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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
Sponsor: Sanofi
Summary
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.
Official title: Prospective, Non-interventional Observational Study to Characterize Dupilumab in the Long-term Management of Eosinophilic Esophagitis, Safety and Patient Reported Outcomes (Quality of Life) in Clinical Routine
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2025-05-28
Completion Date
2029-05-29
Last Updated
2026-09-17
Healthy Volunteers
Yes
Conditions
Interventions
Dupilumab
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Locations (15)
Investigational Site Number: 0000009
Aschaffenburg, Bavaria, Germany
Investigational Site Number: 0000014
Augsburg, Bavaria, Germany
Investigational Site Number: 0000001
Dachau, Bavaria, Germany
Investigational Site Number: 0000012
Erlangen, Bavaria, Germany
Investigational Site Number: 0000005
Giessen, Hesse, Germany
Investigational Site Number: 0000011
Wetzlar, Hesse, Germany
Investigational Site Number: 0000013
Osnabrück, Lower Saxony, Germany
Investigational Site Number: 0000002
Weyhe-Kirchweyhe, Lower Saxony, Germany
Investigational Site Number: 0000007
Bochum, North Rhine-Westphalia, Germany
Investigational Site Number: 0000003
Burbach, North Rhine-Westphalia, Germany
Investigational Site Number: 0000006
Guelders, North Rhine-Westphalia, Germany
Investigational Site Number: 0000010
Münster, North Rhine-Westphalia, Germany
Investigational Site Number: 0000008
Leipzig, Saxony, Germany
Investigational Site Number: 0000015
Magdeburg, Saxony-Anhalt, Germany
Investigational Site Number: 0000004
Berlin, Germany