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

August 11, 2026 updated by: Regeneron Pharmaceuticals

A U.S. Registry of Eosinophilic Esophagitis Patients Treated With DUPIXENT® As Standard of Care

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

368

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Childrens Hospital
      • Sun City, Arizona, United States, 85351
        • Arizona Digestive Health/GI Alliance
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Childrens Hospital
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • Los Angeles, California, United States, 90033
        • University of Southern California Keck School of Medicine
      • Los Angeles, California, United States, 90024
        • University of California Los Angeles (UCLA)
      • Oakland, California, United States, 94609
        • University of California, San Francisco
      • Palo Alto, California, United States, 94304
        • Stanford University
      • San Francisco, California, United States, 94115
        • University of California San Francisco (UCSF)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
      • Aurora, Colorado, United States, 80045
        • Childrens Hospital Colorado
      • Littleton, Colorado, United States, 80120
        • Rocky Mountain Gastroenterology
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • UConn Health - The Carole and Ray Neag Comprehensive Cancer Center
      • New Haven, Connecticut, United States, 06510
        • Yale School of Medicine
    • Florida
      • Orange City, Florida, United States, 32763
        • Gastroenterology of Greater Orlando
      • Orlando, Florida, United States, 32806
        • Orlando Health
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Healthcare, Emory Clinic
      • Atlanta, Georgia, United States, 30342
        • GI Care for Kids LLC
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern University, Feinberg School of Medicine
      • Libertyville, Illinois, United States, 60048
        • Comprehensive Gastrointestinal Health, LLC
      • Skokie, Illinois, United States, 60077
        • Endeavor Health, Skokie Campus
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Kansas Gastroenterology LLC
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Allergy & Asthma Specialists, P.S.C.
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Boston Childrens Hospital
      • Boston, Massachusetts, United States, 02111
        • Boston Specialists, Chinatown Office
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • GI Associates and Endoscopy Center
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Kansas City VA Medical Center
      • St Louis, Missouri, United States, 63110
        • Washington University in Saint Louis
    • New Jersey
      • Ocean City, New Jersey, United States, 07712
        • Allergy Partners of N.J., P.C.
    • New York
      • Lake Success, New York, United States, 11042
        • Steven And Alexandra Cohen Children's Medical Center Of New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10021
        • Weil Cornell Medicine NYP
      • Rochester, New York, United States, 14618
        • Gastroenterology Group of Rochester LLP
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Winston-Salem, North Carolina, United States, 27157
        • Atrium Health / Wake Forest University School of Medicine
    • Ohio
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology Research, LLC
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Susquehanna Research Group
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Summerville, South Carolina, United States, 29486
        • Palmetto Gastroenterology Clinical Research
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Southlake, Texas, United States, 76092
        • GI Alliance
    • Utah
      • Layton, Utah, United States, 84041
        • Tanner Clinic
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Home Health Company
      • Tacoma, Washington, United States, 98405
        • Washington Gastroenterology, GIA
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The target population comprises of patients (≥1 years old) who are initiating treatment with DUPIXENT® for EoE according to the United States Prescribing Information (USPI)

Description

Key Inclusion Criteria:

  1. Initiating treatment with DUPIXENT® for EoE according to the USPI
  2. 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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EoE Patients treated with DUPIXENT®
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.
Other Names:
  • REGN668
  • SAR231893
  • DUPIXENT®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Demographic characteristic of participants who receive dupilumab for EoE: Age
Time Frame: Baseline and up to 3 years after treatment initiation
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
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
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
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
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
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
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
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
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
Previous 3 months and up to 3 years after treatment initiation
Prior dupilumab exposure history of participant
Time Frame: Baseline and up to 3 years after treatment initiation
Baseline and up to 3 years after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2024

Primary Completion (Estimated)

May 22, 2030

Study Completion (Estimated)

May 22, 2030

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Actual)

November 18, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2026

Last Update Submitted That Met QC Criteria

August 11, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R668-EE-2328

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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