Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis
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.
Accepts Healthy Volunteers
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|Eligible Ages||6 Years - 25 Years|
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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Children's Hospital of Philadelphia|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Jonathan Spergel, MD, PhD|
|Principal Investigator Affiliation||Children's Hospital of Philadelphia|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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 subjects 6 to 25 years of age. In the initial 12 week period, patients will be start on dupilumab on the doses used in the phase 3 trials to control disease. If disease is controlled based on histologic and symptom control at week 12 endoscopy, patients will be start on EoE trigger food. The trigger foods will be based on both a combination of history and histology results. The food will have trigger EoE by histology in the last 2 years and symptoms in the last year when reintroduced into the diet. The study will focus on the the four most common foods that trigger EoE: milk, egg, wheat and soy. For the initial food introduction, the subjects will add one serving size of the food daily for 12 weeks. After 12 weeks, the subjects will have a 2nd endoscopy if the 2nd endoscopy is normal, the subjects will increase the trigger food to 2 serving sizes a day or add an additional trigger food. A 3rd endoscopy will be done if the patients increases the food amount or adds a new food at week 36 (12 weeks after adding the new food). If the subject does not increase or add new foods at week 24, the 3rd endoscopy will not be obtained. All subjects will have end of study endoscopy at week 48. If the subjects have abnormal endoscopy or increase in symptoms, the amount food will be reduced by 50% and repeat endoscopy will be obtained at the same time schedule-12 weeks later.
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
Dietary Supplement: - Eosinophilic Esophagitis (EoE) food introduction-1st
1 serving size of food proven to induce histologic and clinical symptoms in EoE
Dietary Supplement: - Eosinophilic Esophagitis (E0E) food introduction-2nd
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
Dietary Supplement: - Eosinophilic Esophagitis (EoE) Food introduction-3rd dose
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
Drug: - Dupilumab
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
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104