Recruiting
Phase 2

Dupilumab vs. Topical Corticosteroid

Sponsor:

University of Colorado, Denver

Code:

NCT06705387

Conditions

Eosinophilic Esophagitis

Eligibility Criteria

Sex: All

Age: 12 - 25

Healthy Volunteers: Not accepted

Interventions

Dupilumab

Fluticasone

Study Details

Brief 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

Conditions

Eosinophilic Esophagitis

Study ID

NCT06705387

Start date

Dec 23, 2024

Status verified date

Mar, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 25

Healthy Volunteers: Not accepted

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 Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: dupilumab (also known as Dupixent)

active comparator: fluticasone (also known as Flovent)

Interventions

Dupilumab

Subcutaneous injection of 300mg per week for 16 weeks.

Fluticasone

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

Primary outcome measure

  • Esophageal Lumen Distensibility [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Michelle Landis, BS

720-777-8884michelle.landis@childrenscolorado.org

Locations

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

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Clinical Research Supervisor | Digestive Health Institute

720-777-8884michelle.landis@childrenscolorado.org

More Information

Sponsor

University of Colorado, Denver

Last update posted

Mar 14, 2025

Last verified

Mar, 2025

Keywords

  • Dupilumab
  • Fluticasone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-03-14.