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
Study ID
NCT06695897
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 2, 2024
Status verified
Mar 2026
Primary completion
Jun 1, 2027
Completion
May 29, 2029

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Dupilumab arm
    Patients who receive dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany

Primary Outcome Measure

Descriptive statistical analysis of medical history characteristics [ Time Frame: At baseline ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

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