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A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

Study acronym: CEREN-1
StatusActive, Not Recruiting
PhasePhase 3
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting Enrollment increased: 210 → 231 participants · Primary completion moved earlier from Jan 8, 2027 to Oct 14, 2026 · Completion moved earlier from Dec 13, 2027 to Sep 16, 2027 · 1 morev23 Show 4 more changesShow less
    • Enrollment increased: 210 → 231 participants
    • Primary completion moved earlier from Jan 8, 2027 to Oct 14, 2026
    • Completion moved earlier from Dec 13, 2027 to Sep 16, 2027
    • Site details revised at 121 of 121 sites
  2. Study sites: 120 to 121v22
  3. Study sites: 121 to 120v21
  4. Trial sites expanded: 118 → 121 locationsv20
  5. Study sites: 115 to 118v19
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 114 to 115v18
  2. Study sites: 107 to 114v17
  3. Study sites: 105 to 107v16
  4. Study sites: 99 to 105v15
  5. Study sites: 96 to 99v14
  6. Study sites: 93 to 96v13
  7. Study sites: 83 to 93v12
  8. Study sites: 62 to 83v11
  9. Study sites: 49 to 62v10
  10. Study sites: 38 to 49v9
  11. Study sites: 23 to 38v8
  12. Study sites: 20 to 23v7
  13. Study sites: 14 to 20v6
  14. Eligibility criteria shortened, about 26 wordsv5 See this version in full on ClinicalTrials.gov ↗
  15. Study sites: 11 to 14v4
  16. Study sites: 4 to 11v3
  17. Study sites: 2 to 4v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
EFC18418 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo as add-on therapy to intranasal corticosteroids (INCS) in male and female participants with chronic rhinosinusitis with nasal polyps (CRSwNP) aged 18 years of age and older. Study details include: * The study duration per participant (4-week screening, 52-week treatment, 20-week safety follow-up) will be up to 76 weeks. For participants transitioning to the LTS18420 study, the study duration will be 56 weeks. * The treatment duration will be up to 52 weeks. * The number of visits will be 9 site visits and 20 phone/home visits.
Trial Details
NCT Number NCT06834347
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions Chronic Rhinosinusitis With Nasal Polyps
Enrollment 231 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov