Clinical Trials Directory

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RecruitingNCT06705387

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

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

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
72 (estimated)
Sponsor
University of Colorado, Denver · Academic / Other
Sex
All
Age
12 Years – 25 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
BIOLOGICALDupilumabSubcutaneous injection of 300mg per week for 16 weeks.
DRUGFluticasoneMetered dose swallowed topical corticosteroid, given 1760mcg per day for 16 weeks.

Timeline

Start date
2024-12-23
Primary completion
2026-09-01
Completion
2027-03-01
First posted
2024-11-26
Last updated
2025-03-14

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT06705387. Inclusion in this directory is not an endorsement.