ClinicalTrials.gov posted results on 31 August 2026 for a completed study of itepekimab (SAR440340) in chronic obstructive pulmonary disease. The exploratory, two-part Phase 2a study enrolled 49 participants and assessed airway inflammation over 12 weeks in former and current smokers with COPD.

Reported Week 12 findings included median changes in pharmacodynamic normalized enrichment scores from endobronchial biopsies of 0.691 in former smokers and 0.526 in current smokers. The registry did not provide p-values, confidence intervals, comparative analyses, or an adverse-event summary.

Background

Itepekimab was studied as an anti-IL-33 monoclonal antibody in people with COPD. Participants were former or current smokers aged 40 to 70 years who had been receiving standard-of-care COPD controller therapy before screening. The listed controller regimens included single, dual, or triple therapy involving long-acting beta agonists, long-acting muscarinic antagonists, and inhaled corticosteroids.

Trial design

This was an exploratory, two-part, Phase 2a, 12-week study of the mechanism of action of itepekimab and its impact on airway inflammation. It enrolled 49 participants with COPD and included separate groups for former smokers and current smokers. The supplied record listed itepekimab SAR440340 as the intervention and the overall study status as completed.

The reported measurements examined pharmacodynamic normalized enrichment scores in endobronchial biopsies, bronchial brushings, and nasal brushings. Additional outcomes assessed interleukin-33-treated eosinophil-associated and mast cell-associated normalized enrichment scores in endobronchial biopsies, as well as blood eosinophil counts. No primary outcome entries or comparator arm were supplied.

Key results

  • For the pharmacodynamic score derived from former smokers in endobronchial biopsies, the median change was 0.691 score in Part A, the former-smoker group, and 0.526 score in Part B, the current-smoker group.
  • In bronchial brushings, the corresponding median changes were 0.534 score and 0.270 score.
  • In nasal brushings, median changes were -0.051 score in former smokers and 0.190 score in current smokers.
  • The median change in the IL-33-treated eosinophil-associated score from endobronchial biopsies was -0.095 score in former smokers and -0.006 score in current smokers. The mast cell-associated score changed by -0.327 score and -0.044 score, respectively.
  • Mean blood eosinophil counts changed by -0.06 × 10^9 cells/liter with a standard deviation of 0.13 in former smokers, and by -0.04 × 10^9 cells/liter with a standard deviation of 0.11 in current smokers.

What this means

The posted measurements describe airway and blood biomarker changes after 12 weeks of itepekimab study treatment in two smoking-status groups. They provide exploratory mechanistic data for COPD, but the supplied record does not establish clinical efficacy, comparative benefit, statistical significance, or a treatment-related safety profile.

Source

Source: ClinicalTrials.gov, registry record for the “Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD,” NCT05326412, with results posted on 31 August 2026. The record is available at clinicaltrials.gov/study/NCT05326412.