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A clinical trial to look at how safe astegolimab is when given over a long period of time for people with chronic obstructive pulmonary disease by measuring the number and seriousness of side effects
A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Respiratory Disorder Chronic Obstructive Pulmonary Disease (COPD)
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Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Study Identifier
NCT05878769, GB43374, 2022-502501-15-00
Condition
Chronic Obstructive Pulmonary Disease
Official Title
A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
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 Criteria
All
≥40 Years & ≤ 90 Years
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
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com