Actively Recruiting
A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome
Led by GlaxoSmithKline · Updated on 2026-04-22
80
Participants Needed
39
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of signing informed consent.
- Documented diagnosis of MDS with WHO classification and IPSS-R risk score 3.5 or less (very low, low, or intermediate risk).
- Prior treatment with erythropoiesis-stimulating agents (ESA) or luspatercept for LR-MDS anemia that is relapsed or refractory.
- Documentation of transfusion dependence, requiring average of 4 or more units of packed red blood cells over 8 weeks in the 16 weeks before randomization.
- Female participants must not be pregnant or breastfeeding and either be of non-childbearing potential or use contraception if of childbearing potential.
- Able to give signed informed consent.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Adequate organ function as determined by study criteria.
You will not qualify if you...
- Prior treatment with JAK1/2 inhibitors, ACTRIIb receptor ligand traps (except luspatercept), hypomethylating agents, IMiDs, immunosuppressive therapy, erythropoiesis-stimulating agents within 4 weeks (8 weeks for long-acting ESA), growth factors within 4 weeks, luspatercept within 8 weeks, investigational agents within 4 weeks or 5 half-lives, corticosteroids for underlying disease within 28 days (except stable low-dose steroids for non-MDS reasons), other active anti-MDS therapy within 28 days or 5 half-lives, and potent CYP3A4 inducers within 14 days prior to first momelotinib dose.
- Prior allogeneic or autologous stem cell transplant.
- Major surgery within 28 days prior to randomization.
- Ongoing adverse reactions from prior therapy not resolved to Grade 1 or baseline.
- MDS with del 5q cytogenetic abnormality.
- Secondary MDS from chemical injury, chemotherapy, or radiation.
- Diagnosis or history of acute myeloid leukemia.
- Significant anemia due to iron, B12, folate deficiencies, autoimmune or hereditary hemolytic anemia, gastrointestinal bleeding, or thalassemia.
- Diagnosis or history of invasive malignancy within 5 years except certain treated cancers.
- Uncontrolled infections or significant bleeding within 4 weeks prior to randomization.
- Uncontrolled liver disease or unstable liver/biliary disease.
- Unstable angina, symptomatic heart failure, uncontrolled arrhythmia within 6 months prior to randomization.
- QTc interval over 480 msec.
- Psychiatric or social conditions limiting compliance.
- Peripheral neuropathy Grade 2 or higher.
- Known HIV infection.
- Active hepatitis A, B, or C infection.
- Clinically significant gastrointestinal conditions affecting absorption.
- Unable to swallow or retain oral medications.
- Known allergy or intolerance to momelotinib or its components.
AI-Screening
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Trial Site Locations
Total: 39 locations
1
GSK Investigational Site
Goodyear, Arizona, United States, 85338
Actively Recruiting
2
GSK Investigational Site
Duarte, California, United States, 91010-3012
Actively Recruiting
3
GSK Investigational Site
Irvine, California, United States, 92618
Actively Recruiting
4
GSK Investigational Site
New Haven, Connecticut, United States, 06519-1110
Actively Recruiting
5
GSK Investigational Site
Canton, Ohio, United States, 44718
Actively Recruiting
6
GSK Investigational Site
Houston, Texas, United States, 77030
Actively Recruiting
7
GSK Investigational Site
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
8
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
9
GSK Investigational Site
Le Mans, Sarthe, France, 72000
Actively Recruiting
10
GSK Investigational Site
Nice, France, 06202
Actively Recruiting
11
GSK Investigational Site
Paris, France, 75010
Actively Recruiting
12
GSK Investigational Site
Poitiers, France, 86021
Actively Recruiting
13
GSK Investigational Site
Toulouse, France, 31059
Actively Recruiting
14
GSK Investigational Site
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
15
GSK Investigational Site
Dresden, Germany, 01307
Actively Recruiting
16
GSK Investigational Site
Leipzig, Germany, 04103
Actively Recruiting
17
GSK Investigational Site
Udine, Friuli Venezia Giulia, Italy, 33100
Actively Recruiting
18
GSK Investigational Site
Rozzano, Milan, Italy, 20089
Actively Recruiting
19
GSK Investigational Site
Catania, Italy, 95123
Actively Recruiting
20
GSK Investigational Site
Florence, Italy, 50134
Actively Recruiting
21
GSK Investigational Site
Milan, Italy, 20122
Actively Recruiting
22
GSK Investigational Site
Orbassano to, Italy, 10043
Actively Recruiting
23
GSK Investigational Site
Katowice, Poland, 40-523
Actively Recruiting
24
GSK Investigational Site
Warsaw, Poland, 02-172
Actively Recruiting
25
GSK Investigational Site
Seongnam-si Gyeonggi-do, South Korea, 13620
Actively Recruiting
26
GSK Investigational Site
Seoul, South Korea, 03080
Actively Recruiting
27
GSK Investigational Site
Seoul, South Korea, 05505
Actively Recruiting
28
GSK Investigational Site
Seoul, South Korea, 06591
Actively Recruiting
29
GSK Investigational Site
Barcelona, Spain, 8035
Actively Recruiting
30
GSK Investigational Site
Barcelona, Spain, 8907
Actively Recruiting
31
GSK Investigational Site
Madrid, Spain, 28027
Actively Recruiting
32
GSK Investigational Site
Málaga, Spain, 29010
Actively Recruiting
33
GSK Investigational Site
Ourense, Spain, 032005
Actively Recruiting
34
GSK Investigational Site
PamplonaNavarra, Spain, 31008
Actively Recruiting
35
GSK Investigational Site
Salamanca, Spain, 37007
Actively Recruiting
36
GSK Investigational Site
Valencia, Spain, 46010
Actively Recruiting
37
GSK Investigational Site
Lincoln, United Kingdom, LN2 4AX
Actively Recruiting
38
GSK Investigational Site
London, United Kingdom, SE5 9RS
Actively Recruiting
39
GSK Investigational Site
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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