A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

Hoffmann-La Roche937 个研究点分布在 1 个国家目标入组 2,000 人2023年6月28日

适应症Chronic Obstructive Pulmonary Disease

干预措施Astegolimab

概览

阶段: 3 期
干预措施: Astegolimab
疾病 / 适应症: Chronic Obstructive Pulmonary Disease
发起方: Hoffmann-La Roche
入组人数: 2000
试验地点: 937
主要终点: Incidence of all adverse events (AEs)
状态: 招募中
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2023年6月28日

结束日期

2027年6月30日

最后更新

2个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Hoffmann-La Roche

责任方

Sponsor

入排标准

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

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