Trial · NCT05223920
An Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)
NCT05223920, Phase 2, Completed, Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA); results first posted 2025-09-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005). Trials, record NCT05223920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05223920
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)
- NCT number
- NCT05223920
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 81 participants, actual
- Lead sponsor
- Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
- Conditions
- Thrombocythemia, Essential, Primary Myelofibrosis
- Interventions
- Bomedemstat
- First posted
- 2022-02-04
- Last updated
- 2025-09-22
- Other registries' IDs
- eudract:2021-002452-37
- Results first posted
- 2025-09-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Experience an Adverse Event (AE) | 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. |
| Primary | Percentage of Participants Who Discontinue Study Intervention Due to an AE | 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. |
| Primary | Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF. | 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. |
| Primary | 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 | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Experience an Adverse Event (AE) | Up to ~32 months | All participants who received at least one dose of study intervention | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinue Study Intervention Due to an AE | Up to ~32 months | All participants who received at least one dose of study intervention | Percentage of Participants | NUMBER |
| PRIMARY | Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF. | Baseline and Days 169, 339, 509, 679, 849 and 924 | The modified intent to treat (mITT) population included all participants who were enrolled in the study, received at least 1 dose of study intervention, and who had a nonmissing baseline and at least 1 nonmissing postbaseline efficacy assessment. Participants were analyzed according to treatment received in the study. Per protocol only participants with MF were analyzed for this outcome measure. | mL | MEAN |
| PRIMARY | 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 | 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 | The modified intent to treat (mITT) population included all participants who were enrolled in the study, received at least 1 dose of study intervention, and who had a nonmissing baseline and at least 1 nonmissing postbaseline efficacy assessment. Per protocol only participants with ET were analyzed for this outcome measure. Participants were analyzed according to treatment received in the study. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Experience an Adverse Event (AE) | Essential Thrombocythemia (ET) | 98.1 | Percentage of Participants | ||
| Percentage of Participants Who Experience an Adverse Event (AE) | Myelofibrosis (MF) | 100.0 | Percentage of Participants | ||
| Percentage of Participants Who Discontinue Study Intervention Due to an AE | Essential Thrombocythemia (ET) | 15.4 | Percentage of Participants | ||
| Percentage of Participants Who Discontinue Study Intervention Due to an AE | Myelofibrosis (MF) | 10.3 | Percentage of Participants | ||
| Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF. | Myelofibrosis (MF) | Day 169 | -101.570 | Standard Deviation 92.6876 | mL |
| Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF. | Myelofibrosis (MF) | Day 339 | -67.645 | Standard Deviation 249.0079 | mL |
| Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF. | Myelofibrosis (MF) | Day 509 | -5.920 | Standard Deviation 143.1692 | mL |
| Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF. | Myelofibrosis (MF) | Day 679 | -61.000 | Standard Deviation 396.2520 | mL |
| Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF. | Myelofibrosis (MF) | Day 849 | -38.840 | Standard Deviation NA | mL |
| Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF. | Myelofibrosis (MF) | Day 924 | 80.575 | Standard Deviation 10.3308 | mL |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Essential Thrombocythemia (ET) | 52 | |
| Overall Study | STARTED | Myelofibrosis (MF) | 29 | |
| Overall Study | COMPLETED | Essential Thrombocythemia (ET) | 0 | |
| Overall Study | COMPLETED | Myelofibrosis (MF) | 0 | |
| Overall Study | NOT COMPLETED | Essential Thrombocythemia (ET) | 52 | |
| Overall Study | NOT COMPLETED | Myelofibrosis (MF) | 29 |
Source ClinicalTrials.gov
Adverse events252
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Essential Thrombocythemia (ET) | 10 | 52 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Myelofibrosis (MF) | 7 | 29 | 16 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Essential Thrombocythemia (ET) | 2 | 52 | 2 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Myelofibrosis (MF) | 4 | 29 | 4 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Essential Thrombocythemia (ET) | 0 | 52 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Myelofibrosis (MF) | 2 | 29 | 4 |
| other | Neutropenia | Blood and lymphatic system disorders | Essential Thrombocythemia (ET) | 4 | 52 | 5 |
| other | Neutropenia | Blood and lymphatic system disorders | Myelofibrosis (MF) | 2 | 29 | 2 |
| other | Polycythaemia | Blood and lymphatic system disorders | Essential Thrombocythemia (ET) | 0 | 52 | 0 |
| other | Polycythaemia | Blood and lymphatic system disorders | Myelofibrosis (MF) | 2 | 29 | 4 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Essential Thrombocythemia (ET) | 2 | 52 |
| Total, all-cause mortality | Myelofibrosis (MF) | 0 | 29 |
| Total, other adverse events | Essential Thrombocythemia (ET) | 45 | 52 |
| Total, other adverse events | Myelofibrosis (MF) | 28 | 29 |
| Total, serious adverse events | Essential Thrombocythemia (ET) | 19 | 52 |
| Total, serious adverse events | Myelofibrosis (MF) | 12 | 29 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Essential Thrombocythemia (ET) vs Myelofibrosis (MF): deaths from any cause | Trial comparisons |
| Essential Thrombocythemia (ET) vs Myelofibrosis (MF): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05223920
GET https://conductscience.org/api/trials/v1/NCT05223920/results?page=2