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A Non-interventional Observational Study to Assess Long-term Efficacy and Safety of Dupilumab for the Treatment of Patients (>= 12 Years) With Eosinophilic Esophagitis Under Real-world-conditions in Germany

Study acronym: ProMEAL
StatusRecruiting
PhaseNot specified
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date: Dec 2, 2024 to May 28, 2025
    • Trial sites expanded: 1 → 15 locations
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 1 of 13 entries
  2. Eligibility criteria expanded, about 20 wordsv4
  3. Primary completion date: Dec 10, 2026 to Jun 1, 2027
    • Study completion date: Nov 15, 2028 to May 29, 2029
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Nov 15, 2024 to Dec 10, 2026
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 15, 2024 to Dec 2, 2024
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 longitudinal, observational non-interventional study (NIS) designed to characterize the patient population who receives dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany with respect to their medical history, socio-demographic and disease characteristics, comorbidities (including type 2 inflammatory and atopic conditions), concomitant therapies and prior EoE treatments. Furthermore, this NIS aims to describe the long-term effectiveness of dupilumab for the treatment of EoE as assessed by the treating physician and reported by the patient, and its effect on health-related quality of life (HRQoL) during an individual observational period of two years. In addition, data on real-world use patterns and long-term safety data of dupilumab treatment for EoE will be collected.
Trial Details
NCT Number NCT06695897
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Eosinophilic Esophagitis
Related terms Eosinophilic Esophagitis
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov