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Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis

NCT05247866 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-11-10

Study results available
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Summary

Eosinophilic Esophagitis (EoE) is a food driven non-immunoglobulin E (IgE) mediated disease involving eosinophils and type 2 inflammation. Current therapies include diet and the off label use of medications including proton pump inhibitors, topical steroids or biologics. Food elimination creates a decrease quality of life in many children. The goal of the study is to examine a T2 inhibitor (dupilumab) can allow successful reintroduction of allergic EoE foods into the diet. This is a single site study, enrolling subjects 6 to 25 years of age.

Conditions

  • Eosinophilic Esophagitis

Interventions

DIETARY_SUPPLEMENT

Eosinophilic Esophagitis (EoE) food introduction-1st

1 serving size of food proven to induce histologic and clinical symptoms in EoE

DIETARY_SUPPLEMENT

Eosinophilic Esophagitis (E0E) food introduction-2nd

Either 1 serving size of different food (not food in arm 1) to induce histologic and clinical symptoms in EoE or Increase the food in arm 1 to 2 serving size a day

DIETARY_SUPPLEMENT

Eosinophilic Esophagitis (EoE) Food introduction-3rd dose

Either 1 serving size of different food (not food in arm 1 or 2) to induce histologic and clinical symptoms in EoE or Increase the food in arm 2 to 2 serving size a day or unlimited amounts of food arm 1

DRUG

Dupilumab

All patients will receive open label dupilumab at the following doses \>12 years of age \> 40 kg 300 subcutaneous (SQ) weekly 6-11 years of age 5-15 kg 100 mg SQ every 2 weeks (Q2W) 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W

Sponsors & Collaborators

Principal Investigators

  • Jonathan Spergel, MD, PhD · Children's Hospital of Philadelphia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-16
Primary Completion
2025-01-21
Completion
2025-01-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05247866 on ClinicalTrials.gov