# Comparative study of dupilumab and fluticasone in management of fibrostenotic Eosinophilic Esophagitis; a pilot and feasibility clinical trial.

> **NIH NIH R01** · UNIVERSITY OF COLORADO DENVER · 2024 · $252,000

## Abstract

Project Abstract
Eosinophilic Esophagitis (EoE) is a chronic immune mediated inflammatory disease of the esophagus that has
emerged as a common cause of swallowing difficulty in children and adults leading to increased health care
utilization and negatively impacting quality of life. With rapidly increasing prevalence, clinical phenotypes have
emerged including a fibrostenotic phenotype (FS-EoE) defined by characteristic endoscopic appearance,
significant esophageal stiffness and narrowing. This phenotype has had lower treatment response and increased
symptom burden. Management guidelines do not yet provide a paradigm that consider symptom severity or the
presence of fibrostenosis and do not yet incorporate newly approved biologics for EoE. With the recent approval
of biologics targeting pathways implicated in the propagation of inflammation and fibrotic remodeling,
comparative studies that inform patients and providers alike on the effectiveness of alternate treatment strategies
are needed. The purpose of this small R01 proposal is to establish pilot data on the comparative effectiveness
and feasibility of a randomized clinical trial of dupilumab versus swallowed topical corticosteroid, fluticasone, in
the treatment of FS-EoE. This trial proposes the use of a novel and innovative outcome measure of treatment
response, distensibility as measured by EndoFLIP, for its ability to measure changes in esophageal narrowing
and association with patient reported symptoms. Biospecimens collected during the course of this trial, including
esophageal mucosal biopsies and a state-of-the-art Esophageal String Test, will be used to establish a
biorepository linked to trial outcome data to explore next step mechanistic questions related to treatment
response and esophageal remodeling in EoE. Results from this proposed study will lay the foundation for a
definitive multicenter comparative therapeutic trial for the management of FS-EoE.

## Key facts

- **NIH application ID:** 10880111
- **Project number:** 1R01DK135692-01A1
- **Recipient organization:** UNIVERSITY OF COLORADO DENVER
- **Principal Investigator:** CALIES D Menard-Katcher
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $252,000
- **Award type:** 1
- **Project period:** 2024-06-15 → 2027-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10880111

## Citation

> US National Institutes of Health, RePORTER application 10880111, Comparative study of dupilumab and fluticasone in management of fibrostenotic Eosinophilic Esophagitis; a pilot and feasibility clinical trial. (1R01DK135692-01A1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10880111. Licensed CC0.

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