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A Study of Elritercept Alone or Together With Ruxolitinib in Adults With Myelofibrosis | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

A Phase 2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KER-050 as Monotherapy or in Combination With Ruxolitinib in Participants With Myelofibrosis

NCT05037760•Takeda

View on ClinicalTrials.gov

Summary

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.

Detailed Description

Elritercept is an investigational therapeutic protein designed to increase red blood cell and platelet production by inhibiting the signaling of a subset of the transforming growth factor beta (TGF-ß) family of proteins to promote hematopoiesis. It is being developed for the treatment of low blood cell counts, or cytopenias including anemia and thrombocytopenia in participants with Myelodysplastic Syndrome (MDS) and Myelofibrosis (MF).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+23 more criteria

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.
+43 more criteria

Locations (46)

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

Key Dates

Start Date

December 16, 2021

Primary Completion Date

February 28, 2028

Completion Date

February 28, 2030

Last Updated

February 5, 2026

Enrollment

135

ESTIMATED participants

Conditions

Myelofibrosis

Interventions

Elritercept

DRUG

Ruxolitinib

DRUG

Contacts

Takeda Contact

CONTACT

+1-877-825-3327 medinfoUS@takeda.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

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