NCT07424950Not yet recruitingPhase 2
Bomedemstat (IMG-7289) in Combination With Momelotinib in Patients With Myelofibrosis
Phase 2 Study to Assess the Safety and Efficacy of Bomedemstat (IMG-7289) in Combination With Momelotinib in Patients With Myelofibrosis
Source: ClinicalTrials.gov · Last updated 20 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 13 Feb 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 1 Nov 2028
- Lead sponsor
- United Lincolnshire Hospitals NHS Trust
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT07424950
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 1 Nov 2026 to the primary completion date, 1 Nov 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of prohibited medications within 14 days (All text unchanged.)
- 5.2.2 Prohibited Prior Therapies
- Prior treatment with Bomedemstat or other LSD1 inhibitors
- Prior treatment with Momelotinib is allowed for Cohort 1 (required)
- Prior treatment with Momelotinib is allowed for Cohort 2 (not required)
- Prior exposure to other JAK inhibitors (e.g., ruxolitinib, fedratinib) is allowed unless associated with severe toxicity
- 5.2.3 Prohibited During Study (Verbatim text from first file retained)
- Strong inhibitors/inducers of CYP3A4
Other illness
- 5.2.1 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
- Active secondary malignancies (with exceptions)
- HBV/HCV/HIV status not meeting template criteria
Lab values
- Anticoagulants/antiplatelets/NSAIDs when platelets \<100 ×10⁹/L
Other
- Uncontrolled comorbidities
- MAOIs or strong CYP3A4 modifiers
- All hematopoietic growth factors (G-CSF, GM-CSF, EPO, TPO mimetics)
- Investigational treatments within 4 weeks
- Investigator addition permitted:
- MAOIs
Who the study is looking for
- 1\. Male or female participants ≥18 years of age on the day of signing informed consent.
- 2\. 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.