> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-astegolimab-in-participants-with-chronic-8e6922e8-89e1-4070-b3b2-33d3efcab415 > Record changed: 2026-10-13 # A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease NCT05595642 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) Participants 1,290 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) Lead sponsor Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) Start date 2022-12-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) Number of sites 382 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) ## Title and summary **Summary** This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Acronym** ARNASA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Short title** A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Official title** A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) ## Dates **Completion date** 2027-09-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **First posted** 2022-10-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Registry last updated** 2026-05-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Primary completion date** 2025-06-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Start date** 2022-12-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) ## Size and sites **Participants** 1,290 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Planned participants** 1,290 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Number of sites** 382 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Lead sponsor** Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) ## Identifiers **Registry ID** NCT05595642 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **ClinicalTrials.gov ID** NCT05595642 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) ## Outcomes ### Primary outcomes 1. Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period Timeframe: 52 weeks ### Secondary outcomes 1. Time to first moderate or severe COPD exacerbation during the 52-week treatment period Timeframe: 52 weeks 2. Absolute change from baseline in health-related quality of life (HRQoL) at Week 52 as assessed through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score Timeframe: Week 52 3. Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52 Timeframe: Week 52 4. Absolute change from baseline in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) total score at Week 52 Timeframe: Week 52 5. Proportion of participants with improvement in HRQoL at Week 52 Timeframe: Week 52 6. Annualized rate of severe COPD exacerbations over the 52-week treatment period Timeframe: 52 weeks Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Maximum age** 80 Years **Healthy volunteers** No ### Inclusion criteria - Documented COPD diagnosis for ≥ 12 months - History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening - Post-bronchodilator FEV1 ≥ 20% and < 80% of predicted at screening - Post-bronchodilator FEV1/FVC < 0.70 at screening - Modified Medical Research Council (dyspnea scale) (mMRC) score ≥ 2 - Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years - On optimized COPD maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA - Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD ### Exclusion criteria - Current documented diagnosis of asthma - History of clinically significant pulmonary disease other than COPD - Diagnosis of 1-antitrypsin deficiency - History of long-term treatment with oxygen at > 4.0 liters/minute - Lung volume reduction surgery or procedure within 12 months prior to screening - Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible) - History of lung transplant - Any infection that resulted in hospital admission for ≥ 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening - Upper or lower respiratory tract infection within 4 weeks prior to or during screening - Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug - Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening - Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) ## Sites - University of Alabama at BirminghamBirmingham, United States - SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDSDothan, United States - Pulmonary Associates PAGlendale, United States - AES - DRS - Synexus Clinical Research US, Inc. - TucsonTucson, United States - Kern ResearchBakersfield, United States - Allergy & Asthma Medical Group of the Bay AreaWalnut Creek, United States - Finlay Medical Research CorporationGreenacres City, United States - San Marcus Research Clinic Inc.Miami, United States - Oceane7 Medical & Research Center, Inc.Miami, United States - Avantis Clinical Research, LLCMiami, United States - Research Institute of South Florida IncMiami, United States - Diverse Clinical Research, LLCMiami, United States - Central Florida Pulmonary Group, PAOrlando, United States - AES - DRS - Synexus Clinical Research US, Inc. - The VillagesThe Villages, United States - AES - DRS - Synexus Clinical Research US, Inc. - AtlantaAtlanta, United States - Allergy Center at Brookstone Research - Centricity Research - HyperCore - PPDColumbus, United States - Pivotal Research SolutionsStonecrest, United States - ASHA Clinical Research - ClinEdge - PPDSHammond, United States - The Research Group of Lexington, LLCLexington, United States - Best Clinical TrialsNew Orleans, United States - Paul A. Shapero, MD, PABangor, United States - Pulmonary Research Institute of Southeast MichiganFarmington Hills, United States - Flushing Road Internal Medicine and Pediatrics - FFlint, United States - Revive Research InstituteLathrup Village, United States - Oakland Medical Research CenterTroy, United States And 357 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) ## References - PubMed 42150581 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42150581/) Related publication - PubMed 42148875 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42148875/) Related publication ### Other registry identifiers - 2022-502234-70-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05595642) ## 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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