Not Yet RecruitingPhase 2

A Study of TAK-226 for Transfusion-Dependent Anemia in Japanese Patients With Lower-Risk Myelodysplastic Syndromes

27 participantsStarted 2026-02-06

Plain-language summary

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). Participants of this study will be administered TAK-226 during Treatment Period. Subsequently, the participants will be monitored for side effects related to the study treatment during Safety Follow-Up Period and Long-Term Follow-Up Period. The approximate duration of participation for a participant is up to approximately 6 years. During the study period, participants will visit the study clinic/hospital multiple times as per the study schedule. During Treatment Period, the participants will come to the clinic/hospital approximately every two to four weeks.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 RS (as determined in an evaluable bone marrow aspirate collected at Screening to confirm diagnosis) 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 enrollment in two 8-week blocks classified as either:
✓. Refractory or intolerant to prior ESA treatment (discontinued ≥4 weeks before enrollment), or unlikely to respond to ESA treatment, defined as follows:
✓. Less than 5% blasts in an evaluable bone marrow aspirate collected at Screening.
✓. 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

Exclusion criteria

What they're measuring

Percentage of Participants Achieving Transfusion Independence (TI) for Greater Than or Equal to 8 Weeks from Baseline through Week 24

Timeframe: Baseline, Up to Week 24

Trial details

NCT IDNCT07319845

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-06-26

Contact for this trial

Takeda Contact

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

View on ClinicalTrials.gov More Myelodysplastic Syndromes trials