A Phase 2 interventional study of Dupilumab and Fluticasone in Eosinophilic Esophagitis, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 12 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Treatment
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:
Exclusion Criteria:
Biological: Dupilumab
Drug: Fluticasone
Subcutaneous injection of 300mg per week for 16 weeks.
Also known as: Dupixent
Metered dose swallowed topical corticosteroid, given 1760mcg per day for 16 weeks.
Also known as: Flovent
Esophageal Lumen Distensibility
Change in distensibility (mm) from baseline to end of treatment (continuous). This is measured by EndoFLIP.
Time frame: From baseline endoscopy to the end of treatment at week 16.
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.
Time frame: This will be measured at week 16 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.
Time frame: From screening to the end of treatment at week 16.
Plan to share: No
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University of Colorado, Denver