AERIFY-1 results posted: itepekimab and COPD exacerbations in former smokers
On October 15, 2026, Sanofi's registry entry for the Phase 3 AERIFY-1 trial posted results. Both itepekimab doses lowered the annualized rate of moderate or severe exacerbations against placebo.
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On October 15, 2026, ClinicalTrials.gov first posted results for AERIFY-1 (NCT04701983), a Phase 3 study sponsored by Sanofi of itepekimab in moderate-to-severe chronic obstructive pulmonary disease (COPD). The record describes a randomized, double-blind, placebo-controlled, parallel group trial in former smokers. This story covers the posted registry record only, not any company statement, publication or regulatory filing.
How the trial ran
The record lists 1127 participants in the placebo-controlled analysis: 375 on placebo, 377 on itepekimab 300 mg every 4 weeks (Q4W) and 375 on itepekimab 300 mg every 2 weeks (Q2W). Itepekimab is described as an anti-IL-33 monoclonal antibody given as a subcutaneous injection. The Q4W group received alternating injections of placebo matching itepekimab, and treatment lasted up to 52 weeks.
The registry gives primary completion as April 11, 2025. The stated primary objective was to evaluate itepekimab against placebo on the annualized rate of acute moderate-or-severe COPD exacerbations.
The primary result
The record defines a moderate exacerbation as acute worsening of respiratory symptoms that required systemic corticosteroids, antibiotics or both. A severe exacerbation required hospitalization, observation for more than 24 hours in an emergency department or urgent care facility, or resulted in death. Events were adjudicated by a third party.
The annualized rate of adjudicated moderate or severe exacerbations was 0.891 events per participant year on placebo, 0.708 on itepekimab Q4W and 0.650 on itepekimab Q2W. Against placebo, the rate ratio was 0.795 for Q4W (95% confidence interval: 0.654 to 0.966; p = 0.0213) and 0.729 for Q2W (95% confidence interval: 0.598 to 0.890; p = 0.0019). The record says a hierarchical testing procedure controlled the overall type I error, and that the primary measure was tested at a 2-sided significance level of 0.049.
Severe exacerbations
For severe exacerbations alone, the annualized rate was 0.142 on placebo, 0.093 on Q4W and 0.079 on Q2W. The rate ratio against placebo was 0.659 for Q4W (95% confidence interval: 0.430 to 1.012; p = 0.0567) and 0.556 for Q2W (95% confidence interval: 0.356 to 0.869; p = 0.0100). The Q4W interval includes 1, so the record does not show a difference for that dose on severe exacerbations.
Safety entries in the record
The adverse events section analyzes the safety population: 374 on placebo, 377 on Q4W and 374 on Q2W. It lists 9 deaths on placebo, 4 on Q4W and 5 on Q2W. Serious adverse events affected 82 participants on placebo, 72 on Q4W and 68 on Q2W.
What the record does not say
The posted record is a registry entry. It is not a peer-reviewed paper and it is not a regulatory decision. The story relies only on the numbers the sponsor posted there.