A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 40
- 主要终点
- Percentage of participants with one or more adverse events (AEs)
研究概览
简要总结
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 remission.
No hypothesis testing will be conducted in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 remission, 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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Bomedemstat (Drug)
结局指标
主要结局
Percentage of participants with one or more adverse events (AEs)
时间窗: 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.
Percentage of participants who discontinued study treatment due to an AE
时间窗: 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.
次要结局
- For participants with ET or PV: Duration of clinicohematologic response(Up to ~10 years)
- For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML(Up to ~10 years)
- For participants with ET or PV: Duration of hematologic remission(Up to ~10 years)
- For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML(Up to ~10 years)
- For participants with MF, ET, or PV: Percentage of participants with thrombotic events(Up to ~10 years)
- For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events(Up to ~10 years)