Eosinophilic Esophagitis (EoE)EDESIANCT06693531
A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care
An observational study of Eosinophilic Esophagitis (EoE), run by Regeneron Pharmaceuticals at 54 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Eosinophilic Esophagitis (EoE)
- What is being tested?
- dupilumab
- How many people
- 368 participants
- Where
- 54 sitesUnited States
- Study dates
- 22 Nov 2024to 22 May 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
United States54 sites
Emory Healthcare, Emory Clinic
Atlanta, Georgia, 30322
GI Care for Kids LLC
Atlanta, Georgia, 30342
Childrens Hospital Colorado
Aurora, Colorado, 80045
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Boston Specialists, Chinatown Office
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Childrens Hospital
Boston, Massachusetts, 02115
Susquehanna Research Group
Camp Hill, Pennsylvania, 17011
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22908
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611
Duke University
Durham, North Carolina, 27710
UConn Health - The Carole and Ray Neag Comprehensive Cancer Center
Farmington, Connecticut, 06030
GI Associates and Endoscopy Center
Flowood, Mississippi, 39232
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Baylor College of Medicine
Houston, Texas, 77030
Kansas City VA Medical Center
Kansas City, Missouri, 64128
Scripps Clinic
La Jolla, California, 92037
Steven And Alexandra Cohen Children's Medical Center Of New York
Lake Success, New York, 11042
Tanner Clinic
Layton, Utah, 84041
Comprehensive Gastrointestinal Health, LLC
Libertyville, Illinois, 60048
Arkansas Childrens Hospital
Little Rock, Arkansas, 72202
Rocky Mountain Gastroenterology
Littleton, Colorado, 80120
University of California Los Angeles (UCLA)
Los Angeles, California, 90024
University of Southern California Keck School of Medicine
Los Angeles, California, 90033
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale School of Medicine
New Haven, Connecticut, 06510
Weil Cornell Medicine NYP
New York, New York, 10021
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of California, San Francisco
Oakland, California, 94609
Allergy Partners of N.J., P.C.
Ocean City, New Jersey, 07712
Gastroenterology of Greater Orlando
Orange City, Florida, 32763
Orlando Health
Orlando, Florida, 32806
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, 42301
Stanford University
Palo Alto, California, 94304
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Mayo Clinic
Rochester, Minnesota, 55905
Gastroenterology Group of Rochester LLP
Rochester, New York, 14618
University of California San Francisco (UCSF)
San Francisco, California, 94115
Seattle Children's Home Health Company
Seattle, Washington, 98105
Endeavor Health, Skokie Campus
Skokie, Illinois, 60077
GI Alliance
Southlake, Texas, 76092
Washington University in Saint Louis
St Louis, Missouri, 63110
Palmetto Gastroenterology Clinical Research
Summerville, South Carolina, 29486
Arizona Digestive Health/GI Alliance
Sun City, Arizona, 85351
Washington Gastroenterology, GIA
Tacoma, Washington, 98405
Kansas Gastroenterology LLC
Wichita, Kansas, 67226
Atrium Health / Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read more
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
- Conditions
- Eosinophilic Esophagitis (EoE)
- Being tested
- dupilumab
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dupilumabDrug
Also called DUPIXENT®, REGN668, SAR231893
No investigational agents will be provided. Dupilumab will be prescribed as per usual clinical practice and will not be provided by the sponsor.
| Study group | Role | What they receive |
|---|---|---|
| EoE Patients treated with DUPIXENT® | Not described Receives: Drug: dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic characteristic of participants who receive dupilumab for EoE: Age
Measured: Baseline and up to 3 years after treatment initiation
Demographic characteristic of participants who receive dupilumab for EoE: Race
Measured: Baseline and up to 3 years after treatment initiation
Demographic characteristic of participants who receive dupilumab for EoE: Weight
Measured: Baseline and up to 3 years after treatment initiation
Demographic characteristic of participants who receive dupilumab for EoE: Height
Measured: Baseline and up to 3 years after treatment initiation
Disease characteristics of participants who receive dupilumab for EoE: Esophagogastroduodenoscopy (EGD)
Measured: Baseline and up to 3 years after treatment initiation
Disease characteristics of participants who receive dupilumab for EoE: Dilation/impaction history
Measured: Baseline and up to 3 years after treatment initiation
Disease characteristics of participants who receive dupilumab for EoE: Dietary interventions
Measured: Baseline and up to 3 years after treatment initiation
Disease characteristics of participants who receive dupilumab for EoE: Medical history
Measured: Baseline and up to 3 years after treatment initiation
EoE medication history of participant
Measured: Previous 1 year and up to 3 years after treatment initiation
Non-EoE medication history of participant
Measured: Previous 3 months and up to 3 years after treatment initiation
Prior dupilumab exposure history of participant
Measured: Baseline and up to 3 years after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start22 Nov 2024
- Primary completion22 May 2030 (estimated)
- Study completion22 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic Esophagitis (EoE)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 368 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693531
- Sponsor's protocol ID
- R668-EE-2328
- Acronym
- EDESIA
- Status last verified
- Aug 2026
- First submitted
- 30 Oct 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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;19:17562848261443887. doi: 10.1177/17562848261443887. eCollection 2026.
PubMed 42100495
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A U.S. Registry of Eosinophilic Esophagitis Patients Treated With DUPIXENT® As Standard of Care
- ClinicalTrials.gov ID
- NCT06693531
- Acronym / sponsor ID
- EDESIA / R668-EE-2328
- Conditions
- Eosinophilic Esophagitis (EoE)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 22 May 2030 (estimated)
- Study completion
- 22 May 2030 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EoE Patients treated with DUPIXENT® | – | Drug: dupilumab |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- 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 (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dupilumabAlso: DUPIXENT®, REGN668, SAR231893No investigational agents will be provided. Dupilumab will be prescribed as per usual clinical practice and will not be provided by the sponsor. | Drug | EoE Patients treated with DUPIXENT® |
Primary outcome
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
Prior dupilumab exposure history of participant
Time frame: Baseline and up to 3 years after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Derived from this study: PubMed 42100495Dellon 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;19:17562848261443887. doi: 10.1177/17562848261443887. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis (EoE), run by Regeneron Pharmaceuticals at 54 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic characteristic of participants who receive dupilumab for EoE: Age (time frame: Baseline and up to 3 years after treatment initiation). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06693531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.