A Study to Evaluate the Efficacy and Safety of Astegolimab in Patientswith Chronic Obstructive Pulmonary Disease

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 21.1Level: PTClassification code: 10009033Term: Chronic obstructive pulmonary disease Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2022-502234-70-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-07
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1198

Inclusion Criteria

Documented COPD diagnosis for >= 12 months prior to Visit 1, History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to Visit 1, Post-bronchodilatir FEV1 >= 20% and < 80% of predicted and FEV1/ forced vital capacity (FVC) < 0.70 at Visit 1 or Visit 2, mMRC score >= 2 at screening, Current tobacco smoker or former smoker (having stopped smoking for at least 6 months prior to Visit 1) with a history of smoking >= 10 pack-years (e.g., 20 cigarettes/day for 10 years), On optimized COPD maintenance therapy of inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA) plus LABA, or ICS plus LAMA plus LABA for >= 12 months prior to Visit 1

Exclusion Criteria

Age 40-80 years at Visit 1, History of clinically significant pulmonary disease other than COPD, History of long-term treatment with oxygen at > 4.0 liters/minute. While breathing supplemental oxygen, the participant should demonstrate an oxyhemoglobin saturation of >= 89%, Lung volume reduction surgery or procedure within 12 months prior to Visit 1, Any other serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant’s safe participation in and completion of the study, Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening, Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 12 weeks after the final dose of astegolimab

Study & Design

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