A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: dupilumab.
- Who it may be relevant to
- Registry conditions: Eosinophilic Esophagitis (EoE). Basic parameters: from 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A U.S. Registry of Eosinophilic Esophagitis Patients Treated With DUPIXENT® As Standard of Care
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
Interventions
- Drug dupilumab
No investigational agents will be provided. Dupilumab will be prescribed as per usual clinical practice and will not be provided by the sponsor.
Primary outcome measures
- Demographic characteristic of participants who receive dupilumab for EoE: Age [Time frame: Baseline and up to 3 years after treatment initiation]
- Demographic characteristic of participants who receive dupilumab for EoE: Race [Time frame: Baseline and up to 3 years after treatment initiation]
- Demographic characteristic of participants who receive dupilumab for EoE: Weight [Time frame: Baseline and up to 3 years after treatment initiation]
- Demographic characteristic of participants who receive dupilumab for EoE: Height [Time frame: Baseline and up to 3 years after treatment initiation]
- Disease characteristics of participants who receive dupilumab for EoE: Esophagogastroduodenoscopy (EGD) [Time frame: Baseline and up to 3 years after treatment initiation]
- Disease characteristics of participants who receive dupilumab for EoE: Dilation/impaction history [Time frame: Baseline and up to 3 years after treatment initiation]
- Disease characteristics of participants who receive dupilumab for EoE: Dietary interventions [Time frame: Baseline and up to 3 years after treatment initiation]
- Disease characteristics of participants who receive dupilumab for EoE: Medical history [Time frame: Baseline and up to 3 years after treatment initiation]
- EoE medication history of participant [Time frame: Previous 1 year and up to 3 years after treatment initiation]
- Non-EoE medication history of participant [Time frame: Previous 3 months and up to 3 years after treatment initiation]
Eligibility criteria
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 55 centers
- Phoenix Childrens Hospital — Phoenix
- Arizona Digestive Health/GI Alliance — Sun City
- Arkansas Childrens Hospital — Little Rock
- Scripps Clinic — La Jolla
- University of California Los Angeles (UCLA) — Los Angeles
- University of Southern California Keck School of Medicine — Los Angeles
- University of California, San Francisco — Oakland
- Stanford University — Palo Alto
- … and 47 more centers
Publications
- Dellon ES, Chehade M, McGowan EC, Jensen ET, Leung J, Eren D, Angello JT, Radwan A, Durrani SR, deMarchi S. Baseline characteristics, treatment patterns, and long-term outcomes in patients with eosinophilic esophagitis initiating dupilumab in routine clinical practice: study protocol of a phase IV, prospective, observational, multicenter registry (EDESIA). Ther Adv Gastroenterol. 2026 Apr 28;19:17 PMID 42100495
Identifiers
NCT: NCT06693531 · R668-EE-2328