Children's Hospital Colorado/University of Colorado School of Medicine
Aurora, Colorado, 80045, United States
Location status: Recruiting
NCT Number: NCT06705387
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
Interested in participating?
Request Info12 year–25 year
All sexes
Interventional
Phase 2
Aurora, Colorado, 80045, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subcutaneous injection of 300mg per week for 16 weeks.
Other names: Dupixent
Metered dose swallowed topical corticosteroid, given 1760mcg per day for 16 weeks.
Other names: Flovent
Time frame: From baseline endoscopy to the end of treatment at week 16.
Change in distensibility (mm) from baseline to end of treatment (continuous). This is measured by EndoFLIP.
Time frame: This will be measured at week 16 end of treatment.
The number of patients meeting a reduction in epithelial eosinophilia on esophageal biopsies of <15 eos/hpf at end of treatment.
Time frame: From screening to the end of treatment at week 16.
The change in daily symptoms as measured by the DSQ severity score from enrollment to end of treatment at week 16. A possible DSQ score can range between 0 and 84.
Contact information is provided by the study sponsor or research team.
University of Colorado, Denver
Other
DeTECTS: Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE
Acronym: DeTECTS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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