Actively Recruiting
Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE
Led by University of Colorado, Denver · Updated on 2025-03-14
72
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Seen at CHCO for clinical care.
- Age 12 to 25 years old inclusive.
- Weight at least 40 kg at screening.
- Confirmed eosinophilic esophagitis diagnosed by biopsy showing 15 or more eosinophils per high power field in at least two esophageal regions at screening endoscopy.
- Average of at least 2 episodes of dysphagia per week in the 4 weeks before screening.
- Evidence of fibrostenotic features at screening endoscopy such as grade 2 or 3 esophageal rings, stricture, delayed barium tablet passage on fluoroscopy, or esophageal distensibility 15 mm or less.
You will not qualify if you...
- Esophageal dilation performed at index endoscopy.
- Patients undergoing dilation at index endoscopy may be rescreened if other criteria are met.
- Acute food impaction patients are excluded at therapeutic endoscopy but may enroll later if eligible.
- Patients on swallowed topical corticosteroids must be on stable dosing of 440 mcg twice daily or less for 3 months before enrollment.
- Dupilumab use in past 12 months for any indication excludes participation.
- Diet restrictions and proton pump inhibitor use must be stable for 8 weeks before index endoscopy and during study.
- Patients with fasting morning cortisol below 5 within 2 months before screening are excluded unless repeat cortisol is normal.
- Known other esophageal diseases or injuries (e.g., achalasia, fistula, congenital stricture, caustic injury, prior surgery), inflammatory bowel disease, liver disease, connective tissue disorder, or bleeding disorder exclude participation.
- Known gelatin allergy excludes participation due to Esophageal String Test collection.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital Colorado/University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
M
Michelle Landis, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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