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

March 13, 2025 updated by: University of Colorado, Denver

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado/University of Colorado School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Esophageal dilation performed at index endoscopy
  • Patients with stricture undergoing dilation at index endoscopy may be rescreened if they meet all other eligibility criteria.
  • Patients with acute food impaction will not be enrolled at their therapeutic endoscopy but are eligible for enrollment subsequently if they meet all other eligibility criteria.
  • Eligible patients on current STCs can be enrolled but need to be on stable dosing less than or equal to 440 mcg two times daily fluticasone equivalent for 3 months prior to enrollment.
  • Patients who have received dupilumab in the past 12 months for any indication are excluded.
  • Diet restrictions and PPI use must stay unchanged in the 8 weeks prior to index endoscopy and through the study period.
  • Patients with a fasting morning cortisol <5 within 2 months of screening will not be enrolled. If repeat cortisol levels are normal, patients can be reconsented.
  • Known other esophageal disease or esophageal injury (e.g. achalasia, tracheoesophageal fistula, congenital stricture, caustic injury, history of esophageal surgery), inflammatory bowel disease, liver disease, connective tissue disorder, or bleeding disorder.
  • Patients with a known gelatin allergy will be excluded from EST collection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: dupilumab (also known as Dupixent)
Biological: Dupilumab
Subcutaneous injection of 300mg per week for 16 weeks.
Other Names:
  • Dupixent
Active Comparator: fluticasone (also known as Flovent)
Drug: Fluticasone
Metered dose swallowed topical corticosteroid, given 1760mcg per day for 16 weeks.
Other Names:
  • Flovent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esophageal Lumen Distensibility
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.
From baseline endoscopy to the end of treatment at week 16.
Reduction of epithelial eosinophilia to < 15 eos/hpf (binary)
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.
This will be measured at week 16 end of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in daily symptom questionnaire (DSQ) severity score
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.
From screening to the end of treatment at week 16.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

November 22, 2024

First Posted (Actual)

November 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-2367
  • 1R01DK135692-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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