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

Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 25
Healthy Volunteers: f
View:

• Seen at CHCO for clinical care.

• Age 12 - 25 years old inclusive

• Weight ≥40 kg at the time of screening visit

• Confirmed EoE as diagnosed by biopsy with eosinophils ≥15 eosinophils/hpf in at least 2 esophageal regions at screening endoscopy

• Report of an average of at least 2 episodes of dysphagia per week in the 4 weeks prior to screening.

• Evidence of fibrostenotic features at time of screening endoscopy (grade 2 or 3 esophageal rings, stricture, delayed passage of barium tablet on fluoroscopy, and/or distensibility ≤15mm)

Locations
United States
Colorado
Children's Hospital Colorado/University of Colorado School of Medicine
RECRUITING
Aurora
Contact Information
Primary
Michelle Landis, BS
michelle.landis@childrenscolorado.org
720-777-8884
Time Frame
Start Date: 2024-12-23
Estimated Completion Date: 2027-03
Participants
Target number of participants: 72
Treatments
Active_comparator: dupilumab (also known as Dupixent)
Active_comparator: fluticasone (also known as Flovent)
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov