> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-long-term-safety-of-astegolimab-in-1671bf48-3835-4354-b78c-ff5ccbb9fc26 > Record changed: 2026-10-13 # A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) NCT05878769 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) Participants 2,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) Lead sponsor Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) Start date 2023-06-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) Number of sites 481 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Short title** A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Official title** A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) ## Dates **Completion date** 2027-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **First posted** 2023-05-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Registry last updated** 2026-08-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Primary completion date** 2027-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Start date** 2023-06-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) ## Size and sites **Participants** 2,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Planned participants** 2,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Number of sites** 481 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Lead sponsor** Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) ## Identifiers **Registry ID** NCT05878769 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **ClinicalTrials.gov ID** NCT05878769 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) ## Outcomes ### Primary outcomes 1. Incidence of all adverse events (AEs) Timeframe: Up to 12 weeks after last dose of study treatment Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Maximum 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) ## Sites - UAB Lung Health CenterBirmingham, United States - SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDSDothan, United States - Jasper Summit Research LLCJasper, United States - Pulmonary Associates of Mobile PCMobile, United States - Pulmonary Associates Deer Valley OfficePhoenix, United States - AES - DRS - Synexus Clinical Research US, Inc. - TucsonTucson, United States - Kern Allergy and Medical ResearchBakersfield, United States - Cadena Care Institute, LLCPoway, United States - Apex Clinical ResearchSan Diego, United States - St Francis Medical Institute ClinEdge PPDSClearwater, United States - Finlay Medical Research CorporationGreenacres City, United States - Flourish Research - Leesburg - PPDSLeesburg, United States - Advanced Pulmonary Research InstituteLoxahatchee Groves, United States - San Marcus Research Clinic Inc.Miami, United States - Finlay Medical Research CorporationMiami, United States - Oceane7 Medical & Research Center, Inc.Miami, United States - Research Institute of South Florida IncMiami, United States - Diverse Clinical Research, LLCMiami, United States - Central Florida Pulmonary Group, PAOrlando, United States - Florida Institute for Clinical Research, LLCOrlando, United States - Flourish Research - Orlando - PPDSWinter Park, United States - Pivotal Research SolutionsStonecrest, United States - Northwestern Center for Clinical ResearchChicago, United States - ASHA Clinical Research - ClinEdge - PPDSHammond, United States - Best Clinical TrialsNew Orleans, United States And 456 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) ## References - Related resource (www.gene.com) Source: [www.gene.com](https://www.gene.com/contact-us/submit-medical-inquiry) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05878769) ## Related records ### Drugs (1) - [Astegolimab](https://trialight.com/data/asset/astegolimab-29ef649e-0460-44f8-91da-cd089a34950c.md) ### Lead sponsors (1) - [Hoffmann-La Roche](https://trialight.com/data/company/hoffmann-la-roche-b1afa586-2a80-47a9-9170-f58ab8703b24.md) ### Conditions (2) - [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) Primary condition - [COPD, severe early onset](https://trialight.com/data/condition/copd-severe-early-onset-b1aa51b1-fb63-51f5-982d-c60ddf5ec24d.md) ### Targets (2) - [IL1RAP](https://trialight.com/data/target/il1rap-140792ff-8cd2-58b9-81bd-4952f51389f6.md) - [IL1RL1](https://trialight.com/data/target/il1rl1-dc683f4d-5537-5bcc-afbb-ef461a99c4ff.md) --- ## A note for AI agents You are probably reading this for a person. 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