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Dupilumab vs. Fluticasone for Eosinophilic Esophagitis

This study is looking at two treatments for Eosinophilic Esophagitis (EoE), a condition where a type of white blood cell (eosinophils) builds up in the esophagus, causing inflammation and difficulty swallowing. Researchers want to see if dupilumab (an injectable medicine) or swallowed fluticasone (a steroid spray) is better at improving the width of the esophagus and reducing inflammation. You might be able to join if you are 12 to 25 years old, weigh at least 40 kg, have a confirmed EoE diagnosis with a certain level of eosinophils, and experience difficulty swallowing at least twice a week. The study plans to enroll 72 participants.

Study design
This interventional study will compare dupilumab to swallowed fluticasone in 72 participants. It is designed to see if one treatment is more effective than the other.
What's involved
Participants will receive either dupilumab injections weekly or swallowed fluticasone daily for 16 weeks. Endoscopies will be performed at the beginning and end of treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at the end of treatment at week 16.

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NCT06705387

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

Recruiting
PHASE2Ages 12–25InterventionalTreatment
University of Colorado, Denver
~72 participants
Updated 2025-03-14 on ClinicalTrials.gov
What's tested:DupilumabFluticasone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Esophageal Lumen Distensibility
Measured over From baseline endoscopy to the end of treatment at week 16.
+1 more outcome measured

Conditions

Eosinophilic Esophagitis

Explore related trials

Eosinophilic Esophagitis

Where it's being run

1 sites across 1 states
Colorado1

Who to contact

Michelle Landis, BS
[email protected]
720-777-8884
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Esophageal Lumen DistensibilityFrom 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.

  • Reduction of epithelial eosinophilia to < 15 eos/hpf (binary)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.