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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06705387
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — BIOLOGICAL
    Subcutaneous injection of 300mg per week for 16 weeks.
  • Fluticasone — DRUG
    Metered dose swallowed topical corticosteroid, given 1760mcg per day for 16 weeks.

Study Details

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

Key Dates

Start date
Dec 23, 2024
Status verified
Mar 2025
Primary completion
Sep 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: dupilumab (also known as Dupixent)
  • Active Comparator: fluticasone (also known as Flovent)

Primary Outcome Measure

Esophageal Lumen Distensibility [ Time Frame: From baseline endoscopy to the end of treatment at week 16. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital Colorado/University of Colorado School of MedicineAuroraColorado80045
Clinical Research Supervisor | Digestive Health Institute
[email protected]
720-777-8884

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By research site
Children's Hospital Colorado/University of Colorado School of Medicine· Aurora, CO

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