What is momelotinib studying for low-risk myelodysplastic syndromes?

Momelotinib is being studied to see if it is safe and effective in improving anemia for people with low-risk myelodysplastic syndromes who require red blood cell transfusions. The trial, sponsored by GlaxoSmithKline, also looks at how the body processes the drug. Participants receive different doses to find the best treatment level.

Who may be eligible for this low-risk myelodysplastic syndromes clinical trial?

Adults aged 18 years or older with a diagnosis of low-risk myelodysplastic syndromes and anemia requiring red blood cell transfusions may be eligible. Both males and females can participate if they meet specific health and treatment history criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this low-risk myelodysplastic syndromes clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should consider their own travel arrangements when joining.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06847867

A Phase 2, Randomized, Open-label Study of Momelotinib in Participants With Anemia Due to Low-risk Myelodysplastic Syndrome

Led by GlaxoSmithKline · Updated on 2026-06-02

Participants Needed

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older or legal age of consent at the time of informed consent.
Documented diagnosis of myelodysplastic syndrome (MDS) with very low, low, or intermediate risk by Revised International Prognostic Scoring System (IPSS-R) and bone marrow blasts less than 5%.
Received only one prior treatment line with erythropoiesis-stimulating agents (ESA) or luspatercept for anemia related to low-risk MDS that is relapsed or refractory.
Red blood cell transfusion dependence requiring at least 3 units over a 16-week period in at least 2 transfusion episodes.
Female participants must not be pregnant or breastfeeding and must be either of non-childbearing potential or using contraception if of childbearing potential.
Capable of providing signed informed consent.
Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
Adequate organ function as defined by the study.

You will not qualify if you...

Prior treatment with Janus kinase (JAK)1/2 inhibitors, ACVR1 inhibitors, ACTRII receptor ligand traps other than luspatercept, hypomethylating agents, immunosuppressive therapy for MDS, recent ESA, growth factors, luspatercept, investigational agents, corticosteroids, or other active anti-MDS therapies within specified time periods.
Prior allogeneic or autologous stem cell transplant.
Major surgery within 28 days before randomization.
Ongoing adverse reactions from prior therapy not recovered to Grade 1 or baseline.
MDS with del 5q cytogenetic abnormality.
MDS/myeloproliferative neoplasm overlap disorders.
Secondary MDS from chemical injury or prior chemotherapy/radiation.
History of acute myeloid leukemia.
Clinically significant anemia due to iron, vitamin B12, folate deficiencies, autoimmune or hereditary hemolytic anemia, gastrointestinal bleeding, or thalassemia.
Diagnosis or recent history of invasive malignancy within 5 years except certain treated cancers.
Uncontrolled infections, bleeding, liver disease, or significant cardiac conditions within 6 months.
QTc interval greater than 480 milliseconds.
Psychiatric, social, or other conditions limiting compliance.
Peripheral neuropathy Grade 2 or higher.
Known HIV positive status.
Active hepatitis B or C infection.
Gastrointestinal conditions affecting absorption.
Unable to swallow or retain oral medications.
Known allergy to momelotinib or its components.

Research Team

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Center

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