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: PERSEPHONE
StatusRecruiting
PhasePhase 3
SponsorSanofi
Started

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Record History

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  1. Trial sites expanded: 294 → 314 locations
  2. Trial sites expanded: 221 → 294 locations
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 3 of 15 entries
  3. Trial sites expanded: 217 → 221 locationsv14
  4. Study sites: 215 to 217v13
  5. Trial sites expanded: 196 → 215 locationsv12
  6. Trial sites expanded: 183 → 196 locationsv11
  7. Trial sites expanded: 166 → 183 locationsv10
  8. Trial sites expanded: 153 → 166 locationsv9
  9. Study sites: 135 to 153
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (15)
    • Primary endpoint revised
    v8
  10. Study sites: 100 to 135v7
  11. Study sites: 87 to 100
    • Eligibility criteria revised
    v6
  12. Study sites: 47 to 87v5
  13. Study sites: 20 to 47v4
  14. Study sites: 11 to 20v3
  15. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 11
    • Start date changed from estimate of Sep 18, 2025 to Sep 16, 2025
    v2
  16. 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 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.
Trial Details
NCT Number NCT07190209
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Chronic Obstructive Pulmonary Disease
Related terms Pulmonary Disease, Chronic Obstructive
Enrollment 942 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov