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

NCT07424950 | Not Yet Recruiting Phase 2

• 1 other identifier: 49027
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Screening Phase (up to 28 days)
2. 2.Momelotinib Monotherapy Phase - Weeks 0-12
3. 3.Combination Treatment Phase (Momelotinib + Bomedemstat) - Weeks 12-24
4. 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

Myelofibrosis

Keywords

myelofibrosis; bomedestat; momelotinib

Outcome Measures

Primary Outcomes (1)

• SVR35 at Week 24

  spleen value reduction by 35%

  24 weeks

Study Arms (1)

Bomedemstat + Momelotinib

EXPERIMENTAL

Bomedemstat + Momelotinib

Drug: bomedemstat

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)

Also known as: Momelotinib

Bomedemstat + Momelotinib

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female participants ≥18 years of age on the day of signing informed consent.
• \. Histologically confirmed diagnosis of:
• Primary Myelofibrosis (PMF), or
• Secondary MF following Polycythaemia Vera (post-PV MF), or
• Secondary MF following Essential Thrombocythaemia (post-ET MF) (as defined by WHO 2022 criteria) 3. Disease risk category:
• Intermediate-2 or High-risk MF according to DIPSS. 4. Cohort assignment (Investigator-defined; permitted insertion):
• Cohort 1 - Momelotinib-Experienced:
• Receiving Momelotinib 200 mg QD for ≥12 weeks prior to Week 12 assessment
• Demonstrates suboptimal response at Week 12 (definition below)
• Cohort 2 - Cytopenic MF:
• Baseline Hb \<10 g/dL and/or platelets \<100 × 10⁹/L
• Starting Momelotinib at Week 0
• Demonstrates suboptimal response at Week 12

You may not qualify if:

• Medical Conditions
• Known hypersensitivity to Bomedemstat or MAOIs
• Clinically significant GI conditions affecting absorption
• Increased bleeding risk
• Hereditary bleeding disorders
• Active or chronic bleeding within 8 weeks
• Autoimmune bleeding disorders
• Uncontrolled comorbidities
• Active secondary malignancies (with exceptions)
• HBV/HCV/HIV status not meeting template criteria
• Receipt of prohibited medications within 14 days (All text unchanged.)
• Prohibited Prior Therapies
• Prior treatment with Bomedemstat or other LSD1 inhibitors
• MAOIs or strong CYP3A4 modifiers
• All hematopoietic growth factors (G-CSF, GM-CSF, EPO, TPO mimetics)

Sponsors & Collaborators

• United Lincolnshire Hospitals NHS Trust: lead
• University of Lincoln: collaborator

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

bomedemstat; N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Ciro Rinaldi, MD PhD

CONTACT

00447720373877; crinaldi@nhs.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model 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.

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2029
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share