Recruiting NCT05878769

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

Phase III Interventional Chronic Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Astegolimab.
Who it may be relevant to: Registry conditions: Chronic Obstructive Pulmonary Disease. Basic parameters: 40 years — 90 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +35
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

Overview

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.

Interventions

Drug Astegolimab
Participants will receive SC astegolimab Q2W

Primary outcome measures

Incidence of all adverse events (AEs) [Time frame: Up to 12 weeks after last dose of study treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 68 centers

UAB Lung Health Center — Birmingham
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS — Dothan
Jasper Summit Research LLC — Jasper
Pulmonary Associates of Mobile PC — Mobile
Pulmonary Associates Deer Valley Office — Phoenix
AES - DRS - Synexus Clinical Research US, Inc. - Tucson — Tucson
Kern Allergy and Medical Research — Bakersfield
Cadena Care Institute, LLC — Poway
… and 60 more centers

Argentina · 40 centers

Centro Medico Capital — La Plata
CEMLO - Centro de Especialidades Médicas Lobos - Patagones 94 — Lobos
Consultorios Medicos Organizacion de Buen Ayre SRL — Buenos Aires
Centro de Investigaciones Clínicas Belgrano — Buenos Aires
Fundacion Cidea — Buenos Aires
Fundacion Faicep — Buenos Aires
Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias — Buenos Aires
AES - AS - Glenny Corp. S.A. Buenos Aires — Buenos Aires
… and 32 more centers

China · 36 centers