RecruitingNCT06695897

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

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


Sponsor

Sanofi

Enrollment

150 participants

Start Date

May 28, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dupilumab for people with eosinophilic esophagitis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDupilumab

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

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NCT06695897


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