A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
Hoffmann-La Roche
Summary
This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.
Eligibility
- Age range
- 40–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Documented COPD diagnosis for ≥ 12 months * History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening * Post-bronchodilator FEV1 ≥ 20% and \< 80% of predicted at screening * Post-bronchodilator FEV1/FVC \< 0.70 at screening * Modified Medical Research Council (dyspnea scale) (mMRC) score ≥ 2 * Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years * On optimized COPD maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current the…
Interventions
- DrugAstegolimab
Participants will receive SC astegolimab Q2W or Q4W
- DrugPlacebo
Participants will receive SC placebo Q2W
Locations (462)
- Pinnacle Research GroupAnniston, Alabama
- AllerVie Clinical ResearchBirmingham, Alabama
- Synexus Clinical Research US, Inc. - BirminghamBirmingham, Alabama
- University of Alabama at BirminghamBirmingham, Alabama
- SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDSDothan, Alabama
- Pulmonary Associates PAGlendale, Arizona