drugset / Trial / NCT06705387

Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE

NCT06705387

RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2024-12-23
Primary completion
2026-09
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dupilumab Monoclonal antibody 300 mg Subcutaneous
Comparator Fluticasone Other / unclassified 1760 ug Oral