A Study to Evaluate the Long-Term Safety of Astegolimab in Patients with Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 21.1Level: PTClassification code: 10009033Term: Chronic obstructive pulmonary disease Class: 100000004855Therapeutic area: Health Care [N] - Environment and Public Health [N06]Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2022-502501-15-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1561
Ability to comply with the requirements of the study protocol, according to the investigator’s best judgment, Completion of the 52-week treatment period in either Study GB43311 or Study GB44332
Any permanent discontinuation of study drug in 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, Any new clinically significant pulmonary disease other than COPD since enrolling in the parent study, Any other new serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study since enrolling in the parent study, History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of astegolimab, QT interval corrected through use of Fredericia’s formula (QTcF) > 450ms if patient is male of QTcF > 470ms if patient is female. For male or female patients with QRS > 120ms: QTcF > 480ms
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method