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Not recruiting
Phase 3

Bomedemstat vs. Hydroxyurea

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06456346

Conditions

Essential Thrombocythemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bomedemstat

Hydroxyurea

Bomedemstat placebo

Hydroxyurea placebo

Study Details

Brief summary:

The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR.

Conditions

Essential Thrombocythemia

Study ID

NCT06456346

Start date

Jul 16, 2024

Status verified date

Jul, 2026

Completion date

Mar 24, 2028

Anticipated

Primary completion date

Sep 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis
  • Has received no prior cytoreductive treatment for their ET
  • Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy
  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
  • Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

  • History of any illness/impairment of gastrointestinal function that might interfere with drug absorption
  • History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has an active infection requiring systemic therapy
  • Has had a major surgery <4 weeks prior to first dose of study intervention or has not recovered from side effects of major surgery >4 weeks prior to first dose

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bomedemstat

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.

active comparator: Hydroxyurea

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.

Interventions

Bomedemstat

Oral capsule

Hydroxyurea

Oral capsule

Bomedemstat placebo

Oral capsule placebo

Hydroxyurea placebo

Oral capsule placebo

Primary outcome measure

  • Durable Clinicohematologic Response (DCHR) Rate [ Time Frame: Up to Week 52 ]

Central Contacts and Locations

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

  • essential thrombocythemia
  • ET
  • bomedemstat
  • IMG-7289

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-07-17.