A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT05878769
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- Astegolimab — DRUGParticipants will receive SC astegolimab Q2W
Study Details
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.
Key Dates
- First listed
- May 26, 2023
- Start date
- Jun 28, 2023
- Status verified
- Aug 2026
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 2,000 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Open-Label ExtensionEligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study
Primary Outcome Measure
Incidence of all adverse events (AEs) [ Time Frame: Up to 12 weeks after last dose of study treatment ]
Locations (68)
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UAB Lung Health Center· Birmingham, ALSEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS· Dothan, ALJasper Summit Research LLC· Jasper, ALPulmonary Associates of Mobile PC· Mobile, ALPulmonary Associates Deer Valley Office· Phoenix, AZAES - DRS - Synexus Clinical Research US, Inc. - Tucson· Tucson, AZ
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