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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
StatusRecruiting
PhasePhase 3
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 214 → 315 locations
  2. Study sites: 213 to 214 Eligibility criteria expanded, about 18 words · Secondary endpoints: details revised at 3 of 15 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 3 of 15 entries
  3. Trial sites expanded: 206 → 213 locationsv13
  4. Trial sites expanded: 194 → 206 locationsv12
  5. Trial sites expanded: 188 → 194 locationsv11
  6. Trial sites expanded: 175 → 188 locationsv10
  7. Study sites: 150 to 175 Eligibility criteria expanded, about 10 words · Secondary endpoints revised (15) · Primary endpoint revisedv9 Show 3 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (15)
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 117 to 150v8
  9. Study sites: 103 to 117 Eligibility criteria revisedv7 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites: 64 to 103v6
  11. Study sites: 42 to 64v5
  12. Study sites: 22 to 42v4
  13. Study sites: 13 to 22v3
  14. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 13 · Start date changed from estimate of Sep 18, 2025 to Sep 17, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 13
    • Start date changed from estimate of Sep 18, 2025 to Sep 17, 2025
  15. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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
284 trials monitored
See 12 trials at risk
COPD
1,068 trials monitored
See 31 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 NCT07190222
Lead Sponsor Sanofi
Conditions Chronic Obstructive Pulmonary Disease
Enrollment 942 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov