NCT04419649 A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)
| NCT ID | NCT04419649 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Takeda |
| Condition | Myelodysplastic Syndromes |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2020-08-19 |
| Primary Completion | 2029-10-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The main aim of this study is to learn how safe elritercept is and how well adults with anemia associated with lower-risk MDS tolerate treatment with different doses of elritercept. Other aims are to learn how safe elritercept is by looking at how many participants have MDS that worsens during the study and learn about the effects of elritercept on anemia linked to MDS. The study will also look to learn how elritercept affects the production of healthy RBCs.
Eligibility Criteria
Inclusion Criteria: 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local study participant privacy regulations. 2. Male or female ≥ 18 years of age, at the time of signing informed consent. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia). 4. Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception. 5. 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). Part 1 Inclusion Criteria Participants are eligible to be included in Part 1 of the study only if all the following criteria apply: 1. Diagnosis of MDS according to WHO classification that meets International Prognostic Scoring System-Revised (IPSS-R) class