RECRUITING

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

Conditions

Eosinophilic Esophagitis Dupilumab Fluticasone

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-12-23

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06705387

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.

Ages Eligible for Study:12 Years to 25 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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)	* 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.

Inclusion Criteria

Exclusion 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)

* 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.

Contacts and Locations

Study Contact

Michelle Landis, BS

CONTACT

720-777-8884

michelle.landis@childrenscolorado.org

Study Locations (Sites)

Children's Hospital Colorado/University of Colorado School of Medicine

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

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 Registration Dates

Study Start Date2024-12-23

Study Completion Date2028-06

Study Record Updates

Study Start Date2024-12-23

Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

Dupilumab
Fluticasone

Additional Relevant MeSH Terms

Eosinophilic Esophagitis