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)

Sanofi

Status

Enrolling

Conditions

Eosinophilic Esophagitis

Treatments

Drug: Dupilumab

Study type

Observational

Funder types

Industry

Identifiers

NCT06695897

U1111-1306-7545 (Registry Identifier)

OBS18402

Details and patient eligibility

About

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.

Full description

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

Enrollment

150 estimated patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

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)