A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.

Timeline

Start

2021-10-05

Primary completion

2025-02-24

Completion

2025-07-07

Outcome

Met primary endpoint

paper 0·85 (95% CI 0·72-1·00; p=0·049) for astegolimab every 2 weeks PMID 42150581 ↗

release “The pivotal Phase IIb ALIENTO study met its primary endpoint” gene.com ↗

Publications

• Papi A, Greening NJ, Bhatt SP, Roche N, Celli B, Wedzicha JA, Agusti A, Tal-Singer R, Han MK, Janssens W, Hanania NA, Nair P, Bremner P, Porpodis K, Shibata Y, Korn S, Yang T, Gordon O, Saenz R, Ng J, Cheung DS, Devine J, Grimbaldeston MA, Zhang W, Yang X, Mohan D, Vogelmeier CF, Brightling CE; ALIENTO and ARNASA investigators. Safety and efficacy of astegolimab for COPD with frequent exacerbations regardless of baseline blood eosinophil counts (ALIENTO and ARNASA): randomised, double-blind, placebo-controlled, phase 2b and 3 trials. Lancet. 2026 May 23;407(10543):2027-2039. doi: 10.1016/S0140-6736(26)00637-9. Epub 2026 May 18.
• Wedzicha JA, Agusti A, Brightling CE, Calverley P, Chalmers JD, Greening NJ, Han MK, Mohan D, Ng J, Papi A, Roche N, Saenz R, Samara K, Tal-Singer R, Vogelmeier CF, Yang X, Celli BR. Astegolimab for COPD With Frequent Exacerbations: Pooled Analysis of the ALIENTO and ARNASA Trials. Am J Respir Crit Care Med. 2026 May 18:aamag226. doi: 10.1093/ajrccm/aamag226. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Astegolimab	Monoclonal antibody	476 mg	Subcutaneous

Indications