80 Participants Needed

Momelotinib for Myelodysplastic Syndrome

(MIDAS Trial)

UG
EG
Overseen ByEU GSK Clinical Trials Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to determine if momelotinib is safe and effective for people with low-risk myelodysplastic syndromes (LR-MDS). The trial will also examine how the body processes the drug. The study is comprised of two parts: Part 1: Participants will receive different doses of momelotinib to find the best dose by evaluating effectiveness in improving red blood cell transfusion requirements and safety. Part 2: Participants will receive dose selected from Part 1 to assess its impact on improving red blood cell transfusion requirements and safety in LR-MDS.

Are You a Good Fit for This Trial?

Inclusion Criteria

I can sign and understand the consent form.
My organs are working well.
I stopped my previous ESA or luspatercept treatment due to side effects.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive different doses of momelotinib to find the best dose by evaluating effectiveness in improving red blood cell transfusion requirements and safety

24 weeks

Treatment Part 2

Participants receive the dose selected from Part 1 to assess its impact on improving red blood cell transfusion requirements and safety in LR-MDS

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Momelotinib
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Part 2- Dose Exploration: MomelotinibExperimental Treatment1 Intervention
Group II: Part 1- Dose Optimisation: MomelotinibExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
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Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

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