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Eosinophilic EsophagitisChildren's healthBiologicalDrugPhase 2

What this study is

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

What's being tested

  • Dupilumab

    Intervention · BIOLOGICAL

    Subcutaneous injection of 300mg per week for 16 weeks.

  • Fluticasone

    Intervention · DRUG

    Metered dose swallowed topical corticosteroid, given 1760mcg per day for 16 weeks.

Study details

Official title
DeTECTS: Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE
Sponsor
University of Colorado, Denver
Conditions
Eosinophilic Esophagitis
Enrolling
72 people
Starts
2024-12-23
Est. completion
2027-03
Design
Open-label, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗