Last reviewed · How we verify

NCT05223920

An Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)

Completed Phase 2 Results posted Last updated 22 September 2025
What this trial tests

Phase 2 trial testing Bomedemstat in Thrombocythemia, Essential in 81 participants. Completed in 22 August 2024.

Timeline
15 December 2021
Primary endpoint
22 August 2024
22 August 2024

Quick facts

Lead sponsorImago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment81
Start date15 December 2021
Primary completion22 August 2024
Estimated completion22 August 2024
Sites19 locations across Hong Kong, Italy, New Zealand, United Kingdom, Germany, Australia, United States

Drugs / interventions tested

Conditions studied

Sponsor

Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

Who can join

18 and older, any sex, with Thrombocythemia, Essential or Primary Myelofibrosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Experience an Adverse Event (AE) Primary · Up to ~32 months

An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who experienced an AE is presented.

GroupValue95% CI
Essential Thrombocythemia (ET)98.1
Myelofibrosis (MF)100.0
Percentage of Participants Who Discontinue Study Intervention Due to an AE Primary · Up to ~32 months

An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who discontinued study intervention due to an AE is presented.

GroupValue95% CI
Essential Thrombocythemia (ET)15.4
Myelofibrosis (MF)10.3
Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF. Primary · Baseline and Days 169, 339, 509, 679, 849 and 924

Mean Spleen volume reduction (mL) in participants with MF as measured by central laboratory imaging analysis of MRI (or CT where applicable) approximately every 48 weeks. Per protocol only participants with MF were analyzed for this outcome measure. The change in spleen volume from baseline is presented.

Day 169
GroupValue95% CI
Myelofibrosis (MF)-101.570± 92.6876
Day 339
GroupValue95% CI
Myelofibrosis (MF)-67.645± 249.0079
Day 509
GroupValue95% CI
Myelofibrosis (MF)-5.920± 143.1692
Day 679
GroupValue95% CI
Myelofibrosis (MF)-61.000± 396.2520
Day 849
GroupValue95% CI
Myelofibrosis (MF)-38.840± NA
Day 924
GroupValue95% CI
Myelofibrosis (MF)80.575± 10.3308
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Primary · Baseline and Days 29, 57, 85, 113, 141, 169, 198, 226, 254, 282, 310, 338, 367, 395, 423, 451, 479, 507, 536, 564, 592, 620, and 648

Blood samples were taken at designated time points to determine platelet count. Percentage of participants with ET who achieve a reduction of platelet counts to \<= 400 K/uL (400 x 10\^9/L) in the absence of new thromboembolic events is presented.

Day 29
GroupValue95% CI
Essential Thrombocythemia (ET)77.162.7 – 88.0
Day 57
GroupValue95% CI
Essential Thrombocythemia (ET)72.958.2 – 84.7
Day 85
GroupValue95% CI
Essential Thrombocythemia (ET)72.057.5 – 83.8
Day 113
GroupValue95% CI
Essential Thrombocythemia (ET)78.464.7 – 88.7
Day 141
GroupValue95% CI
Essential Thrombocythemia (ET)91.880.4 – 97.7
Day 169
GroupValue95% CI
Essential Thrombocythemia (ET)89.476.9 – 96.5
Day 198
GroupValue95% CI
Essential Thrombocythemia (ET)86.773.2 – 94.9
Day 226
GroupValue95% CI
Essential Thrombocythemia (ET)81.867.3 – 91.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Death and adverse events up to ~32 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Essential Thrombocythemia (ET)
Serious: 19/52 (37%)
Deaths: 2/52
Myelofibrosis (MF)
Serious: 12/29 (41%)
Deaths: 0/29

Serious adverse events (51 terms)

ReactionSystemEssential Thrombocythemia …Myelofibrosis (MF)
ThrombocytopeniaBlood and lymphatic system disorders
PneumoniaInfections and infestations
Post procedural haemorrhageInjury, poisoning and procedural complications
Skin lacerationInjury, poisoning and procedural complications
Acute kidney injuryRenal and urinary disorders
Blood loss anaemiaBlood and lymphatic system disorders
Febrile neutropeniaBlood and lymphatic system disorders
Immune thrombocytopeniaBlood and lymphatic system disorders
ThrombocytosisBlood and lymphatic system disorders
Cardiac failure congestiveCardiac disorders
Supraventricular tachycardiaCardiac disorders
Wellens' syndromeCardiac disorders
Abdominal painGastrointestinal disorders
Food poisoningGastrointestinal disorders
Gingival bleedingGastrointestinal disorders
HaematemesisGastrointestinal disorders
Rectal haemorrhageGastrointestinal disorders
Upper gastrointestinal haemorrhageGastrointestinal disorders
Cholecystitis acuteHepatobiliary disorders
HypertransaminasaemiaHepatobiliary disorders
Portal vein thrombosisHepatobiliary disorders
Abscess limbInfections and infestations
Appendicitis perforatedInfections and infestations
DiverticulitisInfections and infestations
Hepatitis BInfections and infestations
Other adverse events (75 terms — click to expand)

ReactionSystemEssential Thrombocythemia …Myelofibrosis (MF)
ArthralgiaMusculoskeletal and connective tissue disorders
ThrombocytopeniaBlood and lymphatic system disorders
COVID-19Infections and infestations
AnaemiaBlood and lymphatic system disorders
DizzinessNervous system disorders
PruritusSkin and subcutaneous tissue disorders
DiarrhoeaGastrointestinal disorders
Gingival bleedingGastrointestinal disorders
FatigueGeneral disorders
Urinary tract infectionInfections and infestations
HeadacheNervous system disorders
NauseaGastrointestinal disorders
ContusionInjury, poisoning and procedural complications
Bone painMusculoskeletal and connective tissue disorders
Rectal haemorrhageGastrointestinal disorders
VomitingGastrointestinal disorders
FallInjury, poisoning and procedural complications
Back painMusculoskeletal and connective tissue disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
AlopeciaSkin and subcutaneous tissue disorders
Increased tendency to bruiseBlood and lymphatic system disorders
NeutropeniaBlood and lymphatic system disorders
PalpitationsCardiac disorders
Abdominal painGastrointestinal disorders
NasopharyngitisInfections and infestations
Upper respiratory tract infectionInfections and infestations
SARS-CoV-2 test positiveInvestigations
Decreased appetiteMetabolism and nutrition disorders
Joint swellingMusculoskeletal and connective tissue disorders
Muscle spasmsMusculoskeletal and connective tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
DysgeusiaNervous system disorders
CoughRespiratory, thoracic and mediastinal disorders
EpistaxisRespiratory, thoracic and mediastinal disorders
EcchymosisSkin and subcutaneous tissue disorders
HypertensionVascular disorders
ThrombocytosisBlood and lymphatic system disorders
VertigoEar and labyrinth disorders
Abdominal distensionGastrointestinal disorders
ConstipationGastrointestinal disorders

Most-reported serious reactions: Thrombocytopenia, Pneumonia, Post procedural haemorrhage, Skin laceration, Acute kidney injury, Blood loss anaemia, Febrile neutropenia, Immune thrombocytopenia.

Data from ClinicalTrials.gov NCT05223920 adverse events section.

Sponsor's own description

This is a multi-center, open-label extension study to assess the long-term safety and efficacy of bomedemstat administered orally once daily in participants with a Myeloproliferative Neoplasm (MPN) who participated in a prior bomedemstat study such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 (NCT03136185) and IMG-7289-CTP-201/MK-3543-003 (NCT04254978) (referred to hereafter as 'feeder studies').

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting epigenetic regulators to overcome drug resistance in cancers.
    Wang N, Ma T, Yu B, Yu B. · · 2023 · cited 213× · PMID 36797239 · DOI 10.1038/s41392-023-01341-7
  2. LSD1 inhibitors for cancer treatment: Focus on multi-target agents and compounds in clinical trials.
    Noce B, Di Bello E, Fioravanti R, Mai A. · · 2023 · cited 78× · PMID 36817147 · DOI 10.3389/fphar.2023.1120911
  3. Pharmacological targeting of the cancer epigenome.
    Mabe NW, Perry JA, Malone CF, Stegmaier K. · · 2024 · cited 36× · PMID 38937652 · DOI 10.1038/s43018-024-00777-2
  4. H3K4 trimethylation regulates cancer immunity: a promising therapeutic target in combination with immunotherapy.
    Xiao C, Fan T, Zheng Y, Tian H, et al · · 2023 · cited 21× · PMID 37553181 · DOI 10.1136/jitc-2022-005693
  5. Biological and therapeutic role of LSD1 in Alzheimer's diseases.
    Li Y, Zhao Y, Li X, Zhai L, et al · · 2022 · cited 12× · PMID 36386192 · DOI 10.3389/fphar.2022.1020556
  6. Discovery of novel dual-target inhibitors of LSD1/EGFR for non-small cell lung cancer therapy.
    Wei Y, Sun MM, Zhang RL, Wang L, et al · · 2025 · cited 7× · PMID 39753983 · DOI 10.1038/s41401-024-01439-w
  7. Unravelling the target landscape of tranylcypromines for new drug discovery.
    Song Y, Chang J, Yu B. · · 2025 · cited 1× · PMID 40654353 · DOI 10.1016/j.apsb.2025.04.012
  8. Comparative analysis for optimal LSD1 inhibitors evaluation techniques: pros and cons.
    Yin Q, Ma C, Zhao X, Wang P, et al · · 2026 · PMID 42088608 · DOI 10.1016/j.jpha.2025.101430

Verify or expand the search:

Other trials of Bomedemstat

Trials testing the same drug.

Other recruiting trials for Thrombocythemia, Essential

Currently open trials in the same condition.

Other Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA) trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05223920.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing