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Dupilumab for Eosinophilic Esophagitis With Severe Strictures

Study acronym: DESTRICT
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Enrolling by Invitation to Active, Not Recruiting Enrollment target: estimated 30 to confirmed 23 · Primary completion date changed from estimate of May 2026 to Apr 16, 2026v6 Show 2 more changesShow less
    • Enrollment target: estimated 30 to confirmed 23
    • Primary completion date changed from estimate of May 2026 to Apr 16, 2026
  2. Trial status: Recruiting to Enrolling by Invitation Primary completion date: Feb 2026 to May 2026 · Completion date: Aug 2026 to Dec 2026 · Site details revisedv5 Show 3 more changesShow less
    • Primary completion date: Feb 2026 to May 2026
    • Completion date: Aug 2026 to Dec 2026
    • Site details revised
  3. Primary completion date: Dec 2025 to Feb 2026 Completion date: Jun 2026 to Aug 2026 · Eligibility criteria expanded, about 40 words · Study description shortened, about 35 wordsv4 Show 3 more changesShow less
    • Completion date: Jun 2026 to Aug 2026
    • Eligibility criteria expanded, about 40 words
    • Study description shortened, about 35 words

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Nov 2025 to Dec 2025 Completion date: Apr 2026 to Jun 2026 · Start date: May 9, 2024 to May 16, 2024 · Site contact updatedv3 Show 3 more changesShow less
    • Completion date: Apr 2026 to Jun 2026
    • Start date: May 9, 2024 to May 16, 2024
    • Site contact updated
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 2024 to May 9, 2024 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Apr 2024 to May 9, 2024
    • Site details revised
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06352073
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: Regeneron Pharmaceuticals, Sanofi
Conditions Eosinophilic Esophagitis, EoE
Enrollment 23 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov