A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care
Study on Eosinophilic Esophagitis with Observational Approach
Study Overview
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 signs and/or symptoms, eg, how difficult it is to swallow
- How EoE affects quality-of-life
- How EoE impacts aspects of daily life
- How EoE symptoms have changed throughout the study
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Eosinophilic Esophagitis (EoE)
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Age: 1 year or above
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Gender: All
Key Inclusion Criteria:
- Initiating treatment with DUPIXENT® for EoE according to the USPI
- Participants aged ≥12 years and caregivers or legal guardians of participants aged <12 years must be able to understand and complete registry-related questionnaires
Key Exclusion Criteria:
- Patients who have a contraindication to DUPIXENT® according to the USPI
- Treatment with DUPIXENT® within the 6 months prior to the screening assessment
- 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
This study investigates eosinophilic esophagitis (EoE), focusing on the treatment of patients with an investigational medication in routine care. This observational study aims to understand how patients with EoE are treated with an investigational medication in routine care.
Participants will complete questionnaires to assess how EoE affects their feelings, symptoms such as swallowing difficulties, quality of life, daily life impacts, and changes in symptoms over time. An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment, which may focus on people using specific medications or having certain conditions to better understand how treatments work.
- Who can participate: Participants must be 12 years or older and starting treatment with DUPIXENT® for EoE, or caregivers of those under 12 who can complete questionnaires.
- Study details: Participants will complete questionnaires about their experiences with EoE, including symptoms and daily life impacts. This observational study will not alter their treatment.