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An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps

Study acronym: CEREN-3
StatusActive, Not Recruiting
PhasePhase 3
SponsorSanofi
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 84% 380 → 59 participants
See other at-risk trials from Sanofi

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 23 → 46 locations
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 1 of 6 entries
  2. Enrollment reduced: 380 → 59 participants
    • Primary and study completion moved earlier from Dec 12, 2028 to Feb 17, 2027
    • Trial status changed: Enrolling by Invitation → Active, Not Recruiting
    v7
  3. Trial sites expanded: 15 → 23 locationsv6
  4. Trial sites expanded: 10 → 15 locationsv5
  5. Trial sites expanded: 4 → 10 locationsv4
  6. Trial sites expanded: 1 → 4 locationsv3
  7. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 1
    v2
  8. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
This is a double-blind, parallel-group, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments. The primary purpose of this study is to evaluate safety and tolerability of both new or continued treatment with itepekimab 300 mg SC high dose or itepekimab 300 mg SC low dose in participants with CRSwNP having completed the intervention period of the clinical studies EFC18418 or EFC18419. A secondary purpose of this study is to provide efficacy outcomes beyond the intervention period of the parent trials EFC18418 and EFC18419. Study details include: * The study duration will be up to 72 weeks. * The intervention duration will be 52 weeks. * A follow-up period of 20 weeks will be conducted. * The number of visits will be 8 and the number of phone contacts will be 4.
Trial Details
NCT Number NCT07424144
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Chronic Rhinosinusitis With Nasal Polyps
Enrollment 59 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov