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Rationale The randomised, double-blind, placebo-controlled Phase IIb ALIENTO trial ( NCT05037929) evaluated efficacy and safety of astegolimab (anti-ST2) in COPD.Methods Participants (current/former smokers, aged 40–90 years, history of frequent exacerbations) were randomised 1:1:1 to astegolimab SC 476 mg Q2W or Q4W, or placebo, for 52 weeks. Efficacy and safety endpoints were evaluated.Results 1301 participants were treated (Q2W, n=433; Q4W, n=437; placebo, n=431; 79% on ICS/LABA/LAMA at baseline). Annualised rate of moderate/severe COPD exacerbations (primary endpoint) was significantly lower with astegolimab Q2W vs placebo (adjusted rate reduction 15%; P=0.0494), but not Q4W vs placebo (figure 1). There were numerical decreases with astegolimab Q2W in moderate/severe COPD exacerbation rate in participants with baseline EOS <300 cells/µL (RR 0.87 [95% CI 0.73, 1.04]; P=0.1210), severe exacerbation rate (RR 0.71 [95% CI 0.49, 1.05]; P=0.0883), and change from baseline to Week 52 in SGRQ-C (difference in adjusted mean –1.87 [95% CI –4.01, 0.26]; P=0.0857). No differences were seen in other secondary endpoints (Week 52). Adverse events were balanced between treatment arms.Abstract S1 Figure 1Conclusions Astegolimab Q2W decreased annualised COPD exacerbation rate by 15% ( P=0.0494) vs placebo in the overall ALIENTO population (irrespective of smoking status or EOS level), with trends for improvement in some other clinical outcomes.