A Study to Evaluate the Efficacy and Safety of Astegolimab in Patients with Chronic Obstructive Pulmonary Disease (COPD)

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 21.1Level: LLTClassification code 10077773Term: Chronic obstructive pulmonary disease exacerbationSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-002045-15-DE
• Lead Sponsor: Genentech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-04
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1290

Inclusion Criteria

•Age 40-90 years
•Documented physician diagnosis of COPD for at least 12 months
•History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening
•Post-bronchodilator FEV1 >=20 and <80% of predicted normal value at screening
•Modified Medical Research Council (dyspnea scale) (mMRC) score >=2
•Current or former smoker with a minimum of 10 pack-year history
•History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study:
-Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA)
-Long-acting muscarinic antagonist (LAMA) plus LABA
-ICS plus LAMA plus LABA
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 645
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 645

Exclusion Criteria

•Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening
•History of clinically significant pulmonary disease other than COPD
•History of long-term treatment with oxygen at >4.0 liters/minute
•Lung volume reduction surgery or procedure within 12 months prior to screening
•Participation in or planned participation in a new pulmonary rehabilitation program. Patients who are in the maintenance phase of a rehabilitation program are eligible
•History of lung transplant
•Occurrence of moderate or severe COPD exacerbation, COVID-19, upper or lower respiratory infection, pneumonia, or hospitalization of 24 hours duration within 4 weeks prior to initiation of study drug
•Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
•Initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or PDE4 inhibitor within 4 weeks 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified