Actively Recruiting
DeTECTS: Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic Eosinophilic Esophagitis
Led by University of Colorado, Denver · Updated on 2025-03-14
72
Participants Needed
1
Research Sites
25 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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Seen at CHCO for clinical care
- Age 12 to 25 years inclusive
- Weight at least 40 kg at screening
- Confirmed eosinophilic esophagitis diagnosed by biopsy with at least 15 eosinophils per high power field in 2 esophageal regions
- At least 2 episodes of dysphagia per week in the 4 weeks before screening
- Evidence of fibrostenotic features such as grade 2 or 3 esophageal rings, stricture, delayed barium tablet passage, or distensibility 15 mm or less at screening endoscopy
You will not qualify if you...
- Esophageal dilation performed at index endoscopy
- Acute food impaction at therapeutic endoscopy (may enroll later if eligible)
- Received dupilumab within the past 12 months
- Diet restrictions or proton pump inhibitor use not stable for 8 weeks before and during the study
- Fasting morning cortisol less than 5 within 2 months before screening (unless normal on repeat test)
- Other esophageal diseases or injuries such as achalasia, fistula, congenital stricture, caustic injury, or prior esophageal surgery
- Inflammatory bowel disease, liver disease, connective tissue disorders, or bleeding disorders
- Known gelatin allergy (excludes Esophageal String Test collection)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 16 weeks
Participants receive either weekly subcutaneous injections of Dupilumab or daily swallowed topical corticosteroids for 16 weeks to treat stenotic eosinophilic esophagitis.
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
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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