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New hope for myelofibrosis patients: experimental drug KER-050 enters phase 2 trial

NCT ID NCT05037760

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called elritercept (KER-050) for people with myelofibrosis, a rare bone marrow disorder. The drug is given alone or with the standard treatment ruxolitinib. The main goals are to check safety and see if it helps with anemia and other symptoms. About 135 adults will take part in this phase 2 trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 135 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 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: Medical History: 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.

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Conditions

The condition(s) this trial relates to.

anemia myelofibrosis primary myelofibrosis thrombocytopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelofibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    39 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ASST Grande Ospedale Metropolitano Niguarda, Niguarda Cancer Center

    RECRUITING

    Milan, Italy

  • Albert Einstein Sociedade Beneficente Israelita Brasiliera

    RECRUITING

    São Paulo, Brazil

  • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

    RECRUITING

    Reggio Emilia, Italy

  • Azienda Ospedaliera Universitaria Careggi

    RECRUITING

    Florence, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona

    RECRUITING

    Verona, Italy

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    RECRUITING

    Bologna, Italy

  • Azienda Ospedaliera Universitaria Policlinico Umberto I

    RECRUITING

    Roma, Italy

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

    RECRUITING

    Bari, Italy

  • Azienda Socio Sanitaria Territoriale Sette Laghi

    RECRUITING

    Varese, Italy

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    RECRUITING

    Brescia, Italy

  • Ballarat Oncology & Haematology Service

    RECRUITING

    Wendouree, Victoria, 3355, Australia

  • CHU Amiens - Hopital Sud

    COMPLETED

    Amiens, France

  • Centre Hospitalier Lyon Sud

    RECRUITING

    Lyon, France

  • Concord Hospital

    RECRUITING

    Concord, New South Wales, Australia

  • Flinders Medical Centre

    RECRUITING

    Woodville South, South Australia, 5042, Australia

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    COMPLETED

    Milan, Italy

  • Gachon University Gil Medical Center

    COMPLETED

    Incheon, South Korea

  • Guys Hospital

    RECRUITING

    London, United Kingdom

  • Hammersmith Hospital

    RECRUITING

    London, United Kingdom

  • Hopital Morvan

    COMPLETED

    Brest, France

  • Hopital Prive Sevigne

    COMPLETED

    Cesson-Sévigné, France

  • Hopital de la Source - CHR Orleans

    COMPLETED

    Orléans, France

  • Hospital Beneficencia Portuguesa de Sao Paulo

    RECRUITING

    São Paulo, Brazil

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, Spain

  • Hospital Das Clinicas Da Faculdade de Medicina Da U S P

    RECRUITING

    São Paulo, Brazil

  • Hospital QuironSalud de Zaragoza

    RECRUITING

    Zaragoza, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, Spain

  • Hospital Universitario La Princesa

    RECRUITING

    Madrid, Spain

  • Hospital Universitario de Salamanca

    RECRUITING

    Salamanca, Spain

  • Hospital de Clinicas de Porto Alegre

    RECRUITING

    Porto Alegre, Brazil

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol

    RECRUITING

    Badalona, Spain

  • IMV-Pesquisa Cardiologica Sociedade Simples

    RECRUITING

    Porto Alegre, Brazil

  • Institut de Cancerologie du Gard

    RECRUITING

    Nîmes, France

  • Instituto de Ensino e Pesquisas Sao Lucas

    RECRUITING

    São Paulo, Brazil

  • Ospedale Policlinico San Martino

    RECRUITING

    Genova, Italy

  • Royal Melbourne Hospital

    RECRUITING

    Melbourne, Victoria, 3050, Australia

  • Samsung Medical Center

    COMPLETED

    Seoul, South Korea

  • Seoul St. Marys Hospital, The Catholic University of Korea

    RECRUITING

    Seoul, South Korea

  • Soonchunhyang University Seoul Hospital

    RECRUITING

    Seoul, South Korea

  • St James Hospital,Leeds

    RECRUITING

    Leeds, United Kingdom

  • St. Vincents Hospital Melbourne

    RECRUITING

    Fitzroy, Victoria, 3355, Australia

  • The Tweed Hospital

    RECRUITING

    Tweed Heads, New South Wales, 2485, Australia

  • United Lincolnshire Hospitals NHS Trust - Pilgrim Hospital

    RECRUITING

    Boston, United Kingdom

  • University College London

    RECRUITING

    London, United Kingdom

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