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

Sponsor
Takeda
Study ID
NCT07319845
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TAK-226 — DRUG
    TAK-226 subcutaneous injection

Study Details

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.

Key Dates

First listed
Jan 6, 2026
Start date
Apr 22, 2026
Status verified
Jul 2026
Primary completion
Jun 26, 2028
Completion
Jan 10, 2033

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TAK-226
    Participants will receive the study drug, TAK-226, administered subcutaneously every four weeks (Q4W) for approximately one year during Treatment Period.

Primary Outcome Measure

Transfusion dependent (TD) cohort: Percentage of Participants Achieving Transfusion Independence (TI) for Greater Than or Equal to (>=) 8 Weeks from Baseline through Week 24 [ Time Frame: Baseline, Up to Week 24 ]

Central Contacts

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