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Bomedemstat 治疗真性红细胞增多症患者

2026年4月16日 更新者：Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

一项 2 期多中心、开放标签研究，以评估 Bomedemstat 在真性红细胞增多症 (PV) 患者中的安全性、有效性、药代动力学和药效学

这是一项针对真性红细胞增多症患者的口服 LSD1 抑制剂博美司他 (IMG-7289) 的 2 期开放标签研究。

本研究调查以下内容：

  • 博美司他的安全性和耐受性
  • 博美司他的药效学作用

研究概览

地位

完全的

条件

干预/治疗

详细说明

这是一项 2 期多中心、开放标签研究，评估每天一次口服博美司他治疗真性红细胞增多症患者的安全性、有效性、药代动力学和药效学。

患者将接受 36 周的给药，此后可能有资格接受额外治疗。

通过频繁监测临床体征和症状以及安全实验室，将在整个研究过程中密切关注患者的不良事件。 将通过频繁的外周血血液学评估密切监测疗效和药效学效应。 在整个给药过程中，如果需要，可以根据标准机构指南进行输血或静脉切开术。

为确保安全，安全咨询委员会将定期审查安全参数和药效学指标。

研究类型

介入性

注册 (实际的)

20

阶段

  • 阶段2

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。

学习地点

  • 澳大利亚
    • Queensland
      • Sunshine Coast、Queensland、澳大利亚、4556
        • Sunshine Coast Hematology and Oncology Clinic (Site 0506)
    • Victoria
      • Clayton、Victoria、澳大利亚、3168
        • Monash Medical Centre ( Site 0006)
    • Western Australia
      • Perth、Western Australia、澳大利亚、6000
        • Royal Perth Hospital ( Site 0504)
  • 美国
    • Florida
      • Plantation、Florida、美国、33322
        • BRCR Global ( Site 0120)
    • Illinois
      • Skokie、Illinois、美国、60076-1264
        • Hematology Oncology of the North Shore ( Site 0104)
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • University of Michigan Comprehensive Cancer Center ( Site 0008)
    • Nevada
      • Las Vegas、Nevada、美国、89128
        • Comprehensive Cancer Centers of Nevada - Peak ( Site 0118)
    • North Carolina
      • Durham、North Carolina、美国、27705
        • Duke University Medical Center ( Site 0016)
    • Ohio
      • Columbus、Ohio、美国、43203
        • Ohio State University Comprehensive Cancer Center ( Site 0103)
    • Oregon
      • Portland、Oregon、美国、97239-4503
        • OHSU Knight Cardiovascular Institute Cardiology Clinic - South Waterfront ( Site 0102)
    • Utah
      • Salt Lake City、Utah、美国、84112
        • Huntsman Cancer Hospital at the University of Utah ( Site 0119)
  • 英国
    • England
      • Gloucester、England、英国、GL1 3NN
        • Gloucestershire Royal Hospital ( Site 0205)
    • Great Britain
      • Lincoln、Great Britain、英国、LN2 5QY
        • United Lincolnshire Hospitals NHS Trust ( Site 0204)
      • London、Great Britain、英国、W12 0HS
        • Imperial College London ( Site 0025)
    • Lincolnshire
      • Boston、Lincolnshire、英国、PE21 9QS
        • Boston Pilgrim Hospital ( Site 0207)
    • London, City of
      • London、London, City of、英国、SE1 9RT
        • Guys and St Thomas NHS Foundation Trust - Guys Hospital ( Site 0020)
    • Wales
      • Newport、Wales、英国、NP9 2UB
        • Royal Gwent Hospital ( Site 0201)

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

描述

纳入标准：

  • 根据世界卫生组织 (WHO) 骨髓增生性肿瘤诊断标准诊断真性红细胞增多症
  • 0 级或 1 级的骨髓纤维化评分
  • 至少一种标准细胞减灭疗法未能降低血细胞比容的患者
  • 血小板计数 ≥250 x 10^9/L
  • 中性粒细胞绝对计数 (ANC) ≥1.5 x 10^9/L
  • 预期寿命 >36 周。
  • 必须在研究药物开始前停止先前的细胞减灭治疗 2 周（干扰素 4 周）。

排除标准：

  • 东部肿瘤合作组 (ECOG) 表现状态 3 分或更高
  • 先前治疗中未解决的治疗相关毒性（除非解决至≤ 1 级）。
  • 不受控制的活动性感染。
  • 目前使用违禁药物
  • 已知的 HIV 感染或活动性乙型或丙型肝炎病毒感染
  • 出血风险增加的证据，包括已知的出血性疾病
  • 根据方案，其他血液学/生物化学要求
  • 怀孕或哺乳期女性

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：波梅登司他
参与者将在 36 周内每天接受 bomedemstat 治疗，如果获得临床益处，则可能有资格在第 52 周之前接受额外治疗。
药品：波梅登司他
口服胶囊
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
Number of Participants With Adverse Events (AEs)
大体时间：Up to approximately 52 weeks
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with one or more AEs are reported.
Up to approximately 52 weeks
Number of Participants Who Discontinued Study Intervention Due to AEs
大体时间：Up to approximately 52 weeks
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study intervention due to an AE are reported.
Up to approximately 52 weeks
Percentage of Participants With Sustained 12-week Reduction of Hematocrit (Hct) to <45% Without Concomitant Phlebotomy by Week 36
大体时间：Up to approximately 36 weeks
Hematocrit (Hct) was analyzed by taking blood samples from participants at designated time points during the study. Participants were considered responders if they achieved a sustained reduction of Hct to <45% for 12 weeks (84 calendar days) by Week 36 AND there was no concomitant phlebotomy performed during the sustained reduction. Baseline data was defined as the data most recently collected prior to the first dose. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders was presented. The percentage of participants who achieved a sustained 12-week reduction of Hct to <45% without concomitant phlebotomy at Week 36 are reported.
Up to approximately 36 weeks

次要结果测量

结果测量
措施说明
大体时间
Duration of Reduction of Hematocrit (Hct) to <45% Without Phlebotomy
大体时间：Up to approximately 22 months
Total response duration was defined as the summation of all Hct <45% response durations, where an individual response duration starts at the timepoint where the Hct <45% and ends at the first subsequent occurrence of phlebotomy or Hct >=45%. Hct was analyzed by taking blood samples from participants at designated time points during the study. Duration of reduction of Hct to <45% without phlebotomy was presented.
Up to approximately 22 months
Percentage of Participants With Platelet Count ≤ 450 x 10^9/L by Week 36
大体时间：Up to approximately 36 weeks
Platelet count was analyzed by taking blood samples from participants at designated time points during the study. Participants who enter the study with platelet counts ≤450 X 10^9/L must achieve an additional on-study platelet count ≤450 X 10^9/L to be considered responders. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders is presented. Baseline data was defined as the data most recently collected prior to the first dose. The percentage of participants who have a platelet count ≤450 X 10^9/L by week 36 are reported.
Up to approximately 36 weeks
Duration of Platelet Count ≤ 450 x 10^9/L
大体时间：Up to approximately 22 months
Total response duration was defined as the summation of all platelet ≤450 x 10^9/L response durations, where an individual response duration starts at the timepoint where platelet count ≤450 x 10^9/L and ends at the first subsequent occurrence of platelet >450 x 10^9/L. Platelet counts were analyzed by taking blood samples from participants at designated time points during the study. The duration of platelet count ≤450 X 10^9/L in participants are reported.
Up to approximately 22 months
Percentage of Participants With White Blood Cell (WBC) Count <10 x 10^9/L by Week 36
大体时间：Up to approximately 36 weeks
WBC count was analyzed by taking blood samples from participants at designated time points during the study. Participants who enter the study with WBC counts <10 X 10^9/L must achieve an additional on-study WBC count <10 X 10^9/L to be considered responders. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders is presented. Baseline data was defined as the data most recently collected prior to the first dose. The percentage of participants who have a WBC count <10 X 10^9/L week 36 are reported.
Up to approximately 36 weeks
Duration of White Blood Cell (WBC) Count <10 x 10^9/L
大体时间：Up to approximately 22 months
Total response duration was defined as the summation of all WBC <10 x 10^9/L response durations, where an individual response duration starts at the timepoint when WBC <10 x 10^9/L and ends at the first subsequent occurrence of WBC ≥ 10 x 10^9/L. WBC count was analyzed by taking blood samples from participants at designated time points during the study. The duration of WBC count <10 X 10^9/L in participants are reported.
Up to approximately 22 months
Number of Participants With Thrombotic Events
大体时间：Up to approximately 22 months
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 polycythemia vera (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. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with thrombotic events are reported.
Up to approximately 22 months
Number of Participants With Major Hemorrhagic Events
大体时间：Up to approximately 22 months
Hemorrhagic events were 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. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with major hemorrhagic events are reported.
Up to approximately 22 months
Number of Participants With an Enlarged Spleen at Baseline Who Had a Reduction in Splenic Volume by 36 Weeks
大体时间：Up to approximately 36 weeks
Spleen volume was measured by magnetic resonance imaging (MRI) (or computerized tomography [CT] if participant is not a candidate for MRI) of the abdomen according to standard procedures. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with an enlarged spleen at baseline (volume >450 cm^3) who achieved any reduction in spleen volume by Week 36 are reported.
Up to approximately 36 weeks
Number of Participants With Progressive Disease (PD)
大体时间：Up to approximately 52 weeks
PD was defined as the worsening of Polycythemia Vera (PV) to post-PV myelofibrosis, myelodysplastic syndrome or transformation to acute myeloid leukemia. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with PD are reported.
Up to approximately 52 weeks

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

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

调查人员

  • 研究主任：Medical Director、Merck Sharp & 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)

2023年9月7日

初级完成 (实际的)

2025年3月24日

研究完成 (实际的)

2025年7月10日

研究注册日期

首次提交

2022年9月20日

首先提交符合 QC 标准的

2022年9月26日

首次发布 (实际的)

2022年9月28日

研究记录更新

最后更新发布 (实际的)

2026年5月7日

上次提交的符合 QC 标准的更新

2026年4月16日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 3543-004
  • IMG-7289-CTP-203 (其他标识符：Imagobio ID)
  • MK-3543-004 (其他标识符：MSD)
  • 2022-002262-32 (EudraCT编号)

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

http://engagezone.msd.com/doc/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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