A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions

Conditions

• Myelodysplastic Syndromes

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Elritercept — DRUG
  Elritercept (TAK-226, KER-050) administered subcutaneously every 4 weeks.
• Placebo — DRUG
  Elritercept (TAK-226, KER-050) matching-placebo administered subcutaneously every 4 weeks.

Study Details

The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.

Key Dates

Start date

May 6, 2025

Status verified

May 2026

Primary completion

May 1, 2028

Completion

May 1, 2032

Study Design

Enrollment

225 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Elritercept
  Participants will be administered elritercept (TAK-226, KER-050), subcutaneously every 4 weeks, up to 48 weeks or until the end of treatment period.
• Placebo Comparator: Placebo
  Participants will be administered elritercept (TAK-226, KER-050) matching-placebo, subcutaneously every 4 weeks, up to 48 weeks or until the end of treatment period.

Primary Outcome Measure

Percentage of Participants Achieving Transfusion Independence (TI) for ≥8 Weeks [ Time Frame: Baseline through Week 24 ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (23)

Find similar trials in Duarte, CA

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