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

NCT06695897 | Recruiting DMC FDA Drug

• 2 other identifiers: OBS18402U1111-1306-7545
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• Absolut change from baseline in endoscopic reference score (EREFS)

  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

  From baseline until 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment

• Behavioral changes regarding food intake from baseline

  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)

  After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment

Study Arms (1)

Dupilumab arm

Patients who receive dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany

Drug: Dupilumab

Interventions

Dupilumab DRUG

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

Dupilumab arm

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patients diagnosed with EoE who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy
• ≥ 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

You may not qualify if:

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

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Investigational Site Number: 0000001

Dachau, Bavaria, 85221, Germany

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): May 29, 2029
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)