CTRI/2026/02/104956招募中3 期
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)
Takeda Development Center Americas Inc12 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2026年3月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 225
- 试验地点
- 12
研究概览
简要总结
The purpose of this study is to determine whether Elritercept is a safe and effective treatment for Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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 according to WHO 2016 classification that meets the IPSS-R classification of very low-, low-, or intermediate-risk MDS.
- •Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either a.
- •LTB, defined as 4 to 7 RBC units per 16 weeks b.
- •HTB, defined as greater than or equal to 8 RBC units per 16 weeks c.
- •For all participants i.
- •Only transfusion events for a pretransfusion Hgb less than 10 g per 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 greater than or equal to 7 days within the 16-week period immediately preceding randomization iii.
- •No consecutive 56-day period can be RBC transfusion-free during the 16-week period immediately preceding randomization.
- •Refractory or intolerant to prior ESA treatment (discontinued greater than or equal to 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- •Refractory to prior ESA treatment documentation of nonresponse or a response that was no longer maintained with a prior ESA-containing regimen, either as a single agent or combination (e.g., with granulocyte colony-stimulating factor (G CSF)) ESA regimen must have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 EPO greater than or equal to 40,000 IU per week for greater than or equal to 8 doses or equivalent ii.
- •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.
- •Unlikely to respond to ESA treatment low chance of response to ESA based on an endogenous serum EPO level greater than 200 U per L.
- •Less than 5 percent blasts in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader.
- •ECOG performance status of 0 to 2
- •Females of childbearing potential and sexually active males must agree to use adequate contraception methods
- •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).
排除标准
- •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 a.
- •Fridericia corrected QT (QTcF) interval greater than 500 milliseconds during Screening c.
- •Presence of uncontrolled hypertension defined as mean systolic blood pressure greater than or equal to 160 mm Hg or diastolic blood pressure greater than or equal to 100 mm Hg during Screening d.
- •Uncontrolled arrhythmia, myocardial infarction, or unstable angina 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 AML.
- •Prior history of malignancies, other than MDS, unless the participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for greater than or equal 5 years.
- •However, participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy a.
- •Basal or squamous cell carcinoma of the skin b.
- •Carcinoma in situ of the cervix c.
- •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 or 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 greater than or equal 40 kg per m
- •Major surgery within 28 days before randomization.
- •History of allergy or anaphylaxis to investigational medicinal product (IMP) excipients (refer to the current elritercept IB for a list of excipients) or recombinant proteins.
- •Treatment History
- •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 greater than or equal 8 weeks are allowed.
- •Vitamin B12 or folate therapy initiated within 4 weeks before randomization.
- •Participants on stable replacement doses for greater than or equal 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 greater than or equal 8 weeks are allowed.
- •High-dose corticosteroid use within 4 weeks before randomization.
- •Participants on stable chronic steroid doses of prednisone less than or equal 10 mg per day or corticosteroid equivalent for greater than or equal 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 greater than 500 U per L.
- •Platelet count greater than or equal 450 × 109 per L or less than or equal 25 × 109 per L.
- •Absolute neutrophil count less than or equal 500 per micrograms L.
- •Serum aspartate aminotransferase or alanine aminotransferase greater than or equal to 3 × the upper limit of normal (ULN).
- •Ferritin less than or equal to 50 micrograms/L.
- •Vitamin B12 less than or equal 200 pg/mL.
- •Estimated glomerular filtration rate less than 30 mL per min per 1.73m2 as determined by the Chronic Kidney Disease Epidemiology (CKD-EPI) Collaboration equation Miscellaneous
- •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 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.
研究者
研究点 (12)
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