New York Heart Association Class 3 or 4 heart failure
2. QTcF (QT interval corrected by Fridericia's formula) \>500 milliseconds (msec) on the screening or C1D1 electrocardiogram (ECG; mean of 3 measurements)
3. Uncontrolled clinically significant arrhythmia (participants with rate-controlled atrial fibrillation are not excluded)
4. Acute myocardial infarction or unstable angina pectoris ≤6 months prior to C1D1
3. Body mass index (BMI) ≥40 kilograms per meter square (kg/m\^2).
4. Presence of uncontrolled hypertension, defined as systolic blood pressure ≥160 millimeters of mercury (mmHg) or diastolic blood pressure ≥100 mmHg despite adequate treatment.
5. History of drug or alcohol abuse (as defined by the Investigator) within the past 2 years.
6. History of stroke, deep venous thrombosis, or arterial embolism within 6 months prior to C1D1.
7. 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.
8. 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.
9. 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.
10. History of solid organ or hematological transplantation.
11. 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.
12. Diagnosis of hemolytic anemia, active bleeding, hemoglobinopathies, or congenital disorders as a cause of the participant's anemia.
13. History of intracranial hemorrhage (any grade).
14. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 bleeding events within the 3 months prior to C1D1.
15. 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:
16. Prior treatment with luspatercept, sotatercept, or other commercially available or investigational transforming growth factor-beta (TGF-β) inhibitors (all arms).
17. Treatment within 28 days prior to C1D1 with:
1. Erythropoiesis-stimulating agent (ESA)
2. Granulocyte colony-stimulating factor (G-CSF)
3. Granulocyte-macrophage colony-stimulating factor (GM-CSF)
4. Thrombopoietin (TPO) agonists
5. Immunomodulator imide drugs (IMiDs) (e.g., thalidomide, pomalidomide, lenalidomide)
6. Interferon
7. Hydroxyurea
8. Steroids at doses exceeding corticosteroid equivalent of 10 mg/day prednisone
18. Newly initiated iron chelation therapy within the 8 weeks prior to C1D1. Stable doses of iron chelators are allowed if prescribed per label.
19. Vitamin B12 and/or folate therapy initiated within 4 weeks before randomization. Participants on stable replacement doses for ≥4 weeks and without concurrent vitamin B12 or folate deficiency are allowed.
20. Treatment with another investigational drug or device or approved therapy for the treatment of MF or anemia in MF ≤28 days prior to C1D1, or, if the half-life of the previous product is known, within 5 times the half-life prior to C1D1, whichever is longer.
21. For Arms 1B and 2B (participants receiving ruxolitinib), initiation of treatment with strong cytochrome P450 (CYP)3A4 inhibitors within 2 weeks prior to C1D1. Participants receiving CYP3A4 inhibitors/inducers as concomitant therapy with ruxolitinib in accordance with ruxolitinib local prescribing information may continue to receive such therapies in this study.
Laboratory Exclusions (during screening):
22. Bone marrow aspirate blast percentage \>5 percent (%)
a. In the event of a non-evaluable pretreatment bone marrow aspirate expected to be due to marrow fibrosis, participants may be enrolled without bone marrow aspirate blast percentage data if all other eligibility criteria are met. Historical bone marrow data may be requested to support confirmation of diagnosis.
23. Peripheral blood blast percentage ≥10%
24. Platelet count \<25 × 10\^9 per liter (10\^9/)L or \>450 × 10\^9/L
25. Persistent Hgb \<7 g/dL despite RBC transfusions
26. Transferrin saturation \<15%
27. Ferritin \<50 nanograms per mililiters (ng/mL)
28. Folate \<4.5 nanomoles per liter (nmol/L) (\<2.0 picograms per liter (pg/L))
29. Vitamin B12 \<148 picomoles per liter (pmol/L) (\<200 picograms per milliliter (pg/mL))
30. Estimated glomerular filtration rate \<30 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) (as determined by the Chronic Kidney Disease Epidemiology Collaboration equation)
31. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \>3 × upper limit of normal (ULN)
32. Total bilirubin \>2 × ULN
33. International normalized ratio (INR) \>1.2 × ULN, unless participant is receiving anticoagulation, in which instance the INR must fall within the participant's designated therapeutic range.
Miscellaneous:
34. Pregnant or lactating females.
35. Any other condition not specifically noted above that, in the opinion of the Investigator or Sponsor, would preclude the participant from participating in the study.
36. Participants who are investigational site staff members directly involved in the conduct of the study and their immediate family members, site staff members otherwise supervised by the Investigator, or participants who are Keros or contract research organization (CRO) employees directly involved in the conduct of the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Concord Hospital
Concord, New South Wales, Australia
The Tweed Hospital
Tweed Heads, New South Wales, Australia
Flinders Medical Centre
Woodville South, South Australia, Australia
St. Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Ballarat Oncology & Haematology Service
Wendouree, Victoria, Australia
Hospital de Clinicas de Porto Alegre
Porto Alegre, , Brazil
IMV-Pesquisa Cardiologica Sociedade Simples
Porto Alegre, , Brazil
Albert Einstein Sociedade Beneficente Israelita Brasiliera
São Paulo, , Brazil
Hospital Beneficencia Portuguesa de Sao Paulo
São Paulo, , Brazil
Hospital Das Clinicas Da Faculdade de Medicina Da U S P
São Paulo, , Brazil
Instituto de Ensino e Pesquisas Sao Lucas
São Paulo, , Brazil
CHU Amiens - Hopital Sud
Amiens, , France
Hopital Morvan
Brest, , France
Hopital Prive Sevigne
Cesson-Sévigné, , France
Centre Hospitalier Lyon Sud
Lyon, , France
Institut de Cancerologie du Gard
Nîmes, , France
Hopital de la Source - CHR Orleans
Orléans, , France
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, , Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, , Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, , Italy
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Ospedale Policlinico San Martino
Genova, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Niguarda Cancer Center
Milan, , Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Milan, , Italy
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
Reggio Emilia, , Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I
Roma, , Italy
Azienda Socio Sanitaria Territoriale Sette Laghi
Varese, , Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, , Italy
Gachon University Gil Medical Center
Incheon, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul St. Marys Hospital, The Catholic University of Korea
Seoul, , South Korea
Soonchunhyang University Seoul Hospital
Seoul, , South Korea
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital QuironSalud de Zaragoza
Zaragoza, , Spain
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-507468-38-00
Identifier Type: CTIS
Identifier Source: secondary_id
KER050-MF-301
Identifier Type: -
Identifier Source: org_study_id
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