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Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma

Study acronym: AIRPHRODITE
StatusEnrolling by Invitation
PhasePhase 2
SponsorSanofi
Started
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Record History

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  1. Minor Trial sites expanded: 127 → 150 locations
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 7 entries
  2. Minor Study Status, Arms and Interventions, Referencesv24
  3. Minor Trial sites expanded: 122 → 127 locationsv23
  4. Notable Primary endpoint(s) modifiedv22 Show 7 more changesShow less
    • Trial status changed: Recruiting → Enrolling by Invitation
    • Trial sites expanded: 118 → 122 locations
    • Eligibility criteria shortened, about 35 words
    • Secondary endpoints: 12 to 7
    • Site details revised at 122 of 122 sites
    • Study title revised
    • Study description shortened, about 3 words
  5. Minor Study sites: 118 to 122v21
  6. Minor Trial sites expanded: 114 → 118 locations
    • Eligibility criteria expanded, about 20 words
    v20
  7. Minor Study sites: 112 to 114v19
  8. Minor Study sites: 109 to 112v18
  9. Minor Study sites: 103 to 109v17
  10. Minor Study sites: 101 to 103v16
  11. Minor Study sites: 100 to 101v15
  12. Minor Study sites: 91 to 100v14
  13. Notable Enrollment target: 530 to 900
    • Study sites: 84 to 91
    • Eligibility criteria expanded, about 5 words
    • Study title shortened, about 1 word
    v13
  14. Minor Study sites: 68 to 84v12
  15. Minor Study sites: 66 to 68v11
  16. Minor Study sites: 35 to 66v10
  17. Minor Study sites: 27 to 35v9
  18. Minor Enrollment target: 467 to 530
    • Study sites: 25 to 27
    • Secondary endpoints revised (12)
    • Eligibility criteria expanded, about 1 word
    v8
  19. Minor Study sites: 20 to 25v7
  20. Minor Study sites: 15 to 20v6
  21. Minor Study sites: 9 to 15v5
  22. Minor Study sites: 3 to 9v4
  23. Minor Study sites: 1 to 3v3
  24. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  25. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
284 trials monitored
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956 trials monitored
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This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with asthma who have previously completed the parent studies. After completion of the parent study, eligible participants will be offered the opportunity to participate in the long-term extension (LTE) study with lunsekimig. The study duration will be up to 148 weeks with a treatment duration being up to 144 weeks.
Trial Details
NCT Number NCT06609239
Lead Sponsor Sanofi
Conditions
(from sponsor)
Asthma
Related terms Asthma
Enrollment 900 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov