RecruitingPHASE2INTERVENTIONAL

A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome

This study is looking into a new medication called momelotinib for individuals diagnosed with low-risk myelodysplastic syndromes (LR-MDS). LR-MDS is a condition where your body doesn't make enough healthy blood cells. The main goals are to find out if momelotinib is safe to use and how well it works to reduce the need for red blood cell transfusions. Researchers will also explore how the drug is processed in the body. Different doses of momelotinib will be given to participants to help determine the most effective and safest amount. This research is important for finding new ways to help people living with LR-MDS manage their condition.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

Start

05 Jun 2025

Estimated completion

29 Dec 2027

Myelodysplastic Syndromes

What is this study about?

This study is about a new medicine called momelotinib. It's being tested for people who have a blood condition called low-risk myelodysplastic syndromes (LR-MDS). In LR-MDS, your body doesn't produce enough healthy red blood cells, which can make you feel tired and need blood transfusions. The researchers want to see if this new drug can help your body make more healthy red blood cells so you need fewer transfusions.

The main aim of this study is to find out if momelotinib is both safe to use and effective in treating LR-MDS. This means they will closely watch for any side effects and see if the drug helps improve your blood cell count and reduces your need for blood transfusions. They will also look at how your body handles the medicine, like how it's absorbed and processed.

Participants in the study will be given different amounts of momelotinib. This is done to help the researchers figure out which dose works best to improve your red blood cell levels and reduce transfusions, while also being as safe as possible. Finding new and better treatments for LR-MDS is important to help people live more comfortably and with fewer symptoms.

Key takeaways

This study is testing a new drug for low-risk myelodysplastic syndromes (LR-MDS).
Its main goal is to see if momelotinib is safe and reduces the need for blood transfusions.
You must have already tried one other treatment for your anaemia that wasn't fully effective.
You need to be receiving regular red blood cell transfusions to be considered.
Participation involves taking the study drug and regular health check-ups.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of low-risk myelodysplastic syndromes (LR-MDS). Your specific type of LR-MDS must be classified as very low, low, or intermediate risk, with a certain score of 3.5 or less, and have less than 5% abnormal cells in your bone marrow. This helps ensure the study focuses on people with a similar stage of the condition.

You should have already tried one other treatment for your anaemia (low red blood cell count) related to LR-MDS, such as ESA or luspatercept, and that treatment either didn't work well or you couldn't tolerate it. If you couldn't take those treatments, or if your doctor believes they wouldn't work for you, you might still be considered. Importantly, you must also be needing regular red blood cell transfusions, specifically at least 3 units of blood over a 16-week period before the study starts.

Women who could become pregnant must be using effective birth control during the study. You also need to be well enough to take part and be able to understand and sign the consent form. The study team will check all these details carefully to make sure the study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of low-risk myelodysplastic syndromes (LR-MDS)?
Have you already used one treatment for your LR-MDS anaemia that didn't work well or you couldn't tolerate?
Do you currently need regular blood transfusions (at least 3 units over 16 weeks)?
Are you able to understand and sign a consent form?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study drug, momelotinib. The exact number of visits and tests will be explained in detail by the study team, but generally, studies like this involve regular check-ups, blood tests, and sometimes other examinations to monitor your health and how the treatment is working. You will be given the study medication at specific times and doses as directed by the study doctor. The total duration of your involvement, including follow-up appointments after you stop taking the drug, will be clearly outlined to you. Throughout the study, the team will monitor your red blood cell counts, your need for transfusions, and any side effects you might experience.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to a new treatment, momelotinib, which could reduce your need for red blood cell transfusions and improve your symptoms of anaemia. However, like all medications, momelotinib may have side effects, some of which could be serious. The study team will explain all known risks and carefully monitor you throughout the trial. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (39)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

GSK Investigational Site
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Goodyear, United States· Recruiting
GSK Investigational Site
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Duarte, United States· Recruiting
GSK Investigational Site
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Irvine, United States· Recruiting
GSK Investigational Site
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New Haven, United States· Recruiting
GSK Investigational Site
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Canton, United States· Recruiting
GSK Investigational Site
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Houston, United States· Recruiting
GSK Investigational Site
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Calgary, Canada· Recruiting
GSK Investigational Site
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Toronto, Canada· Recruiting
GSK Investigational Site
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Le Mans, France· Recruiting
GSK Investigational Site
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Nice, France· Recruiting
GSK Investigational Site
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Paris, France· Recruiting
GSK Investigational Site
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Poitiers, France· Recruiting

Common questions

What is LR-MDS?

LR-MDS stands for low-risk myelodysplastic syndromes. It's a condition where your body doesn't produce enough healthy blood cells, especially red blood cells, which can lead to tiredness and the need for blood transfusions.

What is momelotinib?

Momelotinib is the new drug being tested in this study. Researchers want to see if it can help people with LR-MDS make more healthy red blood cells and reduce their need for transfusions.

Why are different doses being used?

Using different doses helps the doctors find the amount of momelotinib that works best to improve your red blood cells and reduce transfusions, while also being as safe as possible for patients.

Will I still receive my usual medical care?

Yes, joining a study does not affect your right to receive your usual medical care. You can withdraw from the study at any time.

What is a 'prior line of treatment'?

This means you've already tried one type of medicine for your LR-MDS-related anaemia, such as ESA or luspatercept, but it either didn't work well enough or caused problems for you.

How to find out more

US GSK Clinical Trials Call Center

gskclinicalsupporthd@gsk.com 877-379-3718 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.