Study Design
DesignRandomized, double-blind, placebo-controlled, multicenter
Randomization1:1:1
BlindingDouble-blind
Enrollment1127
Duration52 weeks
Treatment Arms
Itepekimab Q2W 300mg SC Q2W n=375
Itepekimab Q4W 300mg SC Q4W n=377
Placebo Matching placebo n=375
[{"id":"aerify1-aer","name":"Annualized moderate-to-severe COPD exacerbation rate at Week 52","type":"PRIMARY","unit":"rate ratio","results":[{"notes":"27% reduction vs placebo — STATISTICALLY SIGNIFICANT","value":null,"arm_id":"itepe-q2w-aerify1","arm_name":"Itepekimab Q2W"},{"notes":"21% reduction vs placebo — STATISTICALLY SIGNIFICANT","value":null,"arm_id":"itepe-q4w-aerify1","arm_name":"Itepekimab Q4W"}],"timepoint":"Week 52","description":"Annualized rate of moderate-to-severe COPD exacerbations in former smokers with moderate-to-severe COPD on maintenance inhaled therapy."}]
AERIFY-1 MET primary endpoint: 27% reduction in COPD exacerbations with Q2W (significant), 21% with Q4W (significant). First Phase 3 to show anti-IL-33 reduces COPD exacerbations in former smokers. Effect size (27%) is competitive with Dupixent (30% in eos≥300) but in a NON-eosinophil-selected population.
AERIFY-1 is the key positive result. 27% in a non-eosinophil-selected former-smoker population. If regulatory path works out, this could be a broader market than Dupixent-in-COPD (eos≥300 only). The Q4W dosing (21%) is also significant — enables monthly dosing for convenience.