drugset / Trial / NCT07793409

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

NCT07793409 ↗

Phase 3 Recruiting 1508 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2026-09-16
Primary completion
2031-07-23
Completion
2031-07-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Lunsekimig Monoclonal antibody — Subcutaneous