Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis

21-019416

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.

2022-06-16

2024-10-01

2024-12-18

Active (not recruiting)

Early phase I

21

Inclusion Criteria: 1. Males or females age 6 to 25 years 2. 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 3. History of either milk, egg, soy or wheat induced EoE based on the following criteria in the last two years 1. Addition of a single food lead to exacerbation of esophageal eosinophilia (increase of greater than 15 eos/hpf) or 2. Removal of a single food lead to normalization of biopsy (esophageal eosinophilia showed less than 6 eos/hpf) AND 3. History of either milk, egg, soy or wheat induced EoE based on introduction of the food and symptoms in the last 12 months 4. Weight \> 10 kg 5. Ability to remain on stable dose of Proton Pump Inhibitor (PPI) therapy throughout the study 6. Girls \> 11 years of age must have a negative urine/serum pregnancy test. 7. Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria: 1. Tracheo-esophageal fistulas, inflammatory bowel disease, Barrett's disease, or other significant inflammatory disease of the gastrointestinal tract 2. Biopsy evidence of eosinophilic infiltration in any other organ system 3. History of significant esophageal procedures e.g. sclerotherapy or esophagectomy 4. Systemic immunosuppressant usage in prior 3 months 5. Narrow caliber esophagus defined as the inability to pass a 9.5 mm endoscopy into the esophagus 6. IgE mediated reaction to food (milk, egg, soy or wheat) being introduced in the last 12 months 7. Therapy with biologic molecule (e.g. omalizumab, infliximab) in prior 12 months 8. Any factors that may pose a significant risk for undergoing anesthesia/sedation 9. Subjects undergoing any type of immunotherapy to any food (oral immunotherapy, sublingual immunotherapy, specific oral tolerance induction) within 3 months prior to Visit 1. 10. 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). 11. Allergy or known hypersensitivity to the dupilumab. 12. Subjects (or parents of subjects) with obvious excessive anxiety and unlikely to cope with the conditions of an upper Endoscopy and biopsy. 13. 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). 14. Participation in another clinical intervention study in the three months prior to Visit 1. 15. Subjects unable to follow the protocol and the protocol requirements. 16. Subjects on any experimental drugs or treatments. 17. Subjects unable to read/understand English or follow the protocol and the protocol requirements. 18. Subjects unable to read/understand English or follow the protocol and the protocol requirements. 19. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit or throughout the trial 20. Major elective surgeries are prohibited during the study 21. Female patients who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study 22. Women of children bearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 12 weeks after the last dose. This includes female patients who experience menarche during the study duration and who are unwilling to follow the precautions for WOCBP. 23. Chronic or acute infection requiring treatment with systemic antibiotic, antivirals, or antifungal within 2 weeks of baseline visits a. Patients maybe rescreened after infection resolves 24. Participants with active or suspected parasitic infection are excluded.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients receive active therapy', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 21, 'type': 'ACTUAL'}}

2024-05-07