NCT05878769进行中（未招募）3 期
A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
- 试验地点
- 1,363
- 主要终点
- Incidence of all adverse events (AEs)
研究概览
简要总结
The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.
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
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the 52-week treatment period in either parent GB43311 or GB44332
排除标准
- •Withdrawal of consent and/or premature discontinuation from parent study
- •Any permanent discontinuation of study drug in parent study
- •Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment
- •Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study
- •Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study
- •Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study
研究组 & 干预措施
Open-Label Extension
Experimental
Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study
干预措施: Astegolimab (Drug)
结局指标
主要结局
Incidence of all adverse events (AEs)
时间窗: Up to 12 weeks after last dose of study treatment
次要结局
未报告次要终点
研究者
研究点 (1363)
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