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
Started

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Record History

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  1. Trial sites expanded: 82 → 85 locations
  2. Trial sites expanded: 68 → 82 locations
    • Eligibility criteria expanded, about 7 words
  3. Trial sites expanded: 61 → 68 locationsv13
  4. Trial sites expanded: 58 → 61 locations
    • Study completion moved earlier from Apr 4, 2029 to Feb 2, 2029
    v12
  5. Trial sites expanded: 53 → 58 locations
    • Study completion pushed from Feb 15, 2029 to Apr 4, 2029
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 48 to 53v10
  2. Study sites: 46 to 48v9
  3. Study sites: 33 to 46
    • Eligibility criteria expanded, about 20 words
    v8
  4. Study sites: 29 to 33v7
  5. Study sites: 20 to 29v6
  6. Study sites: 5 to 20v5
  7. Study sites: 6 to 5v4
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 6
    • Start date changed from estimate of Sep 15, 2025 to Sep 22, 2025
    v3
  9. Start date: Jul 8, 2025 to Sep 15, 2025
    • Primary completion date: Sep 15, 2028 to Dec 23, 2028
    • Study completion date: Dec 8, 2028 to Feb 15, 2029
    v2
  1. 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 35 trials at risk
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.
Trial Details
NCT Number NCT07053423
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Chronic Obstructive Pulmonary Disease
Related terms Pulmonary Disease, Chronic Obstructive
Enrollment 218 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov