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A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
- Chronic Obstructive Pulmonary Disease
Trial Status:
Not yet recruiting
This trial runs in
Cities
Trial Identifier:
NCT05878769 GB43374
Trial 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 placebo-controlled treatment period in parent studies GB43311 or GB44332.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT05878769 , GB43374
Trial Identifier
Astegolimab
Treatments
Chronic Obstructive Pulmonary Disease
Condition
Official Title
A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
Eligibility Criteria
All
Gender
≥40 Years & ≤ 90 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Completion of the 52-week treatment period in either parent GB43311 or GB44332
Exclusion Criteria
- 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
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