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-2
StatusActive, Not Recruiting
PhasePhase 3
SponsorSanofi
Started

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Record History

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  1. Primary completion date changed from estimate of Nov 6, 2026 to Sep 24, 2026 Show 4 more changesShow less
    • Study completion moved earlier from Oct 11, 2027 to Feb 17, 2027
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 8 of 22 entries
    • Site details revised at 2 of 111 sites
  2. Trial status changed: Recruiting → Active, Not Recruitingv19 Show 4 more changesShow less
    • Primary completion moved earlier from Jan 8, 2027 to Nov 6, 2026
    • Study completion moved earlier from Dec 13, 2027 to Oct 11, 2027
    • Enrollment target: estimated 210 to confirmed 216
    • Study sites: 112 to 111
  3. Study sites: 113 to 112v18
  4. Trial sites expanded: 108 → 113 locationsv17
  5. Trial sites expanded: 105 → 108 locationsv16
Show 14 earlier versionsHide 14 earlier versions
  1. Study sites: 103 to 105v15
  2. Study sites: 102 to 103v14
  3. Study sites: 100 to 102v13
  4. Study sites: 95 to 100v12
  5. Study sites: 69 to 95v11
  6. Study sites: 54 to 69v10
  7. Study sites: 44 to 54v9
  8. Study sites: 28 to 44v8
  9. Study sites: 22 to 28v7
  10. Study sites: 15 to 22v6
  11. Study sites: 13 to 15
    • Eligibility criteria shortened, about 26 words
    v5
  12. Study sites: 8 to 13v4
  13. Study sites: 7 to 8v3
  14. Study sites: 2 to 7v2
  1. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
286 trials monitored
See 13 trials at risk
EFC18419 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 NCT06834360
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Chronic Rhinosinusitis With Nasal Polyps
Enrollment 216 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov