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Actively Recruiting

Phase 2
Age: 12Years - 25Years
All Genders
ID06705387

Comparing Dupilumab Injections and Swallowed Fluticasone for Treating Narrowing in Eosinophilic Esophagitis in Teens and Young Adults

Led by University of Colorado, Denver · Updated on 2025-03-14

72

Participants Needed

1

Research Sites

25 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to compare two treatments, dupilumab and swallowed topical fluticasone, in young people aged 12 to 25 years who have eosinophilic esophagitis EoE with narrowing of the esophagus. The study will explore which treatment better improves the esophagus diameter and reduces inflammation, and whether such comparative trials are possible in this patient group. Participants will be randomly assigned to receive either dupilumab as a 300 mg injection under the skin once a week or swallowed topical fluticasone at 1760 mcg daily in two doses. These treatments will be given for 16 weeks. The study includes 8 visits over 52 weeks, with assessments such as endoscopy with biopsies, EndoFLIP measurements of the esophagus, and the Esophageal String Test. During the study, participants will complete questionnaires and undergo several evaluations to monitor changes in symptoms and tissue inflammation. The main measurements include esophageal lumen distensibility and reduction of eosinophils in the esophageal tissue after 16 weeks of treatment. Safety and treatment effects will be followed up through the study period, which lasts one year.

CONDITIONS

Brief Title

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

Research Team

M

Michelle Landis, BS

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