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A clinical trial to see how well different doses of astegolimab plus standard treatment work compared with a placebo plus standard treatment to reduce certain symptoms of chronic obstructive pulmonary disease
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
Respiratory Disorder Chronic Obstructive Pulmonary Disease (COPD)
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Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Study Identifier
NCT05595642, GB44332, 2022-502234-70-00
Condition
Chronic Obstructive Pulmonary Disease (COPD)
Official Title
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
Study 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 Criteria
All
≥40 Years & ≤ 80 Years
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 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
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com