NCT07358234

Comparison of Eohilia With Dupixent on Esophagus Diameter in Patients With Eosinophilic Esophagitis.

Prospective Trial Comparing Swallowed Topical Budesonide With Subcutaneous Dupilumab on Esophageal Diameter and Fibrotic Change in Eosinophilic Esophagitis

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare Eosinophilic Esophagitis treatments Eohilia with Dupixent in their effects on diameter and scarring of the esophagus.

Detailed description

Eosinophilic esophagitis (EoE) is a chronic disease mediated by environmental allergens and type 2 immune inflammation which causes significant symptoms, food impactions, and stenosis. EoE is associated with significant esophageal stricturing disease. In particular, the odds of developing fibrostenotic disease in EoE more than double per decade of life, and the longer symptoms are present prior to diagnosis and treatment, the higher the likelihood of esophageal strictures being present. Dupilumab and budesonide oral suspension are key treatments for EoE. Dupilumab was FDA approved for EoE in 2022 and inhibits IL-4 and IL-13 signaling which mediate type-2 inflammation and may have an anti-fibrotic effect. IL-13 promotes M2 macrophage polarization, and a recent study showed fibrosis was macrophage-dependent in a mouse model of EoE. Swallowed topical steroids have been used off label in patients with EoE for several years with studies showing effects on improvement in esophageal diameter and reduction in esophageal strictures. The budesonide oral suspension was recently FDA approved in 2024. Further study is needed to understand the effect of these treatments on esophageal stenosis and fibrosis as no clinical trials have compared these treatments or their effects on esophageal diameter to date. Barium esophagram and functional lumen imaging probe (FLIP) are important tools used to measure esophageal diameter in EoE. The investigators hypothesize that dupilumab is superior to topical budesonide oral suspension for its effect on esophagram minimum diameter and FLIP distensibility plateau in EoE patients. • Primary Efficacy Endpoint: Alternative Hypothesis: There will be a greater increase in minimum esophageal diameter in patients receiving dupilumab compared to budesonide oral suspension at 12 weeks. • Secondary Efficacy Endpoint(s): Alternative Hypothesis: There will be greater distensibility on EndoFLIP topography in patients receiving dupilumab compared to budesonide oral suspension at 12 weeks. Symptoms, endoscopic findings, and histologic severity will be improved in patients receiving dupilumab compared to budesonide oral suspension at 12 weeks. Lamina propria fibrosis and collagen fiber density as determined by second harmonic generation microscopy will be improved in the dupilumab group in comparison to the budesonide oral suspension group.

Conditions

• Eosinophilic Esophagitis (EoE)

Interventions

Type	Name	Description
DRUG	Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]	300 mg weekly injection
DRUG	budesonide oral suspension	2mg twice daily

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2026-01-22
• Last updated: 2026-01-22

Regulatory

• FDA-regulated drug study