Status:
COMPLETED
Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Regeneron Pharmaceuticals
Genzyme, a Sanofi Company
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
6-25 years
Phase:
PHASE4
Brief 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 medic...
Detailed Description
This study is an open label exploratory study to examine if patients controlled with dupilumab can successful introduce EoE trigger foods back into their diet. This is a single site study, enrolling ...
Eligibility Criteria
Inclusion
- 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
- 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.
- Subjects unable to read/understand English or follow the protocol and the protocol requirements.
- Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit or throughout the trial
- Major elective surgeries are prohibited during the study
- Female patients who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
- 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.
- 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
- Participants with active or suspected parasitic infection are excluded.
Key Trial Info
Start Date :
June 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2025
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05247866
Start Date
June 16 2022
End Date
January 21 2025
Last Update
November 10 2025
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104