Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis (NCT05247866) | Clinical Trial Compass
CompletedPhase 4
Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis
United States21 participantsStarted 2022-06-16
Plain-language 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.
Who can participate
Age range6 Years – 25 Years
SexALL
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Inclusion criteria
✓. Males or females age 6 to 25 years
✓. Diagnosis of Eosinophilic Esophagitis based on the most recent international consensus definition (Dellon et al, Gastroenterology 2019)
✓. History of either milk, egg, soy or wheat induced EoE based on the following criteria in the last two years
✓. Addition of a single food lead to exacerbation of esophageal eosinophilia (increase of greater than 15 eos/hpf) or
✓. Removal of a single food lead to normalization of biopsy (esophageal eosinophilia showed less than 6 eos/hpf) AND
✓. History of either milk, egg, soy or wheat induced EoE based on introduction of the food and symptoms in the last 12 months
✓. Weight \> 10 kg
✓. Ability to remain on stable dose of Proton Pump Inhibitor (PPI) therapy throughout the study
Exclusion criteria
✕. Tracheo-esophageal fistulas, inflammatory bowel disease, Barrett's disease, or other significant inflammatory disease of the gastrointestinal tract
✕. Biopsy evidence of eosinophilic infiltration in any other organ system
✕. History of significant esophageal procedures e.g. sclerotherapy or esophagectomy
✕. Systemic immunosuppressant usage in prior 3 months
What they're measuring
1
Esophageal Eosinophilia (Number of Eosinophils in the Esophagus)
Timeframe: week 24
2
Esophageal Eosinophilia (Number of Eosinophils in the Esophagus)
Timeframe: week 48
3
Esophageal Eosinophilia (Number of Eosinophils in the Esophagus)