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RECRUITING
NCT06695897

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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