Status:
RECRUITING
A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-90 years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Completion of the 52-week treatment period in either parent GB43311 or GB44332
Exclusion
- 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
Key Trial Info
Start Date :
June 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT05878769
Start Date
June 28 2023
End Date
June 30 2027
Last Update
March 3 2026
Active Locations (482)
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1
UAB Lung Health Center
Birmingham, Alabama, United States, 35205-2610
2
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
Dothan, Alabama, United States, 36305
3
Jasper Summit Research LLC
Jasper, Alabama, United States, 35501
4
Pulmonary Associates of Mobile PC
Mobile, Alabama, United States, 36608-3135