Dupilumab for Eosinophilic Esophagitis With Severe Strictures

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06352073
Phase
PHASE4
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    300mg weekly subcutaneous injection

Study Details

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.

Key Dates

Start date
May 16, 2024
Status verified
Apr 2026
Primary completion
Apr 16, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Open Label dupilumab
    Open label dupilumab 300mg injection given subcutaneously weekly, for 52 weeks.

Primary Outcome Measure

Histologic Response to Dupilumab [ Time Frame: 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-

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By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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