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

Study acronym: COLOSSUS
StatusRecruiting
PhasePhase 3
SponsorSanofi
Started

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Record History

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  1. Recruitment opened Show 4 more changesShow less
    • Trial sites expanded: 0 → 3 locations
    • Start date changed from estimate of Sep 14, 2026 to Sep 16, 2026
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 2 of 6 entries
  2. Primary and study completion moved earlier from Oct 28, 2031 to Jul 23, 2031v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
285 trials monitored
See 12 trials at risk
COPD
1,120 trials monitored
See 36 trials at risk
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
Trial Details
NCT Number NCT07793409
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Chronic Obstructive Pulmonary Disease
Related terms Pulmonary Disease, Chronic Obstructive
Enrollment 1,508 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov