At a glance
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Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis
In Brief
A Phase 4 clinical trial evaluating Eosinophilic Esophagitis (EoE) food introduction-1st, Eosinophilic Esophagitis (E0E) food introduction-2nd, and 2 other interventions for Eosinophilic Esophagitis. Completed, enrolled 21 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
1 serving size of food proven to induce histologic and clinical symptoms in EoE
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
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
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