Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06456346 | Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007) | PHASE3 | RECRUITING | 300 | — | — | Jul 16, 2024 | Mar 24, 2028 | Jun 8, 2026 | 171 | United States, Argentina +21 |
| NCT06079879 | A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006) | PHASE3 | RECRUITING | 340 | — | — | Dec 31, 2023 | Aug 18, 2028 | Jun 1, 2026 | 163 | United States, Argentina +22 |
| NCT04254978 | Study of Bomedemstat in Participants With Essential Thrombocythemia (IMG-7289-CTP-201/MK-3543-003) | PHASE2 | COMPLETED | 73 | — | — | Sep 8, 2020 | Mar 23, 2023 | May 4, 2026 | 26 | United States, Australia +5 |
DCHR rate is the percentage of participants with DCHR, defined as a confirmed reduction of platelet count to ≤400 × 10\^9/L, absence of white blood cell (WBC) count elevation to \>10 × 10\^9/L locally assessed to be due to ET, starting by Week 24 and maintained for at least 24 weeks, and the absence of any thrombotic or major hemorrhagic events or disease progression to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) by Week 52.
An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during the study, in conjunction with the use of the drug or biologic, whether or not product related. This includes any untoward signs or symptoms experienced by the participant from the time of first dose with study treatment until completion of the study. The number of participants who experienced an AE is reported.
An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in the study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any untoward signs or symptoms experienced by the patient from the time of first dose with study treatment until completion of the study. The number of participants who discontinued study treatment due to an AE is reported.
Blood samples were collected at pre-specified timepoints to determine platelet counts. The percentage of participants who achieved reduction in platelet count to ≤400k/μL in the absence of new thrombolytic events is reported.
| Arm | Type | Description |
|---|---|---|
| Bomedemstat | EXPERIMENTAL | Participants will receive active bomedemstat and hydroxyurea placebo daily for up to approximately 52 weeks. Dosage will be adjusted either up or down within specified time parameters for each participant to the dose that provides sufficient exposure to safely inhibit thrombopoiesis to decrease platelet counts to the target range. Participants who complete treatment at Week 52 will be eligible to continue treatment in the extended treatment phase. Unblinding will occur and placebo discontinued once all participants have completed at least 52 weeks of therapy or otherwise discontinued. |
| Hydroxyurea | ACTIVE_COMPARATOR | Participants will receive active hydroxyurea and bomedemstat placebo daily for up to 52 weeks. Dosage will be adjusted either up or down within specified time parameters for each participant to the dose that provides sufficient exposure to safely inhibit thrombopoiesis to decrease platelet counts to the target range. Participants who complete treatment at Week 52 will be eligible to continue treatment in the extended treatment phase. Unblinding will occur and placebo discontinued once all participants have completed at least 52 weeks of therapy or otherwise discontinued. |
| Best Available Therapy | ACTIVE_COMPARATOR | Each participant will receive either anagrelide, busulfan, interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b, or ruxolitinib as determined by investigator. All participants will be treated per respective approved product labels for up to 52 weeks. Participants receiving BAT for 52 weeks who stop responding to BAT are eligible to switch to bomedemstat and receive this for up to 156 weeks at the investigators discretion. |
| Name | Type | Description |
|---|---|---|
| Bomedemstat | DRUG | Oral capsule |
| Hydroxyurea | DRUG | Oral capsule |
| Bomedemstat placebo | DRUG | Oral capsule placebo |
| Hydroxyurea placebo | DRUG | Oral capsule placebo |
| Anagrelide | DRUG | Oral Capsule |
| Busulfan | DRUG | Oral Tablet |
| Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b | DRUG | Subcutaneous Solution |
| Ruxolitinib | DRUG | Oral Tablet |
Inclusion Criteria: * Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and an indication for cytoreductive therapy regardless of age or risk status * Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, a...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE3 | Bomedemstat, Hydroxyurea, Anagrelide, Busulfan, Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b |
| Incyte Corporation | INCY | 1 | PHASE1 | INCB057643, Ruxolitinib |