The goal of this clinical trial is to \[primary purpose: e.g., learn if intervention or health behavior can treat, prevent, diagnose etc.\] in \[describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers\]. The main question\[s\] it aims to answer \[is/are\]:
Does dupilumab or swallowed topical fluticasone improve the diameter of the esophagus more? Does dupilumab or swallowed topical fluticasone reduce inflammation in the esophagus more? Are comparative effective clinical trials feasible in this patient population?
Researchers will compare dupilumab 300 mg weekly compared to swallowed fluticasone to see if there is a difference in treatment response.
Participants will be asked to:
* Be randomized to either dupilumab sq weekly or swallowed topical fluticasone twice daily. * Participate in 8 study visits over 52 weeks * Complete questionnaires * Have an endoscopy with biopsies and EndoFLIP measurements. * Swallow an Esophageal String Test
Seen at CHCO for clinical care.
Age 12 - 25 years old inclusive
Weight ≥40 kg at the time of screening visit
Confirmed EoE as diagnosed by biopsy with eosinophils ≥15 eosinophils/hpf in at least 2 esophageal regions at screening endoscopy
Esophageal dilation performed at index endoscopy
Patients with stricture undergoing dilation at index endoscopy may be rescreened if they meet all other eligibility criteria.
Patients with acute food impaction will not be enrolled at their therapeutic endoscopy but are eligible for enrollment subsequently if they meet all other eligibility criteria.
Eligible patients on current STCs can be enrolled but need to be on stable dosing less than or equal to 440 mcg two times daily fluticasone equivalent for 3 months prior to enrollment.
Parallel
Dupilumab
Biological/VaccineSubcutaneous injection of 300mg per week for 16 weeks.
Fluticasone
DrugMetered dose swallowed topical corticosteroid, given 1760mcg per day for 16 weeks.
Esophageal Lumen Distensibility
Change in distensibility (mm) from baseline to end of treatment (continuous). This is measured by EndoFLIP.
Reduction of epithelial eosinophilia to < 15 eos/hpf (binary)
The number of patients meeting a reduction in epithelial eosinophilia on esophageal biopsies of \<15 eos/hpf at end of treatment.
Change in daily symptom questionnaire (DSQ) severity score
The change in daily symptoms as measured by the DSQ severity score from enrollment to end of treatment at week 16. A possible DSQ score can range between 0 and 84.
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University of Colorado, Denver
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
