A U.S. Registry of Eosinophilic Esophagitis Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care (EDESIA)

Regeneron Pharmaceuticals

Status: Enrolling

Conditions: Eosinophilic Esophagitis (EoE)

Treatments: Drug: dupilumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06693531

R668-EE-2328

Details and patient eligibility

About

This observational research study is to better understand patients with eosinophilic esophagitis (EoE) who have recently been prescribed DUPIXENT® (dupilumab). The purpose of this research study is to look at how DUPIXENT is used in normal care of patients with EoE.

Possible benefits to others include a better understanding of EoE and helping to inform research and clinical trial design leading to treatment decisions in this patient population going forward.

Patient questionnaires will measure the following:

• How EoE makes one feel
• EoE symptoms
• How EoE affects quality-of-life
• How EoE impacts aspects of daily life
• How difficult it is to swallow
• How EoE symptoms have changed throughout the study

Enrollment: 300 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Initiating treatment with DUPIXENT® for EoE according to the USPI
2. Able to understand and complete registry-related questionnaires (including adolescents)

Key Exclusion Criteria:

1. Patients who have a contraindication to DUPIXENT® according to the USPI
2. Treatment with DUPIXENT® within the 6 months prior to the screening assessment
3. Participation in an ongoing interventional study on or within 6 months of the baseline assessment. Once enrolled in registry, participation is allowed in other ongoing studies (at the discretion of the registry investigator)

NOTE: Other protocol defined inclusion/exclusion criteria apply

Trial design

300 participants in 1 patient group

EoE Patients treated with DUPIXENT®

Treatment:

Drug: dupilumab