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

Sponsor
United Lincolnshire Hospitals NHS Trust
Study ID
NCT07424950
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • bomedemstat — DRUG
    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)

Study Details

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.

Key Dates

First listed
Feb 20, 2026
Start date
Nov 1, 2026
Status verified
Feb 2026
Primary completion
Nov 1, 2028
Completion
Nov 1, 2029

Study Design

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

Arms

  • Experimental: Bomedemstat + Momelotinib
    Bomedemstat + Momelotinib

Primary Outcome Measure

SVR35 at Week 24 [ Time Frame: 24 weeks ]

Central Contacts

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