NCT06517875

Brief Summary

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
23mo left

Started Feb 2025

Typical duration for phase_2

Geographic Reach
6 countries

33 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Feb 2025Mar 2028

First Submitted

Initial submission to the registry

July 19, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

February 28, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2027

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2028

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

July 19, 2024

Last Update Submit

April 17, 2026

Conditions

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

Keywords

Momelotinib; Luspatercept; Primary Myelofibrosis; Secondary Myelofibrosis; JAK inhibitor; anemia transfusion; Ojjara; Omjjara; Reblozyl

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants with TI Response by Week 24

    TI response is defined as not requiring red blood cell (RBC) transfusion (except in the case of clinically overt bleeding) for any ≥12-week interval.

    Up to Week 24

Secondary Outcomes (5)

  • Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation

    Up to approximately 36 weeks

  • Number of Participants with Clinically Important Changes in Laboratory Parameters, Vital Signs, and Eastern Cooperative Oncology Group (ECOG) Performance Status

    Up to Week 24

  • Percentage of Participants with TI at the End of Week 24

    Up to Week 24

  • Plasma Concentration of MMB

    Up to Week 24

  • Plasma Concentration of Morpholino Lactam (M21)

    Up to Week 24

Study Arms (1)

Momelotinib + Luspatercept

EXPERIMENTAL

Participants with transfusion dependent primary myelofibrosis or post- PV/ ET myelofibrosis that is JAKi naïve or JAKi experienced will receive momelotinib and luspatercept.

Drug: MomelotinibDrug: Luspatercept

Interventions

LuspaterceptDRUG

Luspatercept will be administered subcutaneously.

Also known as: REBLOZYL; ACE-536
Momelotinib + Luspatercept
MomelotinibDRUG

Momelotinib will be administered orally.

Also known as: Ojjaara; CYT387
Momelotinib + Luspatercept

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Is age ≥18 years.
  • Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016 criteria, or Post-PV/ET myelofibrosis in accordance with the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria.
  • JAKi naïve or previously treated with either ruxolitinib or fedratinib for PMF or Post-PV/ET myelofibrosis for ≥90 days, or ≥28 days if JAKi therapy is complicated by RBC transfusion requirement of ≥4 units in 8 weeks, or Grade 3/4 AEs of thrombocytopenia, anemia, or hematoma.
  • High risk, intermediate-2, or intermediate-1 risk as defined by Dynamic International Prognostic Scoring System (DIPSS) \[Passamonti, 2010\] or DIPSS-plus \[Gangat, 2011\].
  • TD defined as requiring RBC transfusion ≥4 units or HgB \< 8 g/dL in the 8 weeks prior to the first dose of study treatment (NOTE: 2 consecutive Hgb \< 8 g/dL, at least 1 week apart are required; Hgb values impacted by transfusions are excluded). Only transfusions given when Hgb levels are ≤9.5 g/dL are counted towards TD. RBC transfusions given for clinically overt bleeding, or accident/injury (as assessed by the investigator) are not counted towards TD.

You may not qualify if:

  • History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study intervention or result in inability to swallow oral medications.
  • Participants with an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years.
  • Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, gastrointestinal bleeding, or thalassemia.
  • Uncontrolled intercurrent illness:
  • Active uncontrolled infection (participants receiving outpatient antibacterial and/or antiviral treatments for infection that is under control or as infection prophylaxis may be included in the trial);
  • Significant active or chronic bleeding event ≥ Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, within 4 weeks prior to the first dose of study treatment; or
  • Uncontrolled acute and chronic liver disease (e.g., Child-Pugh score ≥10) OR has current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. NOTE: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) is acceptable if participant otherwise meets entry criteria.
  • Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, that is not resolved at the time of the first dose of study treatment.
  • Any of the following in conditions within 6 months prior to the first dose of study intervention:
  • Unstable angina pectoris; OR
  • Symptomatic congestive heart failure; OR
  • Uncontrolled cardiac arrhythmia
  • QTc interval \>450 msec or QTc \>480 msec for participants with bundle branch block.
  • Participants with stroke, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to the first dose of study intervention.
  • History of porphyria.
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

GSK Investigational Site

Ann Arbor, Michigan, 48109, United States

RECRUITING

GSK Investigational Site

New York, New York, 10032, United States

RECRUITING

GSK Investigational Site

Nashville, Tennessee, 37203, United States

RECRUITING

GSK Investigational Site

Houston, Texas, 77030, United States

RECRUITING

GSK Investigational Site

Seattle, Washington, 98109, United States

RECRUITING

GSK Investigational Site

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

GSK Investigational Site

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

GSK Investigational Site

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

GSK Investigational Site

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

GSK Investigational Site

Angers, 49933, France

RECRUITING

GSK Investigational Site

Brest, 29609, France

RECRUITING

GSK Investigational Site

Lyon, 69004, France

RECRUITING

GSK Investigational Site

Nice, 06202, France

RECRUITING

GSK Investigational Site

Nîmes, 30029, France

RECRUITING

GSK Investigational Site

Paris, 75010, France

RECRUITING

GSK Investigational Site

Poitiers, 86021, France

RECRUITING

GSK Investigational Site

Essen, 45147, Germany

RECRUITING

GSK Investigational Site

Jena, 07747, Germany

RECRUITING

GSK Investigational Site

Lübeck, 23538, Germany

RECRUITING

GSK Investigational Site

Mannheim, 68167, Germany

RECRUITING

GSK Investigational Site

Bologna, 40138, Italy

RECRUITING

GSK Investigational Site

Catania, 95123, Italy

RECRUITING

GSK Investigational Site

Florence, 50134, Italy

RECRUITING

GSK Investigational Site

Meldola FC, 47014, Italy

RECRUITING

GSK Investigational Site

Milan, 20122, Italy

RECRUITING

GSK Investigational Site

Roma, 161, Italy

RECRUITING

GSK Investigational Site

Badalona, 08005, Spain

RECRUITING

GSK Investigational Site

Barcelona, 8035, Spain

RECRUITING

GSK Investigational Site

Las Palmas, 35020, Spain

RECRUITING

GSK Investigational Site

Madrid, 28009, Spain

RECRUITING

GSK Investigational Site

Madrid, 28034, Spain

RECRUITING

GSK Investigational Site

Málaga, 29010, Spain

RECRUITING

GSK Investigational Site

Valencia, 46026, Spain

RECRUITING

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamideluspatercept

Condition Hierarchy (Ancestors)

Myeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2024

First Posted

July 24, 2024

Study Start

February 28, 2025

Primary Completion (Estimated)

March 19, 2027

Study Completion (Estimated)

March 17, 2028

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(4)ES(7)IT(6)US(5)FR(7)DE(4)