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

Study on the use of investigational medication for eosinophilic esophagitis

Recruiting
12 years or above
All
Phase N/A
150 participants needed
1 Location

Study Overview

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.

Study Details

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

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Eosinophilic Esophagitis
  • Age: 12 years or above
  • Gender: All

Inclusion Criteria:

  • Patients diagnosed with EoE who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy
  • Patients for whom the treating physician has decided to initiate new treatment with dupilumab for EoE according to EU-SmPC independently from entry in study or for whom treatment with dupilumab for EoE according to EU-SmPC has been started within the last 7 days. The decision to initiate dupilumab treatment is made by the treating physician and the patient according to the patient´s medical need and to the standard of best medical practice. This decision is made independently and before inclusion in this NIS.
  • ≥ 12 years of age at baseline visit
  • ≥ 40 kg bodyweight
  • Voluntary study participation and signed written informed consent by patient and parent(s)/guardian(s), if applicable

Exclusion Criteria:

  • Patients who have a contraindication to dupilumab according to the current EU-SmPC.
  • Patients who have been treated with dupilumab for more than 7 days
  • Any acute or chronic condition that, in the treating physician´s opinion, would limit the patient´s ability to complete questionnaires or to participate in this study or impact the interpretation of the results.
  • Participation in an ongoing interventional or observational study that might, in the treating physician´s opinion, influence the assessments for the current study (parallel inclusion in another Sanofi-independent registry might be possible if the patient gives consent)

Updated on 09 May 2025. Study ID: NCT06695897

This study investigates the use of an investigational medication for treating eosinophilic esophagitis (EoE). EoE is a condition where a type of white blood cell called eosinophil builds up in the esophagus, which can lead to inflammation and difficulty swallowing. The purpose of this study is to observe how patients with EoE respond to the investigational medication in a real-world setting in Germany, focusing on their medical history, other health conditions, and previous treatments for EoE.

Participants in the study will have their health-related quality of life assessed over a period of two years. The study will collect information on how the investigational medication is used in everyday life and its long-term safety and effectiveness as reported by both doctors and patients.

  • Who can participate: Individuals aged 12 years and older with eosinophilic esophagitis who weigh at least 40 kg and are not adequately managed by standard treatments can participate. Participants must not have been on the investigational medication for more than 7 days.
  • Study details: Participants will take part in an observational study where they will report their experiences with the investigational medication. They will also complete questionnaires about their health and quality of life.
  • Study timelines: The study will last 2 years.

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