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New treatment option for Myelodysplastic Syndromes
Official title A Study of TAK-226 for Anemia in Japanese Patients With Lower-Risk Myelodysplastic Syndromes
ClinicalTrials.gov ID: NCT07319845
What this study is testing
What is TAK-226?
TAK-226 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for myelodysplastic syndromes.
Also referred to as Elritercept, KER-050.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main aim of the study is to evaluate how TAK-226 improves symptoms of transfusion-dependent anemia in Japanese patients with lower-risk myelodysplastic syndromes. The study consists of Screening Period (up to 6 weeks), Treatment Period, Safety Follow-Up Period (8 weeks), and Long-Term Follow-Up Period (5 years from the first dose of the study drug or 3 years after the last dose, whichever is longer).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants or their legally authorized representative must be willing and able to sign the ICF and to adhere to the protocol requirements.
- Japanese adult male or female participant \>=18 years of age at the time of signing informed consent.
- Diagnosis of MDS with or without ring sideroblasts (RS) (as determined in an evaluable bone marrow aspirate collected at Screening to confirm...
- TD[YY1.1] cohort: Transfusion dependence assessed in the 16 weeks immediately preceding enrollment in two 8-week blocks classified as either:
- Low-transfusion burden (LTB), defined as 4 to 7 RBC units per 16 weeks; or
You likely can't join if
- Medical History
- Del(5q) MDS or therapy-related (secondary) MDS.
- Anemia due to any other known cause (eg, 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 in TD cohort or 8 weeks in NTD cohort before enrollment.
- Clinically significant cardiovascular disease defined as:
- New York Heart Association heart disease class III or IV;
See the full eligibility criteria
Who can join
- Participants or their legally authorized representative must be willing and able to sign the ICF and to adhere to the protocol requirements.
- Japanese adult male or female participant \>=18 years of age at the time of signing informed consent.
- Diagnosis of MDS with or without ring sideroblasts (RS) (as determined in an evaluable bone marrow aspirate collected at Screening to confirm diagnosis) according to WHO 2016 classification that meets the International...
- TD[YY1.1] cohort: Transfusion dependence assessed in the 16 weeks immediately preceding enrollment in two 8-week blocks classified as either:
- Low-transfusion burden (LTB), defined as 4 to 7 RBC units per 16 weeks; or
- HTB[YY2.1], defined as \>=8 RBC units per 16 weeks; and
- For all participants: i. Only transfusion events for a pretransfusion Hgb \ =7 days within the 16-week period immediately preceding enrollment; and iii. No consecutive 56-day period can be RBC transfusion-free during...
- TD cohort: Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued \>=4 weeks before enrollment), or unlikely to respond to ESA treatment, defined as follows: a. Refractory to...
- Less than 5% blasts in an evaluable bone marrow aspirate collected at Screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Women of childbearing potential (WOCBP), defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months must
- Agree to use 1 highly effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 60 days after the last dose of study drug; or
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal...
- Male participants must, even if he is surgically sterilized (ie, status postvasectomy),
- Agree to practice effective barrier contraception the time of signing the informed consent through 60 days after the last dose of study drug; or
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal...
What rules you out
- Medical History
- Del(5q) MDS or therapy-related (secondary) MDS.
- Anemia due to any other known cause (eg, 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 in TD cohort or 8 weeks in NTD cohort before enrollment.
- 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 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.
- 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 the participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for \>=5 years. However...
- 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 antibiotics within 28 days or oral antibiotics within 14 days before enrollment.
- History of or known active or chronic infection with HIV, active infectious hepatitis B virus (HBV), or active infectious hepatitis C virus (HCV). Participants who are positive for hepatitis B surface antigen (HBsAg)...
- Body mass index \>=40 kg/m\^2.
- Major surgery within 28 days before enrollment.
- History of allergy/anaphylaxis to investigational medicinal product (IMP) excipients (refer to the current elritercept [TAK 226] IB for a list of excipients) or recombinant proteins. Treatment History
- TD cohort: Prior use of TAK 226, luspatercept, imetelstat, or sotatercept. [YY4.1] NTD cohort: Prior use of TAK 226, luspatercept, imetelstat, sotatercept, or ESAs. Note for NTD cohort: At the investigator's discretion...
- Prior use of hypomethylating agents (HMAs), isocitrate dehydrogenase inhibitor, lenalidomide, or immunosuppressive therapy given for treatment of MDS.
- Iron chelation therapy initiated within 8 weeks before enrollment. Participants on stable doses of iron chelation therapy for \>=8 weeks are allowed.
- Vitamin B12 or folate therapy initiated within 4 weeks before enrollment. 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 enrollment. Participants on stable androgen dosing for hypogonadism for \>=8 weeks are allowed.
- High-dose corticosteroid use within 4 weeks before enrollment. Participants on stable chronic steroid doses of prednisone/prednisolone \ =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 treatment clinical study. Laboratory Exclusions (during Screening)
- Serum EPO level \>500 U/L. Note: Due to expected impacts of transfusion on EPO levels, laboratory results from blood samples collected within the 14 days following an RBC transfusion cannot be used to evaluate serum EPO...
- Platelet count \>=450\ 10\^3/mcrL or \<=25\ 10\^3/mcrL. Note: Due to expected impacts of transfusion, laboratory results from blood samples collected within the 7 days following a platelet transfusion cannot be used to...
- Absolute neutrophil count \<=500/mcrL
- Serum AST or ALT \>=3\ the upper limit of normal (ULN).
- Total bilirubin \>=2\ ULN unless attributable to Gilbert syndrome.
- Ferritin \<=50 mcrg/L.
- Folate \<=2.0 ng/mL.
- Vitamin B12 \<=200 pg/mL.
- Estimated glomerular filtration rate \<30 mL/min/1.73m\^2 as determined by Japanese Society of Nephrology. Calculated by the correction formula for Japanese. a) a) eGFR=194\ (serum creatinine value)\^-1.094\...
- Pregnant or lactating female[YY5.1]. Note: Participants who may be in the very early stage of pregnancy based on the doctor's interview with a negative pregnancy test are excluded from the study. Participants who are...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tokyo, Bunkyo-ku, Japan
- Fukui, Eiheiji, Japan
- Hiroshima, Fukuyama, Japan
- Kanagawa, Isehara, Japan
- Fukuoka, Kitakyushu, Japan
- Hyōgo, Kobe, Japan
- Yamanashi, Kofu, Japan
- Ehime, Matsuyama, Japan
- Tochigi, Mibu, Japan
- Aichi, Nagoya, Japan
- Chiba, Narita, Japan
- Kanagawa, Sagamihara, Japan
- Osaka, Sakai, Japan
- Hokkaido, Sapporo, Japan
- Miyagi, Sendai, Japan
- Tokyo, Shinagawa-ku, Japan
- Fukuoka, Japan
- Gifu, Japan
- Nagasaki, Japan
- Okayama, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tokyo, Bunkyo-ku, Japan; Fukui, Eiheiji, Japan; Hiroshima, Fukuyama, Japan; Kanagawa, Isehara, Japan; Fukuoka, Kitakyushu, Japan; Hyōgo, Kobe, Japan and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.