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

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
GlaxoSmithKline
Study ID
NCT06847867
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Momelotinib — DRUG
    Momelotinib will be administered.

Study Details

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

Key Dates

Start date
Jun 5, 2025
Status verified
May 2026
Primary completion
Jul 14, 2027
Completion
Dec 29, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Momelotinib dose level 1
  • Experimental: Momelotinib dose level 2

Primary Outcome Measure

Percentage of participants with Red Blood Cells - transfusion independence (RBC-TI) for at least 12 weeks, rolling over 24 weeks [ Time Frame: Up to 24 weeks ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteGoodyearArizona85338
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Zawit Misam (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteDuarteCalifornia91010-3012
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Brian Ball (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteIrvineCalifornia92618
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Brian Ball (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteNew HavenConnecticut06519-1110
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Amer Zeidan (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteCantonOhio44718
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Nashat Gabrail (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteHoustonTexas77030
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Guillermo Garcia-Manero (PRINCIPAL_INVESTIGATOR)

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