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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease, COPD

Brief 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.

Papi A, Greening NJ, Bhatt SP, Roche N, Celli B, Wedzicha JA, Agustí À, 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.

2026-05-18

10.1016/s0140-6736(26)00637-9

Astegolimab for COPD With Frequent Exacerbations: Pooled Analysis of the ALIENTO and ARNASA Trials.

Wedzicha JA, Agustí À, 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.

2026-05-18

10.1093/ajrccm/aamag226

ALIENTO and ARNASA: Study designs of two randomised, double-blind, placebo-controlled trials of astegolimab in patients with COPD

Christopher E. Brightling, James D. Chalmers, Parameswaran Nair, Neil Greening, Russell P. Bowler et al. (10 authors)

2023-09-092 citations

10.1183/13993003.congress-2023.pa1292

Interventions

DRUGAstegolimab

Participants will receive SC astegolimab Q2W or Q4W.

DRUGPlacebo

Participants will receive SC placebo Q2W.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

Healthy volunteers

No

Inclusion criteria

* Documented physician diagnosis of COPD for at least 12 months * History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening * Post-bronchodilator FEV1 \>=20 and \<80% of predicted normal value at screening * Modified Medical Research Council (dyspnea scale) (mMRC) score \>=2 * Current or former smoker with a minimum of 10 pack-year history * History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA); Long-acting muscarinic antagonist (LAMA) plus LABA; ICS plus LAMA plus LABA

Exclusion criteria

* Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening * History of clinically significant pulmonary disease other than COPD * History of long-term treatment with oxygen at \>4.0 liters/minute * Lung volume reduction surgery or procedure within 12 months prior to screening * Participation in or planned participation in a new pulmonary rehabilitation program. Patients who are in the maintenance phase of a rehabilitation program are eligible * History of lung transplant * Occurrence of moderate or severe COPD exacerbation, COVID-19, upper or lower respiratory infection, pneumonia, or hospitalization of 24 hours duration within 4 weeks prior to initiation of study drug * Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug * Initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or PDE4 inhibitor within 4 weeks 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

Design outcomes

Primary

Measure	Time frame
Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-Week Treatment Period	Baseline up to Week 52

Secondary

Measure	Time frame
Time to First Moderate or Severe COPD Exacerbation During the 52-Week Treatment Period	Baseline up to Week 52
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	Baseline to Week 52
Proportion of SGRQ-C Responders at Week 52	Baseline to Week 52
Absolute Change from Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (liters) at Week 52	Baseline to Week 52
Absolute Change from Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Score at Week 52	Baseline to Week 52
Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period	Baseline up to Week 52
Absolute Change from Baseline in Five-Repetition Sit-to-Stand (5STS) time (seconds) at Week 52	Baseline to Week 52

Countries

Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Czechia, Denmark, France, Germany, Hong Kong, Israel, Mexico, Netherlands, New Zealand, Peru, Poland, Romania, South Africa, South Korea, Spain, Sweden, United Kingdom, United States

Contacts

STUDY_DIRECTORClinical Trials

Hoffmann-La Roche

Outcome results

None listed