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
Key facts
- Who runs it
- Sanofi
- Where
- Germany15 sites in 1 countryChoose a country to see its sites
- Trial code
- NCT06695897
- U1111-1306-7545
- Status
- Recruiting
- People taking part
- 150 people, planned
- Started
- 28 May 2025
- Expected to end
- 29 May 2029
- Type of study
- Observational
- Treatments tested
- Dupilumab
- Record updated
- 17 September 2026
Who can take part
- Age
- 12 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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 patients' 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
Who cannot take part
- 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 patients' ability to complete questionnaires or to participate in this study or impact the interpretation of the results
- Patients who have a contraindication to dupilumab according to the current EU-SmPC
- 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); The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- Dupilumab arm
Patients who receive dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany
Treatment: Dupilumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 17 September 2026