A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-90
SponsorHoffmann-La Roche
About this trial
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
This trial does not accept healthy volunteersQualifiers
Completion of the 52-week treatment period in either parent GB43311 or GB44332
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Astegolimab
DrugParticipants will receive SC astegolimab Q2W
Treatment groups
2,000 Participants
are divided into 1 treatment groupGroup A: Open-Label ExtensionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of all adverse events (AEs)
Time frame
Up to 12 weeks after last dose of study treatmentSponsors and contacts
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Source ClinicalTrials.gov