Status:
RECRUITING
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief 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 his...
Eligibility Criteria
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 therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA
- Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD
Exclusion Criteria
- Current documented diagnosis of asthma
- History of clinically significant pulmonary disease other than COPD
- Diagnosis of 1-antitrypsin deficiency
- History of long-term treatment with oxygen at > 4.0 liters/minute
- Lung volume reduction surgery or procedure within 12 months prior to screening
- Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible)
- History of lung transplant
- Any infection that resulted in hospital admission for ≥ 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening
- Upper or lower respiratory tract infection within 4 weeks prior to or during screening
- Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
- Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening
- Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening
Key Trial Info
Start Date :
December 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 24 2027
Estimated Enrollment :
1290 Patients enrolled
Trial Details
Trial ID
NCT05595642
Start Date
December 29 2022
End Date
September 24 2027
Last Update
April 2 2026
Active Locations (462)
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1
Pinnacle Research Group
Anniston, Alabama, United States, 36207-4781
2
AllerVie Clinical Research
Birmingham, Alabama, United States, 35209-6802
3
Synexus Clinical Research US, Inc. - Birmingham
Birmingham, Alabama, United States, 35211-1320
4
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294