ClinicalTrials.gov posted results on 15 October 2026 for a completed Phase 3 trial of itepekimab in chronic obstructive pulmonary disease (COPD). Among former smokers with moderate-to-severe COPD, the annualized rate of moderate or severe exacerbations was 0.650 with itepekimab 300 mg every two weeks and 0.708 every four weeks, compared with 0.891 with placebo.

Background

The study assessed itepekimab (also called SAR440340 or REGN3500) in former smokers with moderate-to-severe COPD. Its primary objective was to evaluate efficacy compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations. The supplied record does not provide drug-class or mechanism information, prior approvals, or disease-prevalence figures.

Trial design

This completed Phase 3 trial, NCT04701983, enrolled 1,127 participants. The listed interventions were placebo and itepekimab at 300 mg every two weeks or every four weeks. The primary objective concerned the annualized rate of moderate or severe exacerbations; secondary objectives included pulmonary function and exacerbation outcomes. The record’s primary-outcome list is empty.

Key results

For moderate or severe exacerbations, the reported annualized rates were 0.891 events per participant year with placebo, 0.708 with itepekimab every four weeks, and 0.650 every two weeks. The record lists corresponding dispersion entries as 95% confidence intervals, but supplies only one value for each: 0.763, 0.602, and 0.550, respectively.

Annualized severe-exacerbation rates were 0.142 events per participant year with placebo, 0.093 with itepekimab every four weeks, and 0.079 every two weeks. At week 24, pre-bronchodilator FEV1 changes were 0.026 liters with placebo, 0.035 liters every four weeks, and 0.032 liters every two weeks. E-RS:COPD total-score changes were -0.967, -1.540, and -1.716, respectively. The listed standard errors were 0.014 liters for each FEV1 result and 0.277, 0.274, and 0.275 for the symptom-score results.

The registry also reports four negative-binomial rate-ratio analyses: 0.795 (95% CI 0.654–0.966; p=0.0213), 0.729 (95% CI 0.598–0.89; p=0.0019), 0.659 (95% CI 0.43–1.012; p=0.0567), and 0.556 (95% CI 0.356–0.869; p=0.01). The supplied analysis entries do not identify the treatment-group contrasts for these estimates.

What this means

The posted group-level rates were lower with both itepekimab regimens than with placebo for moderate or severe and severe exacerbations. However, the registry data supplied here do not map the rate-ratio analyses to specific treatment comparisons, and several confidence-interval entries for event rates contain only one value. These limitations should be considered when interpreting the results; the record also provides no adverse-event summary.

Source

Source: ClinicalTrials.gov, registry results for “Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD),” posted 15 October 2026. Available at clinicaltrials.gov/study/NCT04701983.