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Evaluating astegolimab for chronic obstructive pulmonary disease

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

Phase 3 Interventional Hoffmann-La Roche · NCT05595642

This study is testing if a new medication called astegolimab can help people with chronic obstructive pulmonary disease (COPD) who smoke or used to smoke by reducing their symptoms and flare-ups.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1290 (estimated)
Ages40 Years to 80 Years
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsastegolimab
Locations462 sites (Anniston, Alabama and 461 other locations)
Trial IDNCT05595642 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of astegolimab compared to a placebo in individuals with chronic obstructive pulmonary disease (COPD) who are current or former smokers and have experienced frequent exacerbations. Participants must have a documented COPD diagnosis for at least 12 months and meet specific criteria regarding their lung function and exacerbation history. The study aims to determine if astegolimab can provide significant improvements in managing COPD symptoms and reducing exacerbations.

Who should consider this trial

Good fit: Ideal candidates include individuals with a documented COPD diagnosis, a history of frequent exacerbations, and who are current or former smokers.

Not a fit: Patients who do not have COPD or those with stable COPD not experiencing frequent exacerbations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to better management of COPD symptoms and fewer exacerbations for patients.

How similar studies have performed: Other studies have shown promise in targeting COPD with novel therapies, but the specific approach with astegolimab is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Anniston, Alabama and 461 other locations

+412 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Obstructive Pulmonary Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.