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

ConditionEosinophilic Esophagitis (EoE)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorRegeneron Pharmaceuticals

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial 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)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

350 Participants
are divided into 1 treatment group
Group A: EoE Patients treated with DUPIXENT®1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Sanofi

Collaborator

Source ClinicalTrials.gov
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