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ENROLLING BY INVITATION
NCT06352073
PHASE4

Dupilumab for Eosinophilic Esophagitis With Severe Strictures

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

Summary

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.

Official title: Dupilumab for Eosinophilic Esophagitis With Severe Strictures (DESTRICT Study)

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-05-16

Completion Date

2026-12

Last Updated

2025-12-11

Healthy Volunteers

No

Interventions

DRUG

Dupilumab

300mg weekly subcutaneous injection

Locations (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States