Clinical Trial

Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype

Study acronym: THESEUS
Recruiting Phase 3
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Summary
This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: * Screening period of up to 4 weeks * Randomized intervention period of approximately 48 weeks * Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.
Protocol Amendment History 4 changes
notable Trial sites expanded: 206 -> 213 locations 2026-06-16
notable Trial sites expanded: 194 -> 206 locations 2026-05-28
notable Trial sites expanded: 188 -> 194 locations 2026-05-09
notable Trial sites expanded: 175 -> 188 locations 2026-04-22
Trial Details
NCT Number NCT07190222
Lead Sponsor Sanofi
Conditions Chronic Obstructive Pulmonary Disease
Enrollment 942 participants
Start Date 2025-09-17
Primary Completion 2029-11-27 (estimated)
Study Completion 2030-01-22 (estimated)
Updated on ClinicalTrials.gov 2026-06-15