Actively Recruiting
Phase 2 Study of Momelotinib for Treating Anemia in Adults With Low-risk Myelodysplastic Syndrome
Led by GlaxoSmithKline · Updated on 2026-06-02
80
Participants Needed
39
Research Sites
24 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating momelotinib in adults with low-risk myelodysplastic syndromes LR-MDS who have anemia requiring red blood cell transfusions. The study aims to find out if momelotinib is safe and effective by testing different doses and observing how the body processes the drug. This is a Phase 2, randomized, open-label trial sponsored by GlaxoSmithKline focusing on patients with specific risk classifications of MDS and transfusion needs. Participants will receive momelotinib at one of two dose levels to determine the optimal dose. The study involves monitoring drug levels in the blood and assessing changes in red blood cell transfusion requirements. The treatment period lasts up to 24 weeks for primary outcomes, with extended safety and response monitoring continuing for up to approximately 133 weeks. Throughout the trial, participants will have regular evaluations including blood tests, assessments of anemia improvement, and monitoring for any side effects or adverse events. The main outcomes measured include the percentage of participants achieving transfusion independence for at least 12 weeks and safety events related to treatment. Participants will be followed for up to about 2.5 years to evaluate long-term effects and drug processing in the body.
CONDITIONS
Brief Title
A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
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