MyelofibrosisPhase 2NCT07424950
Bomedemstat (IMG-7289) in Combination With Momelotinib in Patients With Myelofibrosis
A Phase 2 study testing bomedemstat in people with Myelofibrosis, run by United Lincolnshire Hospitals NHS Trust.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- bomedemstat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase 2 Study to Assess the Safety and Efficacy of Bomedemstat (IMG-7289) in Combination With Momelotinib in Patients With Myelofibrosis
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:
- Screening Phase (up to 28 days)
- Momelotinib Monotherapy Phase - Weeks 0-12
- Combination Treatment Phase (Momelotinib + Bomedemstat) - Weeks 12-24
- 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.
Read the detailed description
Myelofibrosis is a disease with heterogeneous driver pathways involving JAK-STAT activation, inflammatory cytokine signaling, and aberrant megakaryopoiesis. Momelotinib targets JAK1/JAK2 and ACVR1, improving anemia and splenomegaly. However, a proportion of patients fail to achieve adequate spleen, symptom, or hematologic improvement.
Bomedemstat, an irreversible LSD1 inhibitor, may:
- Modify megakaryocyte function
- Reduce fibrosis
- Improve cytokine dysregulation
- Impact stem/progenitor dynamics Sequential introduction of Bomedemstat at Week 12 allows assessment of Momelotinib's initial stabilizing effect and evaluates whether LSD1 inhibition can rescue suboptimal responders without compromising hematologic tolerability.
STUDY DURATION
- Screening: Up to 28 days
- Momelotinib monotherapy: Weeks 0-12
- Bomedemstat + Momelotinib combination: Weeks 12-24
- Primary endpoint assessment: Week 24
- Safety follow-up: 30 days post last dose
- Long-term follow-up: Every 12 weeks for up to 12 months Total participation duration per patient: Approximately 14-16 months
NUMBER OF PARTICIPANTS Approximately 40 participants will be enrolled across multiple international sites. This sample size provides adequate precision for estimation of the primary endpoint (SVR35) and is consistent with exploratory Phase 2 combination studies.
INVESTIGATIONAL PLAN OVERVIEW
- Screening Procedures
- Informed consent
- Medical history, physical exam
- Hematology, chemistry, thyroid function
- Bone marrow biopsy (if unavailable within 6 months)
- Spleen volume imaging (MRI or CT)
- MPN-SAF Total Symptom Score
- ECG, urinalysis
- Eligibility confirmation
- Intervention Procedures Weeks 0-12
- Momelotinib 200 mg QD alone
- Hematologic monitoring
- Week 12 response assessment Weeks 12-24
- Bomedemstat 50 mg QD added
- Titration per MF-specific rules (standard tables retained verbatim)
- Weekly CBCs during first 4 weeks of combination
- MRI/CT at Week 24
- Follow-Up Procedures o 30-day safety follow-up
- Every 12-week long-term survival and disease progression follow-up STUDY SCHEMA (REQUIRED BY THE FIRST FILE) 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)
- Conditions
- Myelofibrosis
- Being tested
- bomedemstat
- Keywords
- myelofibrosis, bomedestat, momelotinib
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bomedemstatDrug
Also called Momelotinib
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 group | Role | What they receive |
|---|---|---|
| Bomedemstat + Momelotinib | Experimental | Bomedemstat + Momelotinib Receives: Drug: bomedemstat |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR35 at Week 24
spleen value reduction by 35%
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Lincolnshire Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lincoln
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424950
- Sponsor's protocol ID
- 49027
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study to Assess the Safety and Efficacy of Bomedemstat (IMG-7289) in Combination With Momelotinib in Patients With Myelofibrosis
- ClinicalTrials.gov ID
- NCT07424950
- Acronym / sponsor ID
- 49027
- Conditions
- Myelofibrosis
- Keywords
- myelofibrosis, bomedestat, momelotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- United Lincolnshire Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Lincoln
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Screening Phase (up to 28 days)
- Momelotinib Monotherapy Phase - Weeks 0-12
- Combination Treatment Phase (Momelotinib + Bomedemstat) - Weeks 12-24
- 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.
Detailed description
Myelofibrosis is a disease with heterogeneous driver pathways involving JAK-STAT activation, inflammatory cytokine signaling, and aberrant megakaryopoiesis. Momelotinib targets JAK1/JAK2 and ACVR1, improving anemia and splenomegaly. However, a proportion of patients fail to achieve adequate spleen, symptom, or hematologic improvement.
Bomedemstat, an irreversible LSD1 inhibitor, may:
- Modify megakaryocyte function
- Reduce fibrosis
- Improve cytokine dysregulation
- Impact stem/progenitor dynamics Sequential introduction of Bomedemstat at Week 12 allows assessment of Momelotinib's initial stabilizing effect and evaluates whether LSD1 inhibition can rescue suboptimal responders without compromising hematologic tolerability.
STUDY DURATION
- Screening: Up to 28 days
- Momelotinib monotherapy: Weeks 0-12
- Bomedemstat + Momelotinib combination: Weeks 12-24
- Primary endpoint assessment: Week 24
- Safety follow-up: 30 days post last dose
- Long-term follow-up: Every 12 weeks for up to 12 months Total participation duration per patient: Approximately 14-16 months
NUMBER OF PARTICIPANTS Approximately 40 participants will be enrolled across multiple international sites. This sample size provides adequate precision for estimation of the primary endpoint (SVR35) and is consistent with exploratory Phase 2 combination studies.
INVESTIGATIONAL PLAN OVERVIEW
- Screening Procedures
- Informed consent
- Medical history, physical exam
- Hematology, chemistry, thyroid function
- Bone marrow biopsy (if unavailable within 6 months)
- Spleen volume imaging (MRI or CT)
- MPN-SAF Total Symptom Score
- ECG, urinalysis
- Eligibility confirmation
- Intervention Procedures Weeks 0-12
- Momelotinib 200 mg QD alone
- Hematologic monitoring
- Week 12 response assessment Weeks 12-24
- Bomedemstat 50 mg QD added
- Titration per MF-specific rules (standard tables retained verbatim)
- Weekly CBCs during first 4 weeks of combination
- MRI/CT at Week 24
- Follow-Up Procedures o 30-day safety follow-up
- Every 12-week long-term survival and disease progression follow-up STUDY SCHEMA (REQUIRED BY THE FIRST FILE) 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bomedemstat + Momelotinib | Experimental | Drug: bomedemstatBomedemstat + Momelotinib |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1. Male or female participants ≥18 years of age on the day of signing informed consent.
- Receiving Momelotinib 200 mg QD for ≥12 weeks prior to Week 12 assessment
- Demonstrates suboptimal response at Week 12 (definition below)
- Baseline Hb <10 g/dL and/or platelets <100 × 10⁹/L
- Starting Momelotinib at Week 0
Key exclusion criteria (24 listed)
- 5.2.1 Medical Conditions
- Known hypersensitivity to Bomedemstat or MAOIs
- Clinically significant GI conditions affecting absorption
- Increased bleeding risk
- Hereditary bleeding disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bomedemstatAlso: MomelotinibScreening (≤ 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) | Drug | Bomedemstat + Momelotinib |
Primary outcome
SVR35 at Week 24
Time frame: 24 weeks
spleen value reduction by 35%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bomedemstat in people with Myelofibrosis, run by United Lincolnshire Hospitals NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ciro Rinaldi, MD PhD (00447720373877, crinaldi@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR35 at Week 24 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.