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NCT Number: NCT06693531

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Eosinophilic Esophagitis (EoE) Digestive System Diseases Eosinophilia Eosinophilic Esophagitis Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Phoenix Childrens Hospital, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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

Key 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)

NOTE: Other protocol defined inclusion/exclusion criteria apply

Treatment and study plan

Dupilumab

Drug

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: DUPIXENT®, REGN668, SAR231893

Primary outcomes

  1. Demographic characteristic of participants who receive dupilumab for EoE: Age

    Time frame: Baseline and up to 3 years after treatment initiation

  2. Demographic characteristic of participants who receive dupilumab for EoE: Race

    Time frame: Baseline and up to 3 years after treatment initiation

  3. Demographic characteristic of participants who receive dupilumab for EoE: Weight

    Time frame: Baseline and up to 3 years after treatment initiation

  4. Demographic characteristic of participants who receive dupilumab for EoE: Height

    Time frame: Baseline and up to 3 years after treatment initiation

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

    Time frame: Baseline and up to 3 years after treatment initiation

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

    Time frame: Baseline and up to 3 years after treatment initiation

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

    Time frame: Baseline and up to 3 years after treatment initiation

  8. Disease characteristics of participants who receive dupilumab for EoE: Medical history

    Time frame: Baseline and up to 3 years after treatment initiation

  9. EoE medication history of participant

    Time frame: Previous 1 year and up to 3 years after treatment initiation

  10. Non-EoE medication history of participant

    Time frame: Previous 3 months and up to 3 years after treatment initiation

  11. Prior dupilumab exposure history of participant

    Time frame: Baseline and up to 3 years after treatment initiation

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study title

A U.S. Registry of Eosinophilic Esophagitis Patients Treated With DUPIXENT® As Standard of Care

Acronym: EDESIA

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Nov 18, 2024
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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