NCT06274801招募中3 期
An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 330
- 试验地点
- 314
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study
详细描述
The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.
- •Evidence of an informed consent document, signed and dated by the subject, indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures.
- •Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- •Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at enrollment visit before first administration of Investigational Product (IP) in this study.
- •WOCBP who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of IP.
- •Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of IP.
排除标准
- •Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or seralutinib administration, unless associated with an ongoing AE and discussed with the Sponsor's medical monitor (MM) (or designee).
- •Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.
研究组 & 干预措施
Seralutinib 90 mg
Experimental
Seralutinib inhaled orally twice per day (BID)
干预措施: Seralutinib (Drug)
Seralutinib 90 mg
Experimental
Seralutinib inhaled orally twice per day (BID)
干预措施: Gereic Dry Powder Inhaler (Device)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: From baseline to end of study (up to 48 months or availability of commercial product)
次要结局
- Changes in distance achieved on the Six-Minute Walk Test (6MWT)(Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product))
- Changes in NT-proBNP(Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product))
研究者
研究点 (314)
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