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NCT07424950

PHASE2

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

Sponsor: United Lincolnshire Hospitals NHS Trust

View on ClinicalTrials.gov

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.

Official title: Phase 2 Study to Assess the Safety and Efficacy of Bomedemstat (IMG-7289) in Combination With Momelotinib in Patients With Myelofibrosis

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-11-01

Completion Date

2029-11-01

Last Updated

2026-02-20

Healthy Volunteers

Conditions

Myelofibrosis

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)

Inclusion Criteria: * 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 Exclusion Criteria: 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 * 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.) 5.2.2 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) * Investigational treatments within 4 weeks Investigator addition permitted: * 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) * MAOIs * Strong inhibitors/inducers of CYP3A4 * Anticoagulants/antiplatelets/NSAIDs when platelets \<100 ×10⁹/L