Itepekimab Completes Phase 3 Long-Term COPD Safety Study

ClinicalTrials.gov recorded primary completion on September 10, 2026, for a completed Phase 3 study of itepekimab (SAR440340) in participants with chronic obstructive pulmonary disease, or COPD. The parallel, double-blind study enrolled 669 participants and evaluated long-term safety and tolerability, treatment-response durability, pharmacokinetics, and immunogenicity.

Background

The study investigated itepekimab in participants with COPD who had completed the treatment period of the parent clinical studies EFC16750 or EFC16819. The record describes the trial as an additional assessment of long-term safety and tolerability, with a secondary purpose of providing efficacy outcomes beyond the treatment period of those parent trials. The supplied data do not provide information about itepekimab’s mechanism, prior approvals, dosing rationale, or COPD prevalence.

Trial design

This Phase 3 trial, identified as NCT06208306, was completed after enrolling 669 participants with COPD. It used a parallel, double-blind, two-arm design. The listed interventions were itepekimab and placebo. The study was designed to evaluate participants receiving itepekimab subcutaneously every two weeks or every four weeks after they completed treatment in one of the parent studies.

The primary purpose was to assess safety and tolerability. Additional objectives included evaluating the durability of treatment response and providing pharmacokinetic and immunogenicity assessments. The record also described efficacy outcomes beyond the treatment period of the parent trials.

What this means

The study reached primary completion with a completed status in the ClinicalTrials.gov record. Its design focused on longer-term follow-up in participants who had already completed treatment in related studies, rather than providing a new efficacy comparison in the supplied data. Although placebo was listed as an intervention, the record provided no outcome measurements, primary-endpoint values, statistical analyses, confidence intervals, or adverse-event summary.

As a result, the supplied record supports conclusions about the study’s completion, size, COPD population, design, and planned safety and follow-up objectives. It does not support a numerical assessment of itepekimab’s efficacy, comparative safety, pharmacokinetics, or immunogenicity.

Source

Source: ClinicalTrials.gov, registry record for the completed Phase 3 study “A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD,” dated September 10, 2026. Available at clinicaltrials.gov/study/NCT06208306.