Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
GlaxoSmithKline
Study ID
NCT06517875
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
  • Primary Myelofibrosis

Eligibility Criteria

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

Interventions

  • Momelotinib — DRUG
    Momelotinib will be administered orally.
  • Luspatercept — DRUG
    Luspatercept will be administered subcutaneously.

Study Details

The purpose of this Phase 2 study is to evaluate the efficacy and safety of momelotinib (MMB) in combination with luspatercept (LUSPA) in participants with transfusion dependence (TD) primary myelofibrosis (PMF) or Post-polycythemia vera (PV)/ essential thrombocythemia (ET) myelofibrosis (MF) who are either janus kinase (JAK) inhibitor (JAKi) naïve or experienced.

Key Dates

Start date
Feb 28, 2025
Status verified
Apr 2026
Primary completion
Mar 19, 2027
Completion
Mar 17, 2028

Study Design

Enrollment
68 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Momelotinib + Luspatercept
    Participants with transfusion dependent primary myelofibrosis or post- PV/ ET myelofibrosis that is JAKi naïve or JAKi experienced will receive momelotinib and luspatercept.

Primary Outcome Measure

Percentage of Participants with TI Response by Week 24 [ Time Frame: Up to Week 24 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteAnn ArborMichigan48109
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Kristen Pettit (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteNew YorkNew York10032
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 Chernak (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteNashvilleTennessee37203
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Jonathan Abbas (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
Prithviraj Bose (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteSeattleWashington98109
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Vivian Oehler (PRINCIPAL_INVESTIGATOR)

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GSK Investigational Site· Ann Arbor, MIGSK Investigational Site· New York, NYGSK Investigational Site· Nashville, TNGSK Investigational Site· Houston, TXGSK Investigational Site· Seattle, WA

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