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 (ProMEAL)

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

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 Overview

• Status: Recruiting
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Drug: Dupilumab

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Trial Transparency email recommended (Toll free for US & Canada); Phone Number: option 6 800-633-1610; Email: contact-us@sanofi.com

Study Locations

• Germany
  • Bavaria
    • Dachau, Bavaria, Germany, 85221
      • Recruiting
      • Investigational Site Number: 0000001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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 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

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 patients' 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)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dupilumab arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Descriptive statistical analysis of medical history characteristics	At baseline
Descriptive statistical analysis of socio-demographic characteristics	At baseline
Descriptive statistical analysis of disease characteristics	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolut change from baseline in endoscopic reference score (EREFS)	Absolut change from baseline in EREFS (including inflammatory and fibrostenotic subscore)	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		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	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)	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)	After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Absolute change from baseline in Hospital Anxiety and Depression Scale (HADS)		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)		After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Absolute change from baseline Pediatric Quality of Life Inventory (PEDS-QL)		After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Number of hospitalizations due to EoE		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		During the last 12 months before baseline and after 12 and 24 months of dupilumab treatment
Reason(s) for initiation of dupilumab treatment		At baseline
Descriptive statistical analysis of details on dupilumab treatment	Descriptive analysis: form of administration, location of administration	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	Throughout the study, for approximately 24 months after initiation of dupilumab treatment

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): May 29, 2029

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Digestive System Diseases; Gastrointestinal Diseases; Hypersensitivity, Immediate; Hypersensitivity; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Esophageal Diseases; Gastroenteritis; Esophagitis; Hemic and Lymphatic Diseases; Eosinophilic Esophagitis; dupilumab
• Other Study ID Numbers: OBS18402; U1111-1306-7545 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No