Itepekimab Phase 3 Trial for COPD Reaches Primary Completion

A Phase 3 clinical trial investigating itepekimab (SAR440340) for chronic obstructive pulmonary disease (COPD) reached its primary completion on 2025-04-11. The study, identified as NCT04701983, enrolled 1127 participants to assess the drug's efficacy, safety, and tolerability.

Background

Itepekimab (SAR440340) is an investigational drug being evaluated for the treatment of Chronic Obstructive Pulmonary Disease (COPD). This condition is a progressive lung disease that causes obstructed airflow from the lungs. The completion of this Phase 3 study marks a significant step in understanding the potential role of itepekimab in managing COPD.

Trial design

The study, titled "Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)" (NCT04701983), was a Phase 3 trial. It enrolled a total of 1127 participants diagnosed with Chronic Obstructive Pulmonary Disease. The interventions included itepekimab (SAR440340) and placebo. The primary objective was to evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD. Secondary objectives included evaluating the efficacy of itepekimab compared with placebo on pulmonary function, occurrence of acute exacerbation of COPD (AECOPD), and severe AECOPD in former smokers.

What this means

The primary completion of the Phase 3 trial for itepekimab in COPD signifies that the collection of data for the primary outcome measure has concluded. Researchers will now proceed with analyzing the extensive data gathered from 1127 participants. The results of this analysis will be crucial in determining whether itepekimab demonstrates a clinically meaningful benefit in reducing COPD exacerbations and improving pulmonary function, potentially offering a new therapeutic option for patients with this chronic respiratory condition.

Source

The information regarding the primary completion of this clinical trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT04701983, titled "Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)," was updated on 2025-04-11 on clinicaltrials.gov.