Dupilumab for Eosinophilic Esophagitis With Severe Strictures

The purpose of this research study is to determine how well an FDA-approved drug, dupilumab, works to treat patients with severe strictures and active Eosinophilic Esophagitis (EoE). This is an open-label study, meaning everyone in the study will receive dupilumab. Participants will have a screening visit where they will complete surveys and undergo an endoscopy (EGD). Blood and biopsies (small tissue samples) will also be collected. If eligible and enrolled into the study, participants will receive weekly subcutaneous (under the skin) injections of dupilumab for 52 weeks (one year). The first dose of dupilumab will be administered in the clinic at the enrollment visit (day 0) and participants (or their caregivers) will receive training on how to self-administer the remaining doses. Participants will return for study visits every at weeks 4, 8, 12, 18, 24, 30, 36, 44, and 52. During these visits, vital signs (temperature, heart rate, etc.) will be collected and participants will complete surveys. During visits at week 12, 24, and 52, blood will be collected and an endoscopy with biopsy will be performed. At 64 weeks (12 weeks after the last dose of dupilumab), participants assigned female at birth (AFAB) may be asked to come to the clinic for a urine pregnancy test.

NCT Number	NCT06352073
Lead Sponsor	University of North Carolina, Chapel Hill Collaborators: Regeneron Pharmaceuticals, Sanofi
Conditions	Eosinophilic Esophagitis, EoE
Enrollment	23 participants
Start Date	2024-05-16
Primary Completion	2026-04-16 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-04-29