Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07424950
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. 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.
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
1. Screening Procedures
o Informed consent
o 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
2. Intervention Procedures Weeks 0-12
o Momelotinib 200 mg QD alone
o 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
3. Follow-Up Procedures o 30-day safety follow-up
o 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:
NCT07424950
Study Brief:
Protocol Section:
NCT07424950