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Investigating the long-term safety of itepekimab for COPD patients

A Double-blinded Extension Study to Evaluate the Long-term Safety and Tolerability of Itepekimab in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Participated in Either EFC16750 or EFC16819 Clinical Studies

Phase 3 Interventional Sanofi · NCT06208306

This study is testing the long-term safety of a medication called itepekimab for people with COPD who have already taken part in related studies.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment700 (estimated)
Ages40 Years to 85 Years
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsitepekimab
Locations223 sites (Chandler, Arizona and 222 other locations)
Trial IDNCT06208306 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial is designed to evaluate the long-term safety and tolerability of itepekimab in patients with Chronic Obstructive Pulmonary Disease (COPD) who have previously participated in related studies. The study will involve a double-blind, parallel design with two treatment arms: one receiving itepekimab every two weeks and the other every four weeks. Participants will be monitored over a period of up to 72 weeks, which includes a treatment phase of up to 52 weeks followed by a 20-week follow-up. The study aims to gather additional safety data and assess treatment response durability beyond the initial treatment period.

Who should consider this trial

Good fit: Ideal candidates are COPD patients who have completed the treatment period of previous itepekimab studies EFC16750 or EFC16819.

Not a fit: Patients who have experienced malignancies or significant infections during prior studies may not benefit from this trial.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of itepekimab for COPD patients.

How similar studies have performed: Other studies involving itepekimab have shown promise, suggesting that this approach may yield beneficial results.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

- Patients with COPD who completed the treatment period in a previous itepekimab COPD Phase 3 clinical study (ie, EFC16750 or EFC16819) and for which an end-of-treatment (EOT) visit occurred no later than 3 days before the enrolment visit of this study.

Exclusion Criteria:

* Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin
* Any opportunistic infection during the parent study, such as tuberculosis (TB) or other infections whose nature or course may suggest an immunocompromised status
* Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study
* Any situation that led to a permanent premature IMP discontinuation in parent trials

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where this trial is running

Chandler, Arizona and 222 other locations

+173 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Obstructive Pulmonary Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.