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Clinical Trials in the UK / NCT05595642
Active, not recruiting Phase 3

A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

NCT05595642 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2022-12-29
Last updated
2026-05-20

Condition(s) studied

Chronic Obstructive Pulmonary Disease (COPD)

Investigational drug(s) / intervention(s)

AstegolimabPlacebo

Astegolimab: Participants will receive SC astegolimab Q2W or Q4W

Placebo: Participants will receive SC placebo Q2W

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

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
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

Primary outcome measure(s)

Trial sites (382)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS Dothan Alabama
Pulmonary Associates PA Glendale Arizona
AES - DRS - Synexus Clinical Research US, Inc. - Tucson Tucson Arizona
Kern Research Bakersfield California
Allergy & Asthma Medical Group of the Bay Area Walnut Creek California
Finlay Medical Research Corporation Greenacres City Florida
San Marcus Research Clinic Inc. Miami Florida
Oceane7 Medical & Research Center, Inc. Miami Florida
Avantis Clinical Research, LLC Miami Florida
Research Institute of South Florida Inc Miami Florida
Diverse Clinical Research, LLC Miami Florida
Central Florida Pulmonary Group, PA Orlando Florida
AES - DRS - Synexus Clinical Research US, Inc. - The Villages The Villages Florida
AES - DRS - Synexus Clinical Research US, Inc. - Atlanta Atlanta Georgia
Allergy Center at Brookstone Research - Centricity Research - HyperCore - PPD Columbus Georgia
Pivotal Research Solutions Stonecrest Georgia
ASHA Clinical Research - ClinEdge - PPDS Hammond Indiana
The Research Group of Lexington, LLC Lexington Kentucky
Best Clinical Trials New Orleans Louisiana
Paul A. Shapero, MD, PA Bangor Maine
Pulmonary Research Institute of Southeast Michigan Farmington Hills Michigan
Flushing Road Internal Medicine and Pediatrics - F Flint Michigan
Revive Research Institute Lathrup Village Michigan
Oakland Medical Research Center Troy Michigan
Washington University School of Medicine in St. Louis St Louis Missouri
Nebraska Medical Research Institute, Inc. - CRN Bellevue Nebraska
Machuca Family Medicine Las Vegas Nevada
Renown Regional Medical Center Hospital Reno Nevada
Hassman Research Institute - HRI - Berlin - CenExel - PPDS Marlton New Jersey
AES - DRS - Synexus Clinical Research US, Inc. - New York New York New York
Research Carolina Elite Denver North Carolina
Pulmonix LLC Greensboro North Carolina
Advanced Respiratory and Sleep Medicine, PLLC Huntersville North Carolina
Southeastern Research Center Winston-Salem North Carolina
OK Clinical Research Edmond Oklahoma
The Oregon Clinic Portland Oregon
Clinical Research Associates Of Central Pa , Llc Altoona Pennsylvania
Allergy & Clinical Immun Assoc Pittsburgh Pennsylvania
Medtrial, LLC Columbia South Carolina

+ 342 more sites — see the full list on the official registry below.

More Hoffmann-La Roche trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05595642 on ClinicalTrials.gov ↗ ← All trials in the UK