Phase 2
N=20
A Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Polycythemia Vera (IMG-7289-CTP-203/MK-3543-004)
Polycythemia Vera
Bottom Line
View on ClinicalTrials.gov: NCT05558696 ↗Enrolled (actual)
20
Serious AEs
40.0%
Results posted
May 2026
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) — 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bomedemstat (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
20 | — |
| PRIMARY Number of Participants Who Discontinued Study Intervention Due to AEs |
— | — |
| PRIMARY Percentage of Participants With Sustained 12-week Reduction of Hematocrit (Hct) to <45% Without Concomitant Phlebotomy by Week 36 |
45.0 | — |
| SECONDARY Duration of Reduction of Hematocrit (Hct) to <45% Without Phlebotomy |
6.4 | — |
| SECONDARY Percentage of Participants With Platelet Count ≤ 450 x 10^9/L by Week 36 |
90.0 | — |
| SECONDARY Duration of Platelet Count ≤ 450 x 10^9/L |
11.3 | — |
| SECONDARY Percentage of Participants With White Blood Cell (WBC) Count <10 x 10^9/L by Week 36 |
75.0 | — |
| SECONDARY Duration of White Blood Cell (WBC) Count <10 x 10^9/L |
6.5 | — |
| SECONDARY Number of Participants With Thrombotic Events |
— | — |
| SECONDARY Number of Participants With Major Hemorrhagic Events |
1 | — |
| SECONDARY Number of Participants With an Enlarged Spleen at Baseline Who Had a Reduction in Splenic Volume by 36 Weeks |
6 | — |
| SECONDARY Number of Participants With Progressive Disease (PD) |
1 | — |
Summary
This study will evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics of the orally administered lysine-specific demethylase 1 (LSD1) inhibitor bomedemstat, in participants with polycythemia vera (PV). At Week 36 of dosing, participants will be assessed for eligibility to receive additional treatment through Week 52. Participants deriving clinical benefit and safely tolerating bomedemstat will qualify for continued treatment at the Investigator's discretion.
Eligibility Criteria
Inclusion Criteria
- Has a diagnosis of Polycythemia Vera per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms
- Has a bone marrow fibrosis score of Grade 0 or Grade 1
- Has failed at least one standard cytoreductive therapy to lower hematocrit
- Has a life expectancy >36 weeks
- Has discontinued prior cytoreductive therapy for 2 weeks (4 weeks for interferon) prior to study drug initiation
Exclusion Criteria
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater
- Has unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1)
- Has an uncontrolled active infection
- Has a known human immunodeficiency virus (HIV) infection or active Hepatitis A, Hepatitis B or Hepatitis C virus infection
- Has evidence of increased risk of bleeding, including known bleeding disorders
- Is pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT05558696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.