Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis
Eosinophilic Esophagitis
About this trial
This is an interventional treatment trial for Eosinophilic Esophagitis
Eligibility Criteria
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)
a) History of endoscopy with a peak count of >15 eosinophils per high powered field meeting consensus criteria for Eosinophilic Esophagitis1
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
- Girls > 11 years of age must have a negative urine/serum pregnancy test.
- Parental/guardian permission (informed consent) and if appropriate, child assent.
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
- Narrow caliber esophagus defined as the inability to pass a 9.5 mm endoscopy into the esophagus
- IgE mediated reaction to food (milk, egg, soy or wheat) being introduced in the last 12 months
- Therapy with biologic molecule (e.g. omalizumab, infliximab) in prior 12 months
- Any factors that may pose a significant risk for undergoing anesthesia/sedation
- Subjects undergoing any type of immunotherapy to any food (oral immunotherapy, sublingual immunotherapy, specific oral tolerance induction) within 3 months prior to Visit 1.
- Active IgE- mediated milk, egg, wheat or soy allergy based on skin test or history (if those foods are being introduced back into the diet).
- Allergy or known hypersensitivity to the dupilumab.
- Subjects (or parents of subjects) with obvious excessive anxiety and unlikely to cope with the conditions of an upper Endoscopy and biopsy.
- Past or current disease(s), which in the opinion of the Investigator or the Sponsor, may affect the subject's participation in this study, including but not limited to active autoimmune disorders, immunodeficiency, malignancy, uncontrolled diseases (hypertension, psychiatric (especially anxiety), cardiac), or other disorders (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders).
- Participation in another clinical intervention study in the three months prior to Visit 1.
- Subjects unable to follow the protocol and the protocol requirements.
- Subjects on any experimental drugs or treatments.
- Subjects unable to read/understand English or follow the protocol and the protocol requirements.
Sites / Locations
- Children's Hospital of PhiladelphiaRecruiting
Arms of the Study
Arm 1
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