Phase 2 Study of TAK-226 Injection for Treating Anemia in Japanese Adults With Lower-Risk Myelodysplastic Syndromes

What this Trial Is About

Researchers are evaluating the effects of TAK-226 on symptoms of transfusion-dependent anemia in Japanese adults with lower-risk myelodysplastic syndromes MDS. This Phase 2, open-label study focuses on patients classified as very low, low, or intermediate risk according to a specific scoring system. The trial aims to understand how TAK-226 may improve anemia-related symptoms and reduce the need for blood transfusions in this population. Participants receive TAK-226 through subcutaneous injections every four weeks for about one year during the Treatment Period. The study begins with a Screening Period lasting up to six weeks to confirm eligibility. After treatment, participants enter an 8-week Safety Follow-Up Period to monitor side effects, followed by a Long-Term Follow-Up Period lasting up to five years from the first dose or three years after the last dose, whichever is longer. During the Treatment Period, participants visit the clinic approximately every two to four weeks. Throughout the study, participants undergo regular visits for assessments including blood tests and evaluations of hemoglobin levels and transfusion needs. Researchers will monitor various blood parameters and adverse events up to about six years. The primary outcomes focus on achieving transfusion independence or meaningful increases in hemoglobin over periods of up to 24 weeks. Overall, participants may be involved in the study for up to six years, allowing long-term observation of treatment effects and safety.

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