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A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.

Study acronym: AEOLUS
StatusRecruiting
PhasePhase 4
SponsorSanofi
Started2025-09-22
View on ClinicalTrials.gov ↗
LPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups. The purpose of this study is to assess the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive). Study details include: The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The number of visits will be 9.

Amendment history 5 changes detected by DataLookout

2026-06-13
minor
Trial sites expanded: 61 → 68 locations
2026-05-21
minor
Trial sites expanded: 58 → 61 locations
2026-05-21
minor
Completion moved earlier: 2029-04-04 → 2029-02-02
2026-04-24
minor
Trial sites expanded: 53 → 58 locations
2026-04-24
minor
Completion pushed: 2029-02-15 → 2029-04-04
Trial Details
NCT Number NCT07053423
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions Chronic Obstructive Pulmonary Disease
Enrollment 218 participants
Start Date 2025-09-22
Primary Completion 2028-12-23 (estimated)
Study Completion 2029-02-02 (estimated)
Updated on ClinicalTrials.gov 2026-06-12