A Phase 3 interventional study of Astegolimab and Placebo in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Hoffmann-La Roche. Active, not recruiting at 382 sites in 36 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's planned enrollment of 1,290 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W)
Drug: Astegolimab
Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W.
Drug: Astegolimab
Participants will receive SC placebo Q2W
Drug: Placebo
Participants will receive SC astegolimab Q2W or Q4W
Participants will receive SC placebo Q2W
Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period
Time frame: 52 weeks
Time to first moderate or severe COPD exacerbation during the 52-week treatment period
Time frame: 52 weeks
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
Time frame: Week 52
Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52
Time frame: Week 52
Absolute change from baseline in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) total score at Week 52
Time frame: Week 52
Proportion of participants with improvement in HRQoL at Week 52
Time frame: Week 52
Annualized rate of severe COPD exacerbations over the 52-week treatment period
Time frame: 52 weeks
Showing the first 100 of 382 sites across 36 countries.
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
Hoffmann-La Roche