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Bomedemstat (IMG-7289) in Combination With Momelotinib in Patients With Myelofibrosis

NCT07424950 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-20

No results posted yet for this study

Summary

This is an open-label, single-arm, Phase 2 interventional study designed to evaluate the safety and efficacy of Bomedemstat (IMG-7289) when added to Momelotinib in patients with Myelofibrosis (MF) who exhibit a suboptimal response to Momelotinib alone or who present with baseline cytopenias and do not achieve adequate improvement after 12 weeks of Momelotinib monotherapy.

The study consists of three phases:

1. Screening Phase (up to 28 days)
2. Momelotinib Monotherapy Phase - Weeks 0-12
3. Combination Treatment Phase (Momelotinib + Bomedemstat) - Weeks 12-24
4. Post-Treatment Follow-up Phase (30 days post last dose + long-term survival follow-up) All patients will continue on Momelotinib throughout the study unless toxicity or safety considerations necessitate modification.

Conditions

Interventions

DRUG

bomedemstat

Screening (≤ 28 days) ↓ Momelotinib Alone (Weeks 0-12) * Week 12 Response Assessment If Suboptimal → Add Bomedemstat 50 mg QD Combination Phase (Weeks 12-24) ↓ Week 24 Primary Endpoint Assessment ↓ Safety Follow-Up (30 days post last dose) ↓ Long-Term Follow-Up (q12 weeks for 12 months)

Sponsors & Collaborators

  • University of Lincoln

    collaborator OTHER

  • United Lincolnshire Hospitals NHS Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-01
Primary Completion
2028-11-01
Completion
2029-11-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07424950 on ClinicalTrials.gov