Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT05247866
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Eosinophilic Esophagitis (EoE) food introduction-1st — DIETARY_SUPPLEMENT
    1 serving size of food proven to induce histologic and clinical symptoms in EoE
  • Eosinophilic Esophagitis (E0E) food introduction-2nd — DIETARY_SUPPLEMENT
    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
  • Eosinophilic Esophagitis (EoE) Food introduction-3rd dose — DIETARY_SUPPLEMENT
    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
  • Dupilumab — DRUG
    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

Study Details

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.

Key Dates

Start date
Jun 16, 2022
Status verified
Oct 2025
Primary completion
Jan 21, 2025
Completion
Jan 21, 2025

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study Group
    30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy) Dosing: \>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks 6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W

Primary Outcome Measure

Esophageal Eosinophilia (Number of Eosinophils in the Esophagus) [ Time Frame: week 24 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-

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By research site
Children's Hospital of Philadelphia· Philadelphia, PA

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