NCT07677059招募中2 期
A Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Safety and Tolerability of KT-621 in Participants With Asthma Previously Enrolled in a KT-621 Asthma Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This Phase 2b open-label, long-term extension study is designed to evaluate the long-term safety and efficacy of KT-621 in participants with asthma who were previously enrolled in the parent study (KT621-AS-202) of KT-621 for asthma. The main goals of this study are to investigate the long-term safety and tolerability of KT-621, the long-term efficacy of KT-621 at treating asthma, and how KT-621 behaves in the body long-term.
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
- •Must have completed all visits of the parent study, per its protocol, up to the end of treatment (EoT) visit.
- •Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, other study-related procedures, and questionnaires, including completing the electronic diary (e-diary), for the duration of the study as required by the study protocol.
- •Must agree to contraceptive requirements in compliance with the clinical study and local requirements.
排除标准
- •Must not have experienced any clinically significant change in health status during the parent study, which, in the opinion of the Investigator, would interfere with participant safety, study evaluations, or compliance with study procedures; or otherwise make the participant unsuitable for participation in this study.
- •Must not have developed an AE during the parent study, that in the opinion of the Investigator or of the Sponsor's Medical Monitor, could indicate that continued treatment may present an unreasonable risk for the participant.
- •Must not have met permanent discontinuation criteria and/or permanently discontinued study treatment for any reason during the parent study.
- •Must not be a member of the Sponsor or site's investigational team or their immediate family.
- •Must not be unsuitable to enter the study for any other reason, as judged by the Investigator, including potential risk of noncompliance to study procedures.
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: From baseline through Week 52
Incidence of treatment-emergent serious adverse events (SAEs)
时间窗: From baseline through Week 52
次要结局
- Change from baseline in Asthma Control Questionnaire 5-question version (ACQ-5) score(From baseline (as assessed in the parent study) to Week 52)
- Change from baseline in Standardized Asthma Quality of Life Questionnaire [AQLQ(S)] global Score(From baseline (as assessed in the parent study) to Week 52)
- Plasma concentration of KT-621 derived from plasma concentration time data(From baseline to Week 52)
- Change from baseline in post-bronchodilator FEV1(From baseline (as assessed in the parent study) to Week 52)
- Change from baseline in pre-bronchodilator FEV1(From baseline (as assessed in the parent study) to Week 52)
研究者
研究点 (1)
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