RecruitingPhase 3NCT07793409

A Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD)

An Extension Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig, Including Inhaled Corticosteroid Withdrawal, in Adults With Chronic Obstructive Pulmonary Disease (COPD) Who Completed Studies EFC18243 or EFC18244


Sponsor

Sanofi

Enrollment

1,508 participants

Start Date

Sep 16, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, Phase 3, long-term safety extension study including participants of previous lunsekimig clinical trials with inadequately controlled chronic obstructive pulmonary disease (COPD ) characterized by an eosinophilic phenotype. The purpose of the LTS 18211 study is to characterize the long-term safety and efficacy of lunsekimig in adults with COPD who completed studies EFC18243 or EFC18244 in the main study, and to assess the impact of inhaled corticosteroids (ICS ) withdrawal in the ICS withdrawal sub-study. The study duration will be up to 100 weeks, including the following components: * Baseline Visit (Visit 1 / Week 0) will coincide with the End-of-Intervention visit from the parent study (EFC18243 or EFC18244) if possible * Treatment duration of up to 96 weeks * Safety follow-up period of approximately 4 weeks * The number of visits will be 26


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Lunsekimig for people with chronic obstructive pulmonary disease. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLunsekimig

* Pharmaceutical form: Solution for injection in prefilled syringe * Route of administration: Subcutaneous injection


Locations(3)

Newport Native MD- Site Number : 8403003

Newport Beach, California, United States

Helix Biomedics- Site Number : 8403065

Boynton Beach, Florida, United States

Investigational Site Number : 8264017

Rotherham, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07793409


Related Trials