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A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial)

StatusActive, Not Recruiting
PhasePhase 4
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 12 words
    • Secondary endpoints: 12 to 13
    • Publications: details revised at 1 of 1 entry
  2. Enrollment target: estimated 64 to confirmed 69
    • Primary completion date changed from estimate of Nov 11, 2025 to Nov 5, 2025
    v17
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 9, 2025 to Nov 11, 2025
    • Study completion date: Dec 2, 2027 to Feb 1, 2028
    • Site details revised at 30 of 30 sites
    v16
  4. Site details revised at 2 of 30 sitesv15
  5. Study sites revised (30)v14
Show 12 earlier versionsHide 12 earlier versions
  1. Study sites: 28 to 30v13
  2. Study sites: 25 to 28v12
  3. Study sites: 21 to 25v11
  4. Re-verified, no change to tracked fieldsv10
  5. Study sites: 18 to 21v9
  6. Study sites: 16 to 18v8
  7. Study sites: 15 to 16v7
  8. Study sites: 14 to 15v6
  9. Study sites: 8 to 14v5
  10. Study sites: 7 to 8v4
  11. Study sites: 5 to 7v3
  12. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 5
    • Primary completion date: Jul 28, 2025 to Dec 9, 2025
    • Study completion date: Nov 11, 2027 to Dec 2, 2027
    • Start date changed from estimate of Oct 20, 2023 to Nov 29, 2023
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
This is parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5 years) to evaluate the effect of dupilumab treatment on esophageal function, and remodeling in adults with eosinophilic esophagitis. Duration of study period (per participant) * Screening period: Up to 12 weeks before Week 0 * Randomized double-blind period: 24 weeks * Open label period: 104 weeks * Post Investigational Medicinal Product (IMP) intervention follow-up period: up to 12 weeks or until the participants switch to commercialized dupilumab, whatever comes first. There will be ten (10) site visits, and five (5) direct-to-participant IMP delivery visits (except if prohibited by local regulatory authorities or if participant is not willing. In this case, IMP will be dispensed at the study site).
Trial Details
NCT Number NCT06101095
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Eosinophilic Oesophagitis
Related terms Eosinophilic Esophagitis
Enrollment 69 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov