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RecruitingNCT07623161ELRISE MFUpdated Aug 24, 2026

A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib

A Phase 3 interventional study of Placebo and Elritercept in Myelofibrosis and Anemia, sponsored by Takeda. Recruiting at 195 sites in 31 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Takeda · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
324
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The main aim of this study is to find out how well elritercept works to improve anemia in participants with myelofibrosis (MF) who are taking ruxolitinib when compared to placebo.

Other aims are to learn how elritercept improves anemia compared to placebo; to learn if elritercept reduces tiredness, improves symptoms related to MF, and helps participants do physical activities more easily. The study also aims to find out how elritercept affects the bone marrow, the spleen, and whether participants develop antibodies to the study drug.

The study will also check how safe elritercept is compared to placebo, and if elritercept stays safe over a long period of time. Participants will receive study treatment for at least 9 months (36 weeks). After this period, participants who received placebo will have the option to switch to elritercept.

02

Conditions studied

  • Myelofibrosis
  • Anemia

Keywords

  • TAK-226
  • Drug therapy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged ≥18 years at the time of signing the informed consent form (ICF).
  2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF.
  3. Diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia (post-ET MF) or post-polycythemia vera (post-PV MF) according to the 2022 WHO criteria (WHO Classification of Tumours Editorial Board 2024), confirmed by local pathology report.
  4. Transfusion status as assessed in the 12 weeks immediately preceding randomization classified as Transfusion Dependent: 3 to 8 RBC units over 12 weeks.
  5. Receiving ruxolitinib (as approved in the country of the trial site) as the standard of care treatment for MF for at least 12 consecutive weeks, and on a stable daily dose for at least the 8 weeks immediately preceding the date of randomization.
  6. Eastern Cooperative Oncology Group score less than or equal to (≤) 2.

Exclusion criteria

Exclusion Criteria:

  1. Prior treatment with luspatercept, sotatercept, or other transforming growth factor beta inhibitors or activin receptor ligand traps.

  2. Systemic treatment within 28 days before randomization with any of the following:

    1. Androgens (including danazol). Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed.
    2. erythropoiesis-stimulating agents.
    3. granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor.
    4. High dose corticosteroids. Participants on stable chronic steroid doses of prednisone ≤10 mg/day or corticosteroid equivalent for ≥4 weeks are allowed. Other treatments for autoimmune diseases may be allowed upon medical monitor review.
    5. Hydroxyurea.
    6. Immunomodulatory drugs (for example, thalidomide, pomalidomide, or lenalidomide).
    7. Interferon.
    8. Thrombopoietin receptor agonists.
    9. Any investigational drug, including antihemojuvelin antibody. If the half-life of the investigational product is known, the exclusionary period prior to randomization is equal to 5 half-lives of the investigational product or 28 days, whichever is longer.
  3. Initiation of new iron chelation therapy or dose adjustments to existing iron chelation therapy ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed.
  4. Clinically significant anemia that is due to causes other than MF or Janus kinase (JAK) inhibitor therapy (for example, thalassemia, iron deficiency, vitamin B12 and/or folate deficiencies, autoimmune or hemolytic anemia, infections, or any active clinically significant bleeding or sequestration).
  5. Receipt of RBC transfusion for any reason(s) other than underlying MF within 12 weeks before randomization.
  6. Life expectancy \<12 months per investigator's judgment.

  7. Clinically significant cardiovascular disease, defined as:

    1. New York Heart Association heart disease Class III or IV;
    2. Fridericia corrected QT interval >500 millisecond (ms) during screening;
    3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening.
  8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimetres of mercury (mmHg) and/or diastolic blood pressure ≥100 mmHg despite adequate treatment.
  9. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.

  10. Prior history of malignancies, other than MF. Participants who are free of other malignant disease for ≥2 years and have completed treatment, including maintenance, are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:

    1. Basal or squamous cell carcinoma of the skin;
    2. Carcinoma in situ of the cervix;
    3. Carcinoma in situ of the breast; and/or
    4. Incidental histologic finding of prostate cancer (T1a or T1b using the Tumour, Node, and Metastasis (TNM) staging system);
    5. Early papillary thyroid cancer (stage I [T1-T2, N0, M0]).
  11. History of solid organ or bone marrow transplantation.
  12. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 7 days before randomization. Prophylactic antibiotics and/or antifungals for neutropenia are allowed.
  13. Known positivity for Human Immunodeficiency Virus (HIV), active hepatitis B virus (HBV), or active hepatitis C virus (HCV). Participants without known history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.
  14. Body mass index ≥40 kilograms per square meter (kg/m\^2).
  15. Major surgery within 28 days before randomization.
  16. History of allergy/anaphylaxis to recombinant proteins, investigational product, or excipients (refer to the current elritercept investigator's brochure for a list of excipients), or ruxolitinib.

  17. Any of the following local laboratory abnormalities:

    1. Absolute neutrophil count \<500/microliter (μL) (0.5×109/ liter (L)).
    2. Platelet count \<50,000/μL (50×109/L) or >1,000,000/μL (1000×109/L).
    3. Blasts >5% as assessed in peripheral blood at screening or ≥10% in any historical bone marrow assessments. Participants with isolated transient elevations of peripheral blood blasts may be eligible after discussion between the investigator and medical monitor to confirm the blast count is not indicative of disease progression.
    4. Serum aspartate aminotransferase or alanine aminotransferase ≥3× the upper limit of normal (ULN).
    5. Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin less than (\<) 3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review.
    6. Estimated glomerular filtration rate \<30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration equation.
    7. Ferritin ≤50 micrograms per liter (μg/L).
    8. Folate ≤2.0 nanograms per milliliter (ng/mL).
    9. Vitamin B12 ≤200 picograms per milliliter (pg/mL).
  18. Ongoing participation in another interventional clinical trial.
  19. Participant is unwilling or, in the opinion of the investigator, the participant is unable to comply with the requirements of the protocol.
  20. Is a person of childbearing potential but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of elritercept or placebo.
  21. Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom, during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.
  22. If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.
  23. For participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
324 participants (estimated)

Study arms

  • Experimental
    Elritercept

    Participants will receive elritercept at a starting dose of 3.75 milligrams per kilogram (mg/kg) subcutaneously (SC) once every 4 weeks (Q4W) on Day 1 of each 28-day cycle for approximately 36 weeks during the double-blinded treatment period, with possible up-titration to 5.0 mg/kg from Cycle 3 Day 1 based on response and safety/tolerability. Participants may continue to receive elritercept during the extended open-label treatment period.

    Drug: Elritercept

  • Placebo comparator
    Placebo

    Participants will receive elritercept-matching placebo with equivalent volume to elritercept SC Q4W on Day 1 of each 28-day cycle for approximately 36 weeks during the double-blinded treatment period. Eligible participants may initiate elritercept at a starting dose of 3.75 mg/kg SC Q4W on Day 1 of each 28-day cycle during the extended open-label treatment period, with possible up-titration to 5.0 mg/kg after 2 cycles, based on response and safety/tolerability.

    Drug: Placebo · Drug: Elritercept

Interventions

  • DrugPlacebo

    Elritercept-matching placebo

  • DrugElritercept

    Elritercept, SC, injection

    Also known as: TAK-226

05

What researchers measure

Primary outcomes

  1. Proportion of Participants Who Are Red Blood Cell-Transfusion Independent (RBC-TI) for Any Consecutive Greater Than or Equal to (≥) 12-Week Period During the 36-Week Double-Blinded Treatment Period

    RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

Secondary outcomes

  1. Proportion of Participants Who Achieve ≥50 Percent (%) Reduction in RBC Transfusion Burden From Baseline Over Any Consecutive 12-Week Period

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  2. Proportion of Participants Who Are RBC-TI for Any Consecutive ≥16-Week Period

    RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  3. Proportion of Participants Who Are RBC-TI for Any Consecutive ≥12-Week Period With Concurrent Mean Hemoglobin (Hgb) Increase ≥1.5 Grams per Deciliter (g/dL) From Baseline

    RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  4. Proportion of Participants Who Are RBC-TI for Any Consecutive ≥24-Week Period

    RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  5. Proportion of Participants Who Are RBC-TI for Any Consecutive ≥12-Week Period With Concurrent Mean Hgb Increase of ≥1.0 g/dL and ≥2.0 g/dL From Baseline

    RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  6. Proportion of Participants Who Are RBC-TI for Any Consecutive 16- or 24-Week Period With a Concurrent Mean Hgb Increase of ≥1.0 g/dL, ≥1.5 g/dL, and ≥2.0 g/dL From Baseline

    RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  7. Maximum Duration of RBC-TI for Participants Who Achieved RBC-TI for a Consecutive ≥12 Weeks

    RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  8. Maximum Duration of RBC-TI With Concurrent Mean Hgb Increase of ≥1.5 g/dL for Participants Who Achieved Consecutive ≥12 Weeks RBC-TI With Concurrent Mean Hgb Increase of ≥1.5 g/dL

    RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  9. Time to Onset of Anemia Response

    Time to onset of anemia response is defined as the duration between the date of randomization and the date participant first achieved anemia response status. Anemia response is evaluated as: achievement of RBC-TI for any consecutive ≥12-week, ≥16-week, or ≥24-week period or ≥50% reduction in red blood cell transfusion burden from baseline over any consecutive 12 weeks.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  10. Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Fatigue 7a T-Score at Week 36

    PROMIS Short Form v1.0 - Fatigue 7a is a 7-item, patient-reported measure designed to assess fatigue symptoms and impact over the past 7 days. Response options are on a 5-point scale from never (1) to always (5). Raw scores are computed by summing responses to all 7 items and then converted to a standardized T-score on a scale from 0 to 100 with a mean of 50 and SD of 10 with higher scores representing worse fatigue. T-scores can be produced using a conversion table available from the instrument developer or using response pattern scoring performed by the Health Measures Scoring Service.

    Time frame: Baseline, Week 36

  11. Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue Scale Score at Week 36

    EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participants with cancer. The questionnaire's items are divided among 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social), 3 multi-item scales measuring symptoms (fatigue, nausea/vomiting, and pain), 6 items measuring symptoms (dyspnea, insomnia, appetite loss, constipation, and diarrhea) as well as financial difficulties, and a 2-item scale measuring global health status (GHS))/quality of life (QoL). Items included in GHS/QoL scale use a 7-point response metric ranging from very poor to excellent, while other items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning, GHS/QoL, or worse symptomatology.

    Time frame: Baseline, Week 36

  12. Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in PROMIS Short Form v1.0 - Fatigue 7a T-score

    PROMIS Short Form v1.0 - Fatigue 7a is a 7-item, patient-reported measure designed to assess fatigue symptoms and impact over the past 7 days. Response options are on a 5-point scale from never (1) to always (5). Raw scores are computed by summing responses to all 7 items and then converted to a standardized T-score on a scale from 0 to 100 with a mean of 50 and SD of 10 with higher scores representing worse fatigue. T-scores can be produced using a conversion table available from the instrument developer or using response pattern scoring performed by the Health Measures Scoring Service. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  13. Time to Meaningful Improvement and Meaningful Deterioration in PROMIS Short Form v1.0 - Fatigue 7a T-Score From Baseline

    PROMIS Short Form v1.0 - Fatigue 7a is a 7-item, patient-reported measure designed to assess fatigue symptoms and impact over the past 7 days. Response options are on a 5-point scale from never (1) to always (5). Raw scores are computed by summing responses to all 7 items and then converted to a standardized T-score on a scale from 0 to 100 with a mean of 50 and SD of 10 with higher scores representing worse fatigue. T-scores can be produced using a conversion table available from the instrument developer or using response pattern scoring performed by the Health Measures Scoring Service. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  14. Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Fatigue Scale Score

    EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The items are divided among 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social), 3 multi-item scales measuring symptoms (fatigue, nausea/vomiting, pain), 6 items measuring symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) as well as financial difficulties, and a 2-item scale measuring GHS and QoL. Items included in GHS/QoL scale use a 7-point response metric ranging from very poor to excellent, while other items use a 4-point response metric, categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning, better GHS/QoL, or worse symptomatology. Score cutoffs to define meaningful improvement/deterioration to be determined before primary analysis.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  15. Time to Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Fatigue Scale Score From Baseline

    EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The items are divided among 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, social), 3 multi-item scales measuring symptoms (fatigue, nausea/vomiting, pain), 6 items measuring symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) as well as financial difficulties, and a 2-item scale measuring GHS and QoL. Items included in GHS/QoL scale use a 7-point response metric ranging from very poor to excellent, while other items use a 4-point response metric, categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning, better GHS/QoL, or worse symptomatology. Score cutoffs to define meaningful improvement/deterioration to be determined before primary analysis.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  16. Mean Changes From Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 7-Item Total Symptom Score at Week 36

    MFSAF v4.0 is a unidimensional measure assessing 7 core MF symptoms: fatigue, night sweats, itching, abdominal discomfort, pain under ribs, early satiety, and bone pain. The questionnaire asks participants to rate each symptom at its worst during the past 7 days on a 0 to 10 numeric rating scale ranging from absent (0) to worst imaginable (10). The Total Symptom Score (TSS) is calculated as the average of the 7 individual item responses multiplied by 7, yielding a score range of 0 to 70 with higher scores representing worse symptom severity.

    Time frame: Baseline, Week 36

  17. Proportion of Participants Achieving Confirmed 50% Reduction in MFSAF v4.0 Total Symptom Score (TSS50)

    MFSAF v4.0 is a unidimensional measure assessing 7 core MF symptoms: fatigue, night sweats, itching, abdominal discomfort, pain under ribs, early satiety, and bone pain. The questionnaire asks participants to rate each symptom at its worst during the past 7 days on a 0 to 10 numeric rating scale ranging from absent (0) to worst imaginable (10). The TSS is calculated as the average of the 7 individual item responses multiplied by 7, yielding a score range of 0 to 70 with higher scores representing worse symptom severity.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  18. Time to Symptom Response in MFSAF TSS50 From Baseline

    MFSAF v4.0 is a unidimensional measure assessing 7 core MF symptoms: fatigue, night sweats, itching, abdominal discomfort, pain under ribs, early satiety, and bone pain. The questionnaire asks participants to rate each symptom at its worst during the past 7 days on a 0 to 10 numeric rating scale ranging from absent (0) to worst imaginable (10). The TSS is calculated as the average of the 7 individual item responses multiplied by 7, yielding a score range of 0 to 70 with higher scores representing worse symptom severity.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  19. Mean Change From Baseline EORTC QLQ-C30 Physical Functioning Scale Score at Week 36

    EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The questionnaire's items include 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social). These items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning.

    Time frame: Baseline, Week 36

  20. Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Physical Functioning Scale Score

    EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The questionnaire's items include 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social). These items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  21. Time to Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Physical Functioning Scale Score From Baseline

    EORTC QLQ-C30 is a 30-item, participant-reported multidomain questionnaire designed to assess functioning, wellbeing, and symptom experience of participant with cancer. The questionnaire's items include 5 multi-item scales measuring functioning (physical, role, emotional, cognitive, and social). These items use a 4-point response metric with categories including not at all, a little, quite a bit, and very much. Scale scores are transformed to range from 0 to 100 with higher scores indicating better functioning. Score cutoffs to define meaningful improvement and meaningful deterioration will be determined prior to the primary analysis based on analysis of blinded trial data in accordance with a prespecified psychometric analysis plan.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  22. Proportion of Participants With Platelet Response During the 36-Week Double-Blinded Treatment Period

    Platelet response includes a mean increase of ≥30×10\^9/ liter (L) from baseline, a \>50% increase from baseline with a count ≥50×10\^9/L, and conversion from \<100 to ≥100×10\^9/L, each sustained for ≥12 weeks.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  23. Proportion of Participants Achieving Spleen Volume Reduction (SVR) From Baseline as Measured by Computed Tomography/Magnetic Resonance Imaging (CT/MRI) During the 36-Week Double-Blinded Treatment Period

    Proportion of participants achieving SVR of ≥10%, ≥25%, or ≥35% will be presented for this outcome measure.

    Time frame: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

  24. Proportion of Participants Who Develop Accelerated Phase (AP) MF

    Time frame: Up to approximately 7 years

  25. Time to Progression in Participants Who Develop AP MF

    Time frame: Up to approximately 7 years

  26. Proportion of Participants Who Develop Blast Phase (BP) MF

    Time frame: Up to approximately 7 years

  27. Time to Progression in Participants Who Develop BP MF

    Time frame: Up to approximately 7 years

  28. Plasma Concentration-Time Data for Participants Treated With Elritercept

    Time frame: At multiple time points from Cycle 1 Day 1 (each cycle is 28 days) up to approximately 7 years

  29. Proportion of Participants Treated With Elritercept who Have Antidrug Antibodies

    Time frame: At multiple time points from Cycle 1 Day 1 (each cycle is 28 days) up to approximately 7 years

  30. Overall Survival (OS)

    OS is defined as the time from randomization to the date of death due to any cause.

    Time frame: From randomization to 7 years

06

Study locations

2 of 195 sites recruiting
  • Banner MD Anderson Cancer Center
    Gilbert, Arizona 85234, United States
    Not yet recruiting
  • Los Angeles Cancer Network
    Glendale, California 91204, United States
    Not yet recruiting
  • Cancer and Blood Specialty Clinic
    Whittier, California 90603, United States
    • Site Contact · Contact · mshum@cbsclinic.com · 562-698-6888
    • Merrill Shum · Principal investigator
    Not yet recruiting
  • MedStar Georgetown University Hospital
    Washington D.C., District of Columbia 20007, United States
    Not yet recruiting
  • Advanced Research, LLC
    Coral Springs, Florida 33065, United States
    Recruiting
  • Bioresearch Partners
    Miami, Florida 33143, United States
    Not yet recruiting
  • AdventHealth - Cancer Institute - Orlando
    Orlando, Florida 32804-4648, United States
    Not yet recruiting
  • Florida Clinical Trials Group
    Tamarac, Florida 33321, United States
    Not yet recruiting
  • Moffit Cancer Center
    Tampa, Florida 33612, United States
    Not yet recruiting
  • Emory University
    Atlanta, Georgia 30322, United States
    Not yet recruiting
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
    Not yet recruiting
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
    • Site Contact · Contact · a.zhou@wustl.edu · 314-362-8814
    • Amy Zhou · Principal investigator
    Not yet recruiting
  • St. Vincent Regional Hospital Cancer Centers
    Billings, Montana 59101, United States
    Not yet recruiting
  • University of New Mexico Comprehensive Cancer Center
    Albuquerque, New Mexico 87102, United States
    Not yet recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10021, United States
    • Site Contact · Contact · chernakb@mskcc.org · 646-608-4366
    • Brian Chernak · Principal investigator
    Not yet recruiting
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
    Not yet recruiting
  • Duke Blood Cancer Center
    Durham, North Carolina 27705, United States
    Not yet recruiting
  • Novant Health
    Winston-Salem, North Carolina 27103, United States
    Not yet recruiting
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
    • Site Contact · Contact · gerdsa@ccf.org · 772-297-3057
    • Aaron Gerds · Principal investigator
    Not yet recruiting
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
    • Site Contact · Contact · stempelj@ohsu.edu · 503-494-8311
    • Jessica Stempel · Principal investigator
    Not yet recruiting
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
    Not yet recruiting
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15219, United States
    • Site Contact · Contact · jrossett@wpahs.org · 412-623-6037
    • James Rossetti · Principal investigator
    Not yet recruiting
  • Allegheny Health Network Cancer Institute - West Penn Hospital Location
    Pittsburgh, Pennsylvania 15224, United States
    • Site Contact · Contact · anna.koget@ahn.org · 412-578-4484
    • Anna Koget · Principal investigator
    Not yet recruiting
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
    • Site Contact · Contact · baratamp@musc.edu · 843-792-4271
    • Praneeth Baratam · Principal investigator
    Not yet recruiting
  • Vanderbilt-Ingram Cancer Center (VICC)-Nashville
    Nashville, Tennessee 37232-0021, United States
    Not yet recruiting
  • Baylor University Medical Center
    Dallas, Texas 75246, United States
    Not yet recruiting
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
    • Site Contact · Contact · pbose@mdanderson.org · 713-792-7747
    • Prithviraj Bose · Principal investigator
    Not yet recruiting
  • The University of Utah-Huntsman Cancer Institute
    Houston, Texas 77030, United States
    Not yet recruiting
  • LUMI Research
    Houston, Texas 77090, United States
    Recruiting
  • University of Washington
    Seattle, Washington 98109, United States
    • Site Contact · Contact · halpern2@uw.edu · 206-606-1978
    • Anna Halpern · Principal investigator
    Not yet recruiting
  • Hospital Universitario Austral
    Pilar, Buenos Aires B1629AHJ, Argentina
    Not yet recruiting
  • Swiss Medical Center Barrio Parque
    Buenos Aires, Ciudad Autonoma de BuenosAires 1405, Argentina
    • Site Contact · Contact · miastrebner@gmail.com · 5491169816300
    • Claudio Marcelo Iastrebner · Principal investigator
    Not yet recruiting
  • Instituto Medico de la Fundacion Estudios Clinicos
    Rosario, Santa Fe Province 2000, Argentina
    Not yet recruiting
  • Hospital Privado de Rosario
    Rosario, Santa Fe Province S2000GAP, Argentina
    Not yet recruiting
  • Hospital Aleman (HA) Deutsches Hospital
    Buenos Aires, CPC1118AAT, Argentina
    Not yet recruiting
  • BRCR Global
    Córdoba, 5000, Argentina
    Not yet recruiting
  • Flinders Medical Centre
    Bedford Park, Adelaide, SA 5042, Australia
    Not yet recruiting
  • Mid North Coast Cancer Institute (MNCCI)
    Coffs Harbour, New South Wales 2450, Australia
    Not yet recruiting
  • Tweed Valley Hospital
    Cudgen, New South Wales 2487, Australia
    Not yet recruiting
  • South Eastern Sydney Local Health District
    Kogarah, New South Wales 2217, Australia
    Not yet recruiting
  • Medizinische Universitat Wien (Medical University of Vienna - Austria)
    Vienna, A 1090, Austria
    Not yet recruiting
  • Medizinische Universitat Innsbruck
    Innsbruck, Tyrol 6020, Austria
    Not yet recruiting
  • Klinikum Wels-Grieskirchen
    Wels, Upper Austria 4600, Austria
    Not yet recruiting
  • Ordensklinikum Linz Elisabethinen
    Linz, 4020, Austria
    Not yet recruiting
  • Centre Hospitalier Jolimont-Lobbes
    La Louvière, Hainaut 7100, Belgium
    Not yet recruiting
  • UZ Leuven
    Leuven, Vlaams-Brabant 3000, Belgium
    Not yet recruiting
  • AZ Delta
    Roeselare, West-Vlaanderen 8800, Belgium
    Not yet recruiting
  • Ziekenhuis aan de Stroom-Cadix
    Antwerp, 2030, Belgium
    Not yet recruiting
  • CHU Namur Site Mont Godinne
    Yvoir, 5530, Belgium
    Not yet recruiting
  • Centro de Ensino, Pesquisa e Inovacao do Hospital Sao Lucas (CEPIN HSL RJ / Rede Americas)
    Rio de Janeiro, Rio de Janeiro 22061080, Brazil
    • Site Contact · Contact · csolza@hotmail.com · 5521991854223
    • Cristiane Solza · Principal investigator
    Not yet recruiting
  • Porto Alegre Clinical Hospital (HCPA)
    Porto Alegre, Rio Grande do Sul 90035-903, Brazil
    Not yet recruiting
  • Hospital Mae De Deus - Integrated Oncology Center
    Porto Alegre, Rio Grande do Sul 90110-270, Brazil
    Not yet recruiting
  • Hospital Sao Lucas da PUCRS
    Porto Alegre, Rio Grande do Sul 90610-000, Brazil
    • Site Contact · Contact · mzschaan@hotmail.com · 555133203005
    • Mariza Schaan · Principal investigator
    Not yet recruiting
  • Grupo Elora Pesquisa Clinica
    Florianópolis, Santa Catarina 88020-210, Brazil
    Not yet recruiting
  • Centro de Hematologia e Oncologia (CHO)
    Joinville, Santa Catarina 89201-260, Brazil
    Not yet recruiting
  • Hospital Amaral Carvalho (HAC)
    Jaú, São Paulo 17210-080, Brazil
    Not yet recruiting
  • Portuguese Charity of Sao Paulo
    São Paulo, 01323-900, Brazil
    • Site Contact · Contact · scheinbp@gmail.com · 113505-5022
    • Phillip Scheinberg · Principal investigator
    Not yet recruiting
  • UMHAT 'Dr. Georgi Stranski', EAD
    Pleven, 5800, Bulgaria
    • Site Contact · Contact · slavcheva_v@yahoo.com · 359887450850
    • Vanya Slavcheva-Popova · Principal investigator
    Not yet recruiting
  • Dr. Pencho Georgiev - Outpatient Center
    Plovdiv, 4002, Bulgaria
    Not yet recruiting
  • UMHAT Sv. Ivan Rilski
    Sofia, 1431, Bulgaria
    • Site Contact · Contact · aradinoff@hotmail.com · 359884933151
    • Atanas Radinoff · Principal investigator
    Not yet recruiting
  • Specialized Hospital for Active Treatment of Haematological Diseases - Sofia
    Sofia, 1797, Bulgaria
    Not yet recruiting
  • Juravinski Cancer Centre
    Hamilton, Ontario L8V 5C2, Canada
    • Site Contact · Contact · hillis@hhsc.ca · 905 387 9495
    • Hillis Christopher · Principal investigator
    Not yet recruiting
  • Princess Margaret Cancer Centre
    Toronto, Ontario M5G 2M9, Canada
    • Site Contact · Contact · dawn.maze@uhn.ca · 4169464501
    • Dawn Maze · Principal investigator
    Not yet recruiting
  • Jewish General Hospital
    Montreal, Quebec H3T1E2, Canada
    Not yet recruiting
  • McGill University Health Center
    Montreal, Quebec H4A 3J1, Canada
    Not yet recruiting
  • Hospital Cliniico Regional de Concepcion Dr
    Concepción, Biobio 4030000, Chile
    Not yet recruiting
  • IC La Serena Research
    La Serena, Coquimbo Region 01697, Chile
    Not yet recruiting
  • Icegclinic
    Santiago, La Florida 8241479, Chile
    Not yet recruiting
  • Immunocel
    Las Condes, Santiago Metropolitan 7560908, Chile
    Not yet recruiting
  • Centro de Oncologia de Precision
    Santiago, Santiago Metropolitan 7850000, Chile
    Not yet recruiting
  • Hospital Pablo Tobon Uribe
    Medellín, Antioquia 0000000, Colombia
    Not yet recruiting
  • Clinica General del Norte De Barranquilla
    Barranquilla, Atlántico 080002, Colombia
    Not yet recruiting
  • Los Cobos Medical Center
    Bogotá, Bogota D.C. 110121, Colombia
    Not yet recruiting
  • Funcacion santa Fe De Bogota
    Bogota, Cundinamarca 11011, Colombia
    Not yet recruiting
  • Masaryk University Hospital Brno, Department of Internal Medicine, Hematology and Oncology
    Brno, Czech Republic 625 00, Czechia
    Not yet recruiting
  • Fakultni nemocnice Hradec Kralove
    Hradec Králové, CZ 50005, Czechia
    Not yet recruiting
  • Vseobecna fakultni nemocnice Praha
    Prague, CZ 12808, Czechia
    Not yet recruiting
  • Fakultni nemocnice Kralovske Vinohrady
    Prague, 134 00, Czechia
    • Site Contact · Contact · Olga.cerna@fnkv.cz · 267162887
    • Olga Cerna · Principal investigator
    Not yet recruiting
  • CHU de Nice
    Nice, Alpes Maritimes 6002, France
    • Site Contact · Contact · loschi.m@chu-nice.fr · 492035558
    • Michael Loschi · Principal investigator
    Not yet recruiting
  • Centre Hospitalier Lyon Sud
    Pierre-Bénite, Auvergne-Rhône-Alpes 69495, France
    Not yet recruiting
  • CHU de Strasbourg
    Strasbourg, Bas Rhin 67200, France
    Not yet recruiting
  • Institut Paoli Calmettes
    Marseille, Bouches-du-Rhone 13009, France
    Not yet recruiting
  • Centre Hospitalier Regional Universitaire Brest Hopital Morvan
    Brest, Finistere 29609, France
    Not yet recruiting
  • CHU de Bordeaux
    Pessac, Gironde 33600, France
    Not yet recruiting
  • Centre Hospitalier Regional Universitaire de Lille
    Lille, Nord 59037, France
    Not yet recruiting
  • Assistance Publique Hopitaux de Paris
    Paris, Paris 75015, France
    Not yet recruiting
  • CHU de Poitiers
    Poitiers, Vienne 86021, France
    Not yet recruiting
  • Universitaetsklinikum Freiburg
    Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany
    Not yet recruiting
  • Universitaetsklinikum Heidelberg (UKHD)
    Heidelberg, Baden-Wurttemberg 69120, Germany
    Not yet recruiting
  • Kliniken Ostalb
    Mutlangen, Baden-Wurttemberg 73557, Germany
    Not yet recruiting
  • Muehlenkreiskliniken AoeR-Johannes Wesling Klinikum Minden - Universitaetsklinik fuer Neurologie und Neurogeriatrie
    Minden, North Rhine-Westphalia 32429, Germany
    Not yet recruiting
  • Institut fur Versorgungsforschung in der Onkologie GbR
    Koblenz, Rhineland-Palatinate 56068, Germany
    • Site Contact · Contact · lutz@invo-koblenz.de · 261921569323
    • Cristoph Lutz · Principal investigator
    Not yet recruiting
  • Klinikum Chemnitz GmbH
    Chemnitz, Saxony 9116, Germany
    • Site Contact · Contact · m.haenel@skc.de · 37133344500
    • Mathias Hanel · Principal investigator
    Not yet recruiting
  • University Hospital Halle (Saale)
    Halle, Saxony-Anhalt 06120, Germany
    Not yet recruiting
  • Universitaetsklinikum Jena
    Jena, Thuringia 7743, Germany
    Not yet recruiting
  • Praxis am Volkspark
    Berlin, 10715, Germany
    Not yet recruiting
  • Olympion General Clinic & Rehabilitation Center
    Pátrai, Ahaia 264 43, Greece
    Not yet recruiting
  • Laiko General Hospital of Athens
    Athens, Attica 11526, Greece
    • Site Contact · Contact · theopvass@hotmail.com · 302132060962
    • Theodoros Vassilakopoulos · Principal investigator
    Not yet recruiting
  • General Hospital
    Athens, Attica 11527, Greece
    Not yet recruiting
  • Alexandra General Hospital of Athens
    Athens, Attica 11528, Greece
    • Site Contact · Contact · mdimop@med.uoa.gr · 30 213 216 2540-41
    • Meletios-Athanasios Dimopoulos · Principal investigator
    Not yet recruiting

Showing the first 100 of 195 sites across 31 countries.

07

References and documents

Individual participant data

Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting information: Study protocol, Sap, Icf, Csr

08

Registry details

Key details

Study ID
NCT07623161
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Jun 3, 2026
Start date
Sep 2, 2026 (estimated)
Primary completion
Dec 7, 2029 (estimated)
Completion
Mar 30, 2034 (estimated)
Last update
Aug 24, 2026

Study contacts

Takeda Contact
Contact
medinfoUS@takeda.com
+1-877-825-3327
Study Director
study director · Takeda

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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