An Open-label, Multi-center, Long-term Extension Study to Evaluate the Long-term Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 2,380
- 试验地点
- 275
- 主要终点
- Number of Participants With AEs leading to Discontinuation
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and tolerability of Admilparant in participants who completed participation in parent studies IM027-068 (for idiopathic pulmonary fibrosis (IPF)) and IM027-1015 (for progressive pulmonary fibrosis (PPF)).
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Participants must have participated in either IM027068 or IM0271015 without discontinuing treatment permanently due to withdrawal of informed consent in either IM027068 or IM0271015.
排除标准
- •Any disease/condition that, in the investigator's judgment, may pose an unacceptable safety risk for study participation.
- •Any AE that resulted in permanent discontinuation of IMP in IM027068 or IM
- •Exhibit symptoms of heart failure at rest.
- •History of lung reduction surgery or lung transplant.
- •Participants with known PAH (Pulmonary Arterial Hypertension) who has been on single-drug therapy that now requires multi-drug therapy.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
BMS-986278 Arm
干预措施: BMS-986278 (Drug)
结局指标
主要结局
Number of Participants With AEs leading to Discontinuation
时间窗: Up to Week 100
Number of Participants With AEs leading to Deaths
时间窗: Up to Week 100
Number of Participants With Clinically Significant Laboraty Abnormalities
时间窗: Up to Week 100
Number of Participants With Clinically Significant Electocardiogram (ECG) Abnormalities
时间窗: Up to Week 100
Number of Participants With Clinically Significant Vital Sign Abnormalities
时间窗: Up to Week 100
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to Week 100
Number of Participants With Serious Adverse Events (SAEs)
时间窗: Up to Week 100
次要结局
未报告次要终点