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 exacerbation Class: 10038738
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Therapeutic area: Phenomena and Processes [G] - Immune System Phenomena [G13]

Registration Number: CTIS2023-507093-40-00

Lead Sponsor: Genentech Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1289

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, 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

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, Lung volume reduction surgery or procedure within 12 months prior to screening, 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, History of long-term treatment with oxygen at > 4.0 liters/minute. While breathing supplemental oxygen, patient should demonstrate an oxyhemoglobin saturation of >= 89%