Trials / Recruiting
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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Dupilumab | Subcutaneous injection of 300mg per week for 16 weeks. |
| DRUG | Fluticasone | Metered 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
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06705387. Inclusion in this directory is not an endorsement.