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

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: Recruiting
• Conditions: Eosinophilic Esophagitis (EoE)
• Intervention / Treatment: Drug: dupilumab

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Clinical Trials Administrator; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Recruiting
      • Phoenix Childrens Hospital
    • Sun City, Arizona, United States, 85351
      • Active, not recruiting
      • Arizona Digestive Health/GI Alliance
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Recruiting
      • Arkansas Childrens Hospital
  • California
    • La Jolla, California, United States, 92037
      • Active, not recruiting
      • Scripps Clinic
    • Los Angeles, California, United States, 90033
      • Active, not recruiting
      • University of Southern California Keck School of Medicine
    • Los Angeles, California, United States, 90024
      • Active, not recruiting
      • University of California Los Angeles (UCLA)
    • Oakland, California, United States, 94609
      • Recruiting
      • University of California, San Francisco
    • San Francisco, California, United States, 94115
      • Active, not recruiting
      • University of California San Francisco (UCSF)
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Childrens Hospital Colorado
    • Aurora, Colorado, United States, 80045
      • Active, not recruiting
      • University of Colorado Anschutz Medical Campus
    • Littleton, Colorado, United States, 80120
      • Active, not recruiting
      • Rocky Mountain Gastroenterology
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Active, not recruiting
      • UConn Health - The Carole and Ray Neag Comprehensive Cancer Center
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale School of Medicine
  • Florida
    • Orange City, Florida, United States, 32763
      • Recruiting
      • Gastroenterology of Greater Orlando
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Orlando Health
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • GI Care for Kids LLC
    • Atlanta, Georgia, United States, 30322
      • Active, not recruiting
      • Emory Healthcare, Emory Clinic
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Chicago, Illinois, United States, 60611
      • Active, not recruiting
      • Northwestern University, Feinberg School of Medicine
    • Libertyville, Illinois, United States, 60048
      • Active, not recruiting
      • Comprehensive Gastrointestinal Health, LLC
    • Skokie, Illinois, United States, 60077
      • Recruiting
      • Endeavor Health, Skokie Campus
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Active, not recruiting
      • Kansas Gastroenterology LLC
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Recruiting
      • Allergy & Asthma Specialists, P.S.C.
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Childrens Hospital
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Boston Specialists, Chinatown Office
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Active, not recruiting
      • Mayo Clinic
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Active, not recruiting
      • GI Associates and Endoscopy Center
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • Active, not recruiting
      • Kansas City VA Medical Center
    • St Louis, Missouri, United States, 63110
      • Active, not recruiting
      • Washington University in Saint Louis
  • New Jersey
    • Ocean City, New Jersey, United States, 07712
      • Active, not recruiting
      • Allergy Partners of N.J., P.C.
  • New York
    • Lake Success, New York, United States, 11042
      • Recruiting
      • Steven And Alexandra Cohen Children's Medical Center Of New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10021
      • Recruiting
      • Weil Cornell Medicine NYP
    • Rochester, New York, United States, 14618
      • Recruiting
      • Gastroenterology Group of Rochester LLP
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill
    • Durham, North Carolina, United States, 27710
      • Active, not recruiting
      • Duke University
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Atrium Health / Wake Forest University School of Medicine
  • Ohio
    • Mentor, Ohio, United States, 44060
      • Active, not recruiting
      • Great Lakes Gastroenterology Research, LLC
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Active, not recruiting
      • Susquehanna Research Group
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • The Children's Hospital of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19104
      • Active, not recruiting
      • University of Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
    • Summerville, South Carolina, United States, 29486
      • Active, not recruiting
      • Palmetto Gastroenterology Clinical Research
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Active, not recruiting
      • Brooke Army Medical Center
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
    • Southlake, Texas, United States, 76092
      • Active, not recruiting
      • GI Alliance
  • Utah
    • Layton, Utah, United States, 84041
      • Recruiting
      • Tanner Clinic
    • Salt Lake City, Utah, United States, 84132
      • Withdrawn
      • University of Utah
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's Home Health Company
    • Tacoma, Washington, United States, 98405
      • Active, not recruiting
      • Washington Gastroenterology, GIA
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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	Baseline and up to 3 years after treatment initiation
Demographic characteristic of participants who receive dupilumab for EoE: Race	Baseline and up to 3 years after treatment initiation
Demographic characteristic of participants who receive dupilumab for EoE: Weight	Baseline and up to 3 years after treatment initiation
Demographic characteristic of participants who receive dupilumab for EoE: Height	Baseline and up to 3 years after treatment initiation
Disease characteristics of participants who receive dupilumab for EoE: Esophagogastroduodenoscopy (EGD)	Baseline and up to 3 years after treatment initiation
Disease characteristics of participants who receive dupilumab for EoE: Dilation/impaction history	Baseline and up to 3 years after treatment initiation
Disease characteristics of participants who receive dupilumab for EoE: Dietary interventions	Baseline and up to 3 years after treatment initiation
Disease characteristics of participants who receive dupilumab for EoE: Medical history	Baseline and up to 3 years after treatment initiation
EoE medication history of participant	Previous 1 year and up to 3 years after treatment initiation
Non-EoE medication history of participant	Previous 3 months and up to 3 years after treatment initiation
Prior dupilumab exposure history of participant	Baseline and up to 3 years after treatment initiation

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

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): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Digestive System Diseases; Gastrointestinal Diseases; Hypersensitivity, Immediate; Hypersensitivity; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Esophageal Diseases; Gastroenteritis; Esophagitis; Hemic and Lymphatic Diseases; Eosinophilic Esophagitis; dupilumab
• 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