A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (INCB039110)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 38
- 主要终点
- Treatment Emergent Adverse Events (TEAE's)
研究概览
简要总结
This is a mutli-center open-label study to provide continued supply of itacitinib to participants from the following Incyte-sponsored studies of itacitinib: INCB39110-209, INCB39110-213, INCB39110-214, INCB39110-230, and 39110-309. Eligible participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. The original study is referred to as the "parent protocol".
Participants who receive itacitinib in this study may continue treatment as long as the regimen is tolerated, the participant is deriving clinical benefit (in the opinion of the investigator), and the participant does not meet discontinuation criteria.
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
盲法说明
Open Label
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
- •Currently enrolled and receiving treatment in an Incyte-sponsored itacitinib (INCB39110)-based clinical study (parent Protocol).
- •Currently tolerating treatment as defined by the parent Protocol.
- •Currently receiving clinical benefit from itacitinib-based treatment, as determined by the investigator.
- •Has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.
- •Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this Protocol.
- •Willingness to avoid pregnancy or fathering children..
- •Ability to comprehend and willingness to sign an ICF.
排除标准
- •Able to access itacitinib therapy commercially.
- •Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
itacitinib
Participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. Participants who are receiving ruxolitinib under parent protocol INCB39110-209 may continue to receive it as described in that protocol.
干预措施: itacitinib (Drug)
结局指标
主要结局
Treatment Emergent Adverse Events (TEAE's)
时间窗: 3 years
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
次要结局
未报告次要终点