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Clinical Trials in the UK / NCT05878769
Active, not recruiting Phase 3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2023-06-28
Last updated
2026-08-14

Condition(s) studied

Chronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

Astegolimab

Astegolimab: Participants will receive SC astegolimab Q2W

Study summary

The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.

Eligibility

Sex
ALL
Min age
40 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * Completion of the 52-week treatment period in either parent GB43311 or GB44332 Exclusion Criteria: * Withdrawal of consent and/or premature discontinuation from parent study * Any permanent discontinuation of study drug in parent study * Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment * Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study * Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study * Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study

Primary outcome measure(s)

Trial sites (481)

FacilityCityRegionStatus
UAB Lung Health Center Birmingham Alabama
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS Dothan Alabama
Jasper Summit Research LLC Jasper Alabama
Pulmonary Associates of Mobile PC Mobile Alabama
Pulmonary Associates Deer Valley Office Phoenix Arizona
AES - DRS - Synexus Clinical Research US, Inc. - Tucson Tucson Arizona
Kern Allergy and Medical Research Bakersfield California
Cadena Care Institute, LLC Poway California
Apex Clinical Research San Diego California
St Francis Medical Institute ClinEdge PPDS Clearwater Florida
Finlay Medical Research Corporation Greenacres City Florida
Flourish Research - Leesburg - PPDS Leesburg Florida
Advanced Pulmonary Research Institute Loxahatchee Groves Florida
San Marcus Research Clinic Inc. Miami Florida
Finlay Medical Research Corporation Miami Florida
Oceane7 Medical & Research Center, Inc. Miami Florida
Research Institute of South Florida Inc Miami Florida
Diverse Clinical Research, LLC Miami Florida
Central Florida Pulmonary Group, PA Orlando Florida
Florida Institute for Clinical Research, LLC Orlando Florida
Flourish Research - Orlando - PPDS Winter Park Florida
Pivotal Research Solutions Stonecrest Georgia
Northwestern Center for Clinical Research Chicago Illinois
ASHA Clinical Research - ClinEdge - PPDS Hammond Indiana
Best Clinical Trials New Orleans Louisiana
Paul A. Shapero, MD, PA Bangor Maine
Exordia Medical Research, Inc. Fall River Massachusetts
Pulmonary Research Institute of Southeast Michigan Farmington Hills Michigan
Flushing Road Internal Medicine and Pediatrics - F Flint Michigan
Revive Research Institute Southfield Michigan
Oakland Medical Research Center Troy Michigan
The Lung Research Center Chesterfield Missouri
Hannibal Regional Healthcare System HRMG Hannibal Hannibal Missouri
Midwest Chest Consultants Saint Charles Missouri
Washington University School of Medicine in St. Louis St Louis Missouri
Midwest Clinical Research LLC St Louis Missouri
The Machuca Foundation Inc Las Vegas Nevada
Sierra Clinical Research - ClinEdge - PPDS Las Vegas Nevada
Renown Regional Medical Center Hospital Reno Nevada
AES - DRS - Synexus Clinical Research US, Inc. - New York New York New York

+ 441 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 NCT05878769 on ClinicalTrials.gov ↗ ← All trials in the UK