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评估 Bomedemstat 安全性和有效性的研究 (MK-3543-017)

2026年11月6日 更新者：Merck Sharp & Dohme LLC

一项多中心、开放标签、扩展研究，评估 Bomedemstat 用于治疗先前 Bomedemstat 临床研究参与者的安全性和有效性

The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria:

  • Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat;
  • Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic response.

No hypothesis testing will be conducted in this study.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

400

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 意大利
      • Alessandria、意大利、15121
        • 招聘中
        • Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2703)
        • 接触：
          • Study Coordinator
          • 电话号码：+39 0131 206440
      • Bologna、意大利、40138
        • 招聘中
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702)
        • 接触：
          • Study Coordinator
          • 电话号码：+390512143044
      • Varese、意大利、21100
        • 招聘中
        • Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701)
        • 接触：
          • Study Coordinator
          • 电话号码：+390332393906
    • Tuscany
      • Florence、Tuscany、意大利、50134
        • 招聘中
        • Azienda Ospedaliera Universitaria Careggi ( Site 2700)
        • 接触：
          • Study Coordinator
          • 电话号码：+39 0131 206440
  • 新西兰
      • Auckland、新西兰、0622
        • 主动，不招人
        • North Shore Hospital-Department of Haematology ( Site 1401)
      • Auckland、新西兰、2025
        • 主动，不招人
        • Aotearoa Clinical Trials ( Site 1400)
  • 澳大利亚
    • New South Wales
      • Camperdown、New South Wales、澳大利亚、2050
        • 招聘中
        • Royal Prince Alfred Hospital ( Site 1003)
        • 接触：
          • Study Coordinator
          • 电话号码：+61295155720
      • St Leonards、New South Wales、澳大利亚、2065
        • 招聘中
        • Royal North Shore Hospital ( Site 1001)
        • 接触：
          • Study Coordinator
          • 电话号码：+61299264383
    • Queensland
      • Buderim、Queensland、澳大利亚、4556
        • 招聘中
        • Sunshine Coast Hematology and Oncology Clinic ( Site 1006)
        • 接触：
          • Study Coordinator
          • 电话号码：+61754790000
      • Southport、Queensland、澳大利亚、4215
        • 招聘中
        • Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)
        • 接触：
          • Study Coordinator
          • 电话号码：+61756872712
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
        • 招聘中
        • Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000)
        • 接触：
          • Study Coordinator
          • 电话号码：+61870740000
    • Victoria
      • Clayton、Victoria、澳大利亚、3168
        • 招聘中
        • Monash Health ( Site 1004)
        • 接触：
          • Study Coordinator
          • 电话号码：+61395956111
  • 美国
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • 招聘中
        • University of Michigan ( Site 6000)
        • 接触：
          • Study Coordinator
          • 电话号码：734-763-4695
    • North Carolina
      • Durham、North Carolina、美国、27705
        • 招聘中
        • DUHS Duke Blood Cancer Center ( Site 6005)
        • 接触：
          • Study Coordinator
          • 电话号码：919-668-1608
    • Ohio
      • Columbus、Ohio、美国、43210
        • 招聘中
        • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)
        • 接触：
          • Study Coordinator
          • 电话号码：888-577-8839
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15232
        • 招聘中
        • UPMC Hillman Cancer Center ( Site 6004)
        • 接触：
          • Study Coordinator
          • 电话号码：412-864-6627
  • 英国
    • Hammersmith and Fulham
      • London、Hammersmith and Fulham、英国、W12 0HS
        • 招聘中
        • Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402)
        • 接触：
          • Study Coordinator
          • 电话号码：+442083834340
    • Lincolnshire
      • Boston、Lincolnshire、英国、PE21 9QS
        • 招聘中
        • Boston Pilgrim Hospital ( Site 3403)
        • 接触：
          • Study Coordinator
          • 电话号码：01205 446311
    • London, City of
      • London、London, City of、英国、NW1 2PG
        • 招聘中
        • University College London Hospital ( Site 3400)
        • 接触：
          • Study Coordinator
          • 电话号码：+442034472528
      • London、London, City of、英国、SE1 9RT
        • 招聘中
        • Guy's & St Thomas' NHS Foundation Trust ( Site 3401)
        • 接触：
          • Study Coordinator
          • 电话号码：+442071884259
  • 香港
      • Hksar、香港
        • 主动，不招人
        • Queen Mary Hospital ( Site 1601)

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck & Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready
  • Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator
  • ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic response, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator
  • Is not currently on a dose hold
  • Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat

Exclusion Criteria:

  • Has received prohibited concomitant medications
  • Ongoing or planned participation in another investigational study
  • Has noncompliance in prior bomedemstat study receiving <90% of assigned doses excluding suspensions or holds as assigned by the investigator

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Bomedemstat

Participants will receive oral capsules of bomedemstat once daily for up to 10 years, with the starting dose as the same dose that the participant was on at the time of transition from the feeder study.
药品：Bomedemstat

10, 15, 20, and 50 mg oral capsules

其他名称：
  • IMG-7289
  • MK-3543

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of participants with one or more adverse events (AEs)
大体时间：Up to ~10 years

An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in an investigational 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 bomedemstat under this protocol until completion of the study. The percentage of participants with AEs will be presented.
Up to ~10 years
Percentage of participants who discontinued study treatment due to an AE
大体时间：Up to ~10 years

An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in an investigational 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 bomedemstat under this protocol until completion of the study. The percentage of participants who discontinued study treatment due to an AE will be presented.
Up to ~10 years

次要结果测量

结果测量
措施说明
大体时间
For participants with ET: Duration of durable clinicohematologic response
大体时间：Up to ~10 years

For participants who demonstrate durable clinicohematologic response (DCHR) in their feeder study, duration of durable clinicohematologic response (DODCHR) is defined as the time from the first documented evidence of confirmed reduction of platelet and white blood cell (WBC) counts until confirmed increase of platelet and WBC counts to above acceptable threshold, thrombotic or major hemorrhagic events, or disease progression to myelofibrosis (MF), myelodysplastic syndrome (MDS), or acute myeloid leukemia (AML). DODCHR will be reported.
Up to ~10 years
For participants with ET or PV: Duration of clinicohematologic response
大体时间：Up to ~10 years

For participants who showed clinicohematologic response in their feeder study, duration of clinicohematologic response is defined as the time from the first documented evidence of confirmed reduction of platelet and WBC count until confirmed increase of platelet and WBC counts to above acceptable threshold, thrombotic or major hemorrhagic events or disease progression to MF, MDS, or AML, or phlebotomy (PV participants only). The duration of clinicohematologic response will be reported.
Up to ~10 years
For participants with ET or PV: Duration of hematologic response
大体时间：Up to ~10 years

For participants who showed confirmed hematologic response in their feeder study, duration of hematologic response is defined as the time from the first documented evidence of confirmed reduction of platelet and WBC count until confirmed increase of platelet and WBC counts to above acceptable threshold, or phlebotomy (PV participants only). The duration of hematologic response will be reported.
Up to ~10 years
For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML
大体时间：Up to ~10 years

Disease Progression is defined as the transformation to post-ET myelofibrosis (ET participants only), post-PV myelofibrosis (PV participants only), spleen volume increase ≥25% (MF participants only), myelodysplastic syndrome, or acute myeloid leukemia as assessed by the investigator. The percentage of participants with transformation to MF or MDS/AML will be reported.
Up to ~10 years
For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML
大体时间：Up to ~10 years

Spleen volume will be assessed by magnetic resonance imaging (MRI) (or computed tomography [CT] where applicable) at pre-specified timepoints. The percentage of participants with worsening of splenomegaly or transformation to MDS/AML will be reported.
Up to ~10 years
For participants with MF, ET, or PV: Percentage of participants with thrombotic events
大体时间：Up to ~10 years

Thrombotic events are defined as: new or recurrent acute myocardial infarction; unstable angina; stroke; transient ischemic attack (TIA); deep venous thrombosis (DVT); pulmonary embolism (PE); thrombotic digital ischemia; other thrombotic events such as peripheral limb ischemia or Budd-Chiari syndrome that are assessed to be due to underlying PV; other vascular occlusive events such as symptoms of cardiac, abdominal or peripheral limb ischemia supported by objective evidence of vessel disease and/or ischemia. The percentage of participants with thrombotic events will be presented.
Up to ~10 years
For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events
大体时间：Up to ~10 years

Hemorrhagic events are defined as: Major Bleeding (MB) Events such as fatal bleeding, and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 2 g/dL or more, or leading to transfusion of 2 or more units of whole blood or red cells; Clinically Relevant Non-Major Bleeding (CRNMB) Events Leading to hospitalization or increased level of care or clinically important, prompting a face-to-face medical evaluation. The percentage of participants with major hemorrhagic events will be presented.
Up to ~10 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Merck Sharp & Dohme LLC

调查人员

  • 研究主任：Medical Director、Merck Sharp and Dohme LLC

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年5月23日

初级完成 (估计的)

2034年12月4日

研究完成 (估计的)

2034年12月4日

研究注册日期

首次提交

2024年4月2日

首先提交符合 QC 标准的

2024年4月2日

首次发布 (实际的)

2024年4月8日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月6日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 3543-017
  • U1111-1294-8621 (注册表标识符：UTN)
  • MK-3543-017 (其他标识符：MSD)
  • 2023-506996-89-00 (注册表标识符：EU CT)
  • 2023 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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