Clinical Trials List
Protocol NumberKER-050-D301
NCT Number(ClinicalTrials.gov Identfier)NCT06499285
Not yet recruiting
2025-01-17 - 2032-06-14
Phase III
Recruiting6
ICD-10C88.8
Other malignant immunoproliferative diseases
ICD-10C94.40
Acute panmyelosis with myelofibrosis not having achieved remission
ICD-10C94.41
Acute panmyelosis with myelofibrosis, in remission
ICD-10C94.42
Acute panmyelosis with myelofibrosis, in relapse
ICD-10C94.6
Myelodysplastic disease, not classified
ICD-10D46.9
Myelodysplastic syndrome, unspecified
ICD-10D46.A
Refractory cytopenia with multilineage dysplasia
ICD-10D46.B
Refractory cytopenia with multilineage dysplasia and ring sideroblasts
ICD-10D46.C
Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality
ICD-10D46.Z
Other myelodysplastic syndromes
ICD-10D47.1
Chronic myeloproliferative disease
ICD-10D47.3
Essential (hemorrhagic) thrombocythemia
ICD-10D47.9
Neoplasm of uncertain behavior of lymphoid, hematopoietic and related tissue, unspecified
ICD-10D47.Z1
Post-transplant lymphoproliferative disorder (PTLD)
ICD-10D47.Z9
Other specified neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue
ICD-9238.7
Neoplasm of uncertain behavior of other lymphatic and hematopoietic tissues
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)
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Trial Applicant
TAIWAN PSI HEALTH DEVELOPMENT COMPANY LIMITED
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王元欽 無
- 高小雯 無
- 洪玉馨 無
- 蘇羿囷 無
- HSUAN JEN SHIH 無
- Tung-Liang Lin 無
- 張 鴻 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- - - Division of Hematology & Oncology
- MING YAO Division of Hematology & Oncology
- Huai-Hsuan Huang Division of Hematology & Oncology
- 李思慧 Division of Hematology & Oncology
- HSIN-AN HOU Division of Hematology & Oncology
- Tai-Chung Huang Division of Hematology & Oncology
- Shang-Ju Wu Division of Hematology & Oncology
- Chien-Chin Lin Division of Hematology & Oncology
- - - Division of Hematology & Oncology
- Chieh-Lung Cheng Division of Hematology & Oncology
- 田豐銘 Division of Hematology & Oncology
- 林明恩 Division of Hematology & Oncology
- YAO CHI-YUAN Division of Hematology & Oncology
- 楊鎰聰 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Tsai-Yun Chen
Co-Principal Investigator
- Ya-Ting Hsu Division of General Internal Medicine
- Sin-Syue Li Division of General Internal Medicine
- 傅蓓安 Division of General Internal Medicine
- Ya-Ping Chen Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
CHENG-HSIEN LIN
Co-Principal Investigator
- PO-HSIEN LI Division of Hematology & Oncology
- 滕傑林 無
- 鄧齡喬 Division of Hematology & Oncology
- Chieh-Lin Teng Division of Hematology & Oncology
- PO-WEI LIAO Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Myelodysplastic Syndromes
Objectives
Primary
• Evaluate the efficacy of elritercept in reducing red blood cell (RBC) transfusions
Secondary
• Evaluate the efficacy of elritercept in reducing RBC transfusions over a longer period, and/or in reducing RBC transfusions in participants with high transfusion burden (HTB)
• Evaluate the safety and tolerability of elritercept
Test Drug
注射液劑(無菌製備)
Active Ingredient
Elritercept
Dosage Form
27H
Dosage
100mg/mL
Endpoints
• The percentage of participants who achieved transfusion-free status (TI) ≥ 8 weeks from the base period to week 24.
Inclution Criteria
Inclusion 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:
a. Low-transfusion burden (LTB), defined as 4 to 7 red blood cells (RBC) units per 16 weeks; or b. High-transfusion burden (HTB), defined as ≥8 RBC units per 16 weeks; and c. For all participants: i. Only transfusion events for a pretransfusion hemoglobin (Hgb) lesser than (<)10 grams per deciliter (g/dL) are counted toward eligibility; ii. At least 1 transfusion event in each 8-week period and a minimum of 2 transfusion events separated by ≥7 days within the 16-week period immediately preceding randomization; and iii. No consecutive 56-day period can be RBC transfusion-free during the 16-week period immediately preceding randomization.
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:
a. Refractory to prior ESA treatment: documentation of nonresponse or a response that was no longer maintained with a prior ESA-containing regimen, either as a single agent or combination (e.g., with granulocyte colony-stimulating factor [G-CSF]); ESA regimen must have been either: i. Recombinant human erythropoietin (EPO) ≥40,000 international units per week (IU/week) for ≥8 doses or equivalent; or ii. Darbepoetin alpha ≥500 micrograms (μg) every 3 weeks for ≥4 doses or equivalent.
b. Intolerant to prior ESA treatment: documentation of discontinuation of a prior ESA-containing regimen, either as a single agent or combination (e.g., with G-CSF), at any time after introduction due to intolerance or an AE.
c. Unlikely to respond to ESA treatment: low chance of response to ESA based on an endogenous serum EPO level greater than (>)200 units per liter (U/L).
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).
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:
a. Low-transfusion burden (LTB), defined as 4 to 7 red blood cells (RBC) units per 16 weeks; or b. High-transfusion burden (HTB), defined as ≥8 RBC units per 16 weeks; and c. For all participants: i. Only transfusion events for a pretransfusion hemoglobin (Hgb) lesser than (<)10 grams per deciliter (g/dL) are counted toward eligibility; ii. At least 1 transfusion event in each 8-week period and a minimum of 2 transfusion events separated by ≥7 days within the 16-week period immediately preceding randomization; and iii. No consecutive 56-day period can be RBC transfusion-free during the 16-week period immediately preceding randomization.
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:
a. Refractory to prior ESA treatment: documentation of nonresponse or a response that was no longer maintained with a prior ESA-containing regimen, either as a single agent or combination (e.g., with granulocyte colony-stimulating factor [G-CSF]); ESA regimen must have been either: i. Recombinant human erythropoietin (EPO) ≥40,000 international units per week (IU/week) for ≥8 doses or equivalent; or ii. Darbepoetin alpha ≥500 micrograms (μg) every 3 weeks for ≥4 doses or equivalent.
b. Intolerant to prior ESA treatment: documentation of discontinuation of a prior ESA-containing regimen, either as a single agent or combination (e.g., with G-CSF), at any time after introduction due to intolerance or an AE.
c. Unlikely to respond to ESA treatment: low chance of response to ESA based on an endogenous serum EPO level greater than (>)200 units per liter (U/L).
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).
Exclusion Criteria
Exclusion Criteria:
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:
New York Heart Association heart disease class III or IV;
Fridericia corrected QT (QTcF) interval >500 milliseconds during Screening;
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
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:
Basal or squamous cell carcinoma of the skin;
Carcinoma in situ of the cervix;
Carcinoma in situ of the breast; and/or
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]).
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:
New York Heart Association heart disease class III or IV;
Fridericia corrected QT (QTcF) interval >500 milliseconds during Screening;
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
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:
Basal or squamous cell carcinoma of the skin;
Carcinoma in situ of the cervix;
Carcinoma in situ of the breast; and/or
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]).
The Estimated Number of Participants
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Taiwan
8 participants
-
Global
225 participants
