RECRUITING

A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions

Conditions

Myelodysplastic Syndromes Anemia Elritercept Myelodysplastic neoplasms KER-050 MDS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants With Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)

Quick Facts

Study Start:2025-05-06

Study Completion:2032-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06499285

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information and/or protected personal data in accordance with national and local study participant data protections and privacy regulations. * Male or female greater than or equal to (≥)18 years of age at the time of signing informed consent. * Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow aspirate, read by an independent central reader to confirm diagnosis at Screening) according to the World Health Organization 2016 classification that meets the International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease. * Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either: * Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to respond to ESA treatment, defined as follows: * Less than 5% blasts in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader. * Eastern Cooperative Oncology Group performance status of 0 to 2. * Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception. * 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).	* Del(5q) MDS or therapy-related (secondary) MDS. * Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and/or folate). * Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization. * Clinically significant cardiovascular disease defined as: 1. New York Heart Association heart disease class III or IV; 2. Fridericia corrected QT (QTcF) interval \>500 milliseconds during Screening; 3. Presence of uncontrolled hypertension defined as mean systolic blood pressure ≥160 millimeters of mercury (mm Hg) or diastolic blood pressure ≥100 mm Hg during Screening; or 4. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before Screening. * Known ejection fraction \<35%, confirmed by a local echocardiogram performed during Screening, or a previously performed echocardiogram if collected within 6 months before Screening. * Child-Pugh class C hepatic impairment. * Stroke, deep vein thrombosis, or pulmonary embolism within 6 months before Screening. * Any known history of acute myeloid leukemia (AML). * Prior history of malignancies, other than MDS, unless participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for ≥ 5 years. However, 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 tumor, node, metastasis \[TNM\] clinical staging system). * History of solid organ or bone marrow transplantation. * Active infection requiring intravenous treatment (e.g., antibiotics, antifungals, or antivirals) within 28 days, or oral treatment within 14 days before randomization. * History of or known active chronic infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines. * Body mass index ≥ 40 kilograms per meter square (kg/m\^2). * Major surgery within 28 days before randomization. * History of allergy/anaphylaxis to investigational medicinal product (IMP) excipients (refer to the current elritercept IB for a list of excipients) or recombinant proteins. * Prior use of elritercept, luspatercept, or sotatercept. * Prior use of hypomethylating agents (HMAs), isocitrate dehydrogenase inhibitor, lenalidomide, imetelstat, or immunosuppressive therapy given for treatment of MDS. * Iron chelation therapy initiated within 8 weeks before randomization. Participants on stable doses of iron chelation therapy for ≥ 8 weeks are allowed. * Vitamin B12 or folate therapy initiated within 4 weeks before randomization. Participants on stable replacement doses for ≥ 4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed. * Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥ 8 weeks are allowed. * High-dose corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone lesser than or equal to (≤) 10 mg/day or corticosteroid equivalent for ≥ 4 weeks are allowed.10 mg/day or corticosteroid equivalent for ≥ 4 weeks are allowed. * Treatment with any investigational drug within 28 days before Screening or, if the half-life of the product is known, within 5 times the half-life before Screening, whichever is longer. * Ongoing participation in another interventional clinical study. * Serum EPO level \>500 U/L. * Platelet count ≥450 × 10\^9/L or ≤25 × 10\^9/L. * Absolute neutrophil count ≤ 500/µL. * Serum aspartate aminotransferase or alanine aminotransferase ≥3 × the upper limit of normal (ULN). * Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome. * Ferritin ≤ 50 micrograms per litre (μg/L). * Folate ≤2.0 nanograms per milliliter (ng/mL). * Vitamin B12 ≤200 picograms per milliliter (pg/mL). * Estimated glomerular filtration rate \<30 milliliters per minute per 1.73 meter square (mL/min/1.73m\^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Collaboration equation. * Pregnant or lactating female. * Any other condition not specifically noted above that, in the opinion of the Investigator, would preclude the participant from participating in the study or could confound interpretation of data from the study. * Investigational site staff members directly involved in the conduct of the study and site staff members otherwise supervised by the Investigator, employees of the Sponsor or contract research organization (CRO) directly involved in the conduct of the study, or immediate family members (defined as a spouse, parent, child, or sibling, whether biological or legally adopted). * For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults (per applicable French law \[Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1\]).

Inclusion Criteria

Exclusion Criteria

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information and/or protected personal data in accordance with national and local study participant data protections and privacy regulations.
* Male or female greater than or equal to (≥)18 years of age at the time of signing informed consent.
* Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow aspirate, read by an independent central reader to confirm diagnosis at Screening) according to the World Health Organization 2016 classification that meets the International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease.
* Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either:
* Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to respond to ESA treatment, defined as follows:
* Less than 5% blasts in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader.
* Eastern Cooperative Oncology Group performance status of 0 to 2.
* Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception.
* 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).

* Del(5q) MDS or therapy-related (secondary) MDS.
* Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and/or folate).
* Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization.
* Clinically significant cardiovascular disease defined as:
1. New York Heart Association heart disease class III or IV;
2. Fridericia corrected QT (QTcF) interval \>500 milliseconds during Screening;
3. Presence of uncontrolled hypertension defined as mean systolic blood pressure ≥160 millimeters of mercury (mm Hg) or diastolic blood pressure ≥100 mm Hg during Screening; or
4. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before Screening.
* Known ejection fraction \<35%, confirmed by a local echocardiogram performed during Screening, or a previously performed echocardiogram if collected within 6 months before Screening.
* Child-Pugh class C hepatic impairment.
* Stroke, deep vein thrombosis, or pulmonary embolism within 6 months before Screening.
* Any known history of acute myeloid leukemia (AML).
* Prior history of malignancies, other than MDS, unless participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for ≥ 5 years. However, 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 tumor, node, metastasis \[TNM\] clinical staging system).
* History of solid organ or bone marrow transplantation.
* Active infection requiring intravenous treatment (e.g., antibiotics, antifungals, or antivirals) within 28 days, or oral treatment within 14 days before randomization.
* History of or known active chronic infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.
* Body mass index ≥ 40 kilograms per meter square (kg/m\^2).
* Major surgery within 28 days before randomization.
* History of allergy/anaphylaxis to investigational medicinal product (IMP) excipients (refer to the current elritercept IB for a list of excipients) or recombinant proteins.
* Prior use of elritercept, luspatercept, or sotatercept.
* Prior use of hypomethylating agents (HMAs), isocitrate dehydrogenase inhibitor, lenalidomide, imetelstat, or immunosuppressive therapy given for treatment of MDS.
* Iron chelation therapy initiated within 8 weeks before randomization. Participants on stable doses of iron chelation therapy for ≥ 8 weeks are allowed.
* Vitamin B12 or folate therapy initiated within 4 weeks before randomization. Participants on stable replacement doses for ≥ 4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.
* Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥ 8 weeks are allowed.
* High-dose corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone lesser than or equal to (≤) 10 mg/day or corticosteroid equivalent for ≥ 4 weeks are allowed.10 mg/day or corticosteroid equivalent for ≥ 4 weeks are allowed.
* Treatment with any investigational drug within 28 days before Screening or, if the half-life of the product is known, within 5 times the half-life before Screening, whichever is longer.
* Ongoing participation in another interventional clinical study.
* Serum EPO level \>500 U/L.
* Platelet count ≥450 × 10\^9/L or ≤25 × 10\^9/L.
* Absolute neutrophil count ≤ 500/µL.
* Serum aspartate aminotransferase or alanine aminotransferase ≥3 × the upper limit of normal (ULN).
* Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome.
* Ferritin ≤ 50 micrograms per litre (μg/L).
* Folate ≤2.0 nanograms per milliliter (ng/mL).
* Vitamin B12 ≤200 picograms per milliliter (pg/mL).
* Estimated glomerular filtration rate \<30 milliliters per minute per 1.73 meter square (mL/min/1.73m\^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Collaboration equation.
* Pregnant or lactating female.
* Any other condition not specifically noted above that, in the opinion of the Investigator, would preclude the participant from participating in the study or could confound interpretation of data from the study.
* Investigational site staff members directly involved in the conduct of the study and site staff members otherwise supervised by the Investigator, employees of the Sponsor or contract research organization (CRO) directly involved in the conduct of the study, or immediate family members (defined as a spouse, parent, child, or sibling, whether biological or legally adopted).
* For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults (per applicable French law \[Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1\]).

Contacts and Locations

Study Contact

Takeda Contact

CONTACT

+1-877-825-3327

medinfoUS@takeda.com

Principal Investigator

Study Director

STUDY_DIRECTOR

Takeda

Study Locations (Sites)

City of Hope

Duarte, California, 91010

United States

Los Angeles Cancer Network

Glendale, California, 91206

United States

UC San Diego Moores Cancer Center

La Jolla, California, 92037

United States

Smilow Cancer Hospital at Yale-New Haven

New Haven, Connecticut, 06511

United States

University of Miami Hospital and Clinics

Miami, Florida, 33136

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

ILCC. Illinois Cancer Centers

Peoria, Illinois, 61645

United States

Norton Cancer Institute

Louisville, Kentucky, 40207

United States

Johns Hopkins Hospital

Baltimore, Maryland, 21287

United States

Maryland Oncology Hematolofy

Columbia, Maryland, 21044

United States

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89169

United States

Clinical Research Alliance NY

Westbury, New York, 11590

United States

Gabrail Cancer Center Research

Canton, Ohio, 44718

United States

Cleveland Clinic - Cleveland

Cleveland, Ohio, 44195

United States

Tennessee Cancer Specialists

Knoxville, Tennessee, 37909

United States

Baptist Clinical Research Institute

Memphis, Tennessee, 38120

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Texas Oncology Northeast Texas

Denison, Texas, 75020

United States

U.T. MD Anderson Cancer Center, Division of Cancer Medicine

Houston, Texas, 77030

United States

Texas Oncology Gulf Coast

The Woodlands, Texas, 77380

United States

Tranquil Research

Webster, Texas, 77598-4085

United States

Collaborators and Investigators

Sponsor: Takeda

Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-06

Study Completion Date2032-05-01

Study Record Updates

Study Start Date2025-05-06

Study Completion Date2032-05-01

Terms related to this study

Keywords Provided by Researchers

Anemia
Elritercept
Myelodysplastic neoplasms
KER-050
MDS

Additional Relevant MeSH Terms

Myelodysplastic Syndromes