DeTECTS: Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE
University of Colorado, Denver
Summary
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
Eligibility
- Age range
- 12–25 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Report of an average of at least 2 episodes of dysphagia per week in the 4 weeks prior to screening. * Evidence of fibrostenotic features at time of screening endoscopy (grade 2 or 3 esophageal rings, stricture, delayed passage of barium tablet on fluoroscopy, and/or distensibility ≤15mm) Exclusion Criteria: * Esophageal dilat…
Interventions
- BiologicalDupilumab
Subcutaneous injection of 300mg per week for 16 weeks.
- DrugFluticasone
Metered dose swallowed topical corticosteroid, given 1760mcg per day for 16 weeks.
Location
- Children's Hospital Colorado/University of Colorado School of MedicineAurora, Colorado