RecruitingNot Applicable

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

United States350 participantsStarted 2024-11-22

Plain-language 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

Who can participate

Age range

1 Year

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Demographic characteristic of participants who receive dupilumab for EoE: Age

Timeframe: Baseline and up to 3 years after treatment initiation

Demographic characteristic of participants who receive dupilumab for EoE: Race

Timeframe: Baseline and up to 3 years after treatment initiation

Demographic characteristic of participants who receive dupilumab for EoE: Weight

Timeframe: Baseline and up to 3 years after treatment initiation

Demographic characteristic of participants who receive dupilumab for EoE: Height

Timeframe: Baseline and up to 3 years after treatment initiation

Disease characteristics of participants who receive dupilumab for EoE: Esophagogastroduodenoscopy (EGD)

Timeframe: Baseline and up to 3 years after treatment initiation

Disease characteristics of participants who receive dupilumab for EoE: Dilation/impaction history

Timeframe: Baseline and up to 3 years after treatment initiation

Trial details

NCT IDNCT06693531

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-05-22

Contact for this trial

Clinical Trials Administrator

844-734-6643 clinicaltrials@regeneron.com

View on ClinicalTrials.gov More Eosinophilic Esophagitis (EoE) trials

Plain-language summary

Who can participate

Age range

1 Year

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)