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

Study acronym: COLOSSUS
StatusNot Yet Recruiting
PhasePhase 3
SponsorSanofi
Started2026-09-14
View on ClinicalTrials.gov ↗
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

Amendment history 2 changes detected by DataLookout

2026-09-05
minor
Primary completion moved earlier: 2031-10-28 → 2031-07-23
2026-09-05
minor
Completion moved earlier: 2031-10-28 → 2031-07-23
Trial Details
NCT Number NCT07793409
Lead Sponsor Sanofi
Conditions Chronic Obstructive Pulmonary Disease
Enrollment 1,508 participants
Start Date 2026-09-14
Primary Completion 2031-07-23 (estimated)
Study Completion 2031-07-23 (estimated)
Updated on ClinicalTrials.gov 2026-09-04