Clinical Trial

Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study

Study acronym: ENSEMBLE
Enrolling by Invitation Phase 2
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Summary
This is a single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately controlled CRSwNP who have completed a previous lunsekimig CRSwNP clinical study (also referred to as the parent study ACT18207). The study duration will be up to approximately 148 weeks per participant, including 144 weeks of treatment period and 4 weeks of follow-up.
Protocol Amendment History 4 changes
critical Primary endpoint(s) modified 2026-07-03
notable Enrollment increased: 64 -> 71 participants 2026-07-03
critical Trial status changed: RECRUITING → ENROLLING_BY_INVITATION 2026-05-21
notable Trial sites expanded: 20 -> 24 locations 2026-04-15
Trial Details
NCT Number NCT06914908
Lead Sponsor Sanofi
Conditions Chronic Rhinosinusitis With Nasal Polyps
Enrollment 71 participants
Start Date 2025-05-12
Primary Completion 2031-01-29 (estimated)
Study Completion 2031-01-29 (estimated)
Updated on ClinicalTrials.gov 2026-07-02