An observational study in Eosinophilic Esophagitis, sponsored by Sanofi. Recruiting at 15 sites in Germany. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Sanofi · Observational
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 study duration for each participant is planned to be 2 years. Total study duration is approximately 4 years.
235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.
This study's planned enrollment of 150 is above the median of 88 across 85 observational studies indexed under Eosinophilic Esophagitis.
Browse Eosinophilic Esophagitis studies →Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients suffering from EoE, ≥ 12 years of age with at least 40 kg bodyweight who are planned to be initiated with dupilumab for the treatment of EoE according to the prescribing information, i.e., the current Summary of Product Characteristics approved in the European Union (EU-SmPC).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who receive dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany
Drug: Dupilumab
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Descriptive statistical analysis of medical history characteristics
Time frame: At baseline
Descriptive statistical analysis of socio-demographic characteristics
Time frame: At baseline
Descriptive statistical analysis of disease characteristics
Time frame: At baseline
Absolut change from baseline in endoscopic reference score (EREFS)
Absolut change from baseline in EREFS (including inflammatory and fibrostenotic subscore)
Time frame: After 3, 6 (optional), 12 and 24 months of dupilumab treatment
Proportion of patients with eosinophils per high power field (EOS/hpf) < 15 in esophageal biopsies
Time frame: After 3, 6 (optional), 12 and 24 months of dupilumab treatment
Change in clinical symptoms from baseline
Change in clinical symptoms (as assessed in clinical practice) from baseline
Time frame: From baseline until 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Behavioral changes regarding food intake from baseline
Behavioral changes regarding food intake (as reported by the patient)
Time frame: From baseline until 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Absolute change from baseline in Dysphagia Numerical Rating Scale (NRS)
Scale from 0 (no trouble to swallow) - 10 (maximum trouble to swallow)
Time frame: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Absolute change from baseline in Hospital Anxiety and Depression Scale (HADS)
Time frame: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Absolute change from baseline Pediatric Eosinophilic Esophagitis Symptom Scores (PEESS v2.0)
Time frame: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Absolute change from baseline Pediatric Quality of Life Inventory (PEDS-QL)
Time frame: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Number of hospitalizations due to EoE
Time frame: During the last 12 months before baseline and after 12 and 24 months of dupilumab treatment
Number of sick leave days at work due to EoE
Time frame: During the last 12 months before baseline and after 12 and 24 months of dupilumab treatment
Reason(s) for initiation of dupilumab treatment
Time frame: At baseline
Descriptive statistical analysis of details on dupilumab treatment
Descriptive analysis: form of administration, location of administration
Time frame: Throughout the study, for approximately 24 months after dupilumab treatment
Analysis of treatment emergent adverse events (TEAEs)
Quantity of treatment emergent adverse events, quantity of TEAE that lead to ending of therapy, collection of type of TEAE
Time frame: Throughout the study, for approximately 24 months after initiation of dupilumab treatment
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Jun 2027, 24 months after the start.
Of 55 observational studies under Eosinophilic Esophagitis, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 120. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
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