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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study duration for each participant is planned to be 2 years. Total study duration is approximately 4 years.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DRUG	Dupilumab	This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Timeline

• Start date: 2024-12-02
• Primary completion: 2027-06-01
• Completion: 2029-05-29
• First posted: 2024-11-19
• Last updated: 2026-03-06

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study