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 range1 Year

SexALL

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)

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

Disease characteristics of participants who receive dupilumab for EoE: Dietary interventions

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 range1 Year

SexALL

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)