A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
Hoffmann-La Roche
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.
Eligibility
- Age range
- 40–90 years
- Sex
- All
- Healthy volunteers
- No
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 th…
Interventions
- DrugAstegolimab
Participants will receive SC astegolimab Q2W
Locations (484)
- UAB Lung Health CenterBirmingham, Alabama
- SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDSDothan, Alabama
- Jasper Summit Research LLCJasper, Alabama
- Pulmonary Associates of Mobile PCMobile, Alabama
- Pulmonary Associates Deer Valley OfficePhoenix, Arizona
- AES - DRS - Synexus Clinical Research US, Inc. - TucsonTucson, Arizona