A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care
EDESIA
1 other identifier
observational
350
1 country
54
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
Longer than P75 for all trials
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2024
CompletedFirst Posted
Study publicly available on registry
November 18, 2024
CompletedStudy Start
First participant enrolled
November 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 22, 2030
April 22, 2026
April 1, 2026
5.5 years
October 30, 2024
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (11)
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
Study Arms (1)
EoE Patients treated with DUPIXENT®
Interventions
No investigational agents will be provided. Dupilumab will be prescribed as per usual clinical practice and will not be provided by the sponsor.
Eligibility Criteria
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)
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Sanoficollaborator
Study Sites (54)
Phoenix Childrens Hospital
Phoenix, Arizona, 85016, United States
Arizona Digestive Health/GI Alliance
Sun City, Arizona, 85351, United States
Arkansas Childrens Hospital
Little Rock, Arkansas, 72202, United States
Scripps Clinic
La Jolla, California, 92037, United States
University of California Los Angeles (UCLA)
Los Angeles, California, 90024, United States
University of Southern California Keck School of Medicine
Los Angeles, California, 90033, United States
University of California, San Francisco
Oakland, California, 94609, United States
University of California San Francisco (UCSF)
San Francisco, California, 94115, United States
Childrens Hospital Colorado
Aurora, Colorado, 80045, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Rocky Mountain Gastroenterology
Littleton, Colorado, 80120, United States
UConn Health - The Carole and Ray Neag Comprehensive Cancer Center
Farmington, Connecticut, 06030, United States
Yale School of Medicine
New Haven, Connecticut, 06510, United States
Gastroenterology of Greater Orlando
Orange City, Florida, 32763, United States
Orlando Health
Orlando, Florida, 32806, United States
Emory Healthcare, Emory Clinic
Atlanta, Georgia, 30322, United States
GI Care for Kids LLC
Atlanta, Georgia, 30342, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Comprehensive Gastrointestinal Health, LLC
Libertyville, Illinois, 60048, United States
Endeavor Health, Skokie Campus
Skokie, Illinois, 60077, United States
Kansas Gastroenterology LLC
Wichita, Kansas, 67226, United States
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, 42301, United States
Boston Specialists, Chinatown Office
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Childrens Hospital
Boston, Massachusetts, 02115, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
GI Associates and Endoscopy Center
Flowood, Mississippi, 39232, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
Washington University in Saint Louis
St Louis, Missouri, 63110, United States
Allergy Partners of N.J., P.C.
Ocean City, New Jersey, 07712, United States
Steven And Alexandra Cohen Children's Medical Center Of New York
Lake Success, New York, 11042, United States
Weil Cornell Medicine NYP
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Gastroenterology Group of Rochester LLP
Rochester, New York, 14618, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27710, United States
Atrium Health / Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
Susquehanna Research Group
Camp Hill, Pennsylvania, 17011, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Palmetto Gastroenterology Clinical Research
Summerville, South Carolina, 29486, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
GI Alliance
Southlake, Texas, 76092, United States
Tanner Clinic
Layton, Utah, 84041, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Seattle Children's Home Health Company
Seattle, Washington, 98105, United States
Washington Gastroenterology, GIA
Tacoma, Washington, 98405, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2024
First Posted
November 18, 2024
Study Start
November 22, 2024
Primary Completion (Estimated)
May 22, 2030
Study Completion (Estimated)
May 22, 2030
Last Updated
April 22, 2026
Record last verified: 2026-04