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NCT06352073 · ClinicalTrials.gov registry record · Phase 4
Dupilumab for Eosinophilic Esophagitis With Severe Strictures
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Active
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT06352073 is a Phase 4 study that is active but no longer recruiting, run by University of North Carolina, Chapel Hill. The registered enrollment target is 23 participants.
The verdict
NCT06352073, a Phase 4 study, is active but no longer recruiting, sponsored by University of North Carolina, Chapel Hill.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study 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.
Interventions
- DRUG Dupilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2024-05-16 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06352073
The ClinicalTrials.gov registry entry for NCT06352073 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dupilumab is the first listed.
NCT06352073 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06352073 about?
NCT06352073 is a clinical study titled "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 screenin...
What is the current status of trial NCT06352073?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2024-05-16. Estimated completion is 2026-12.
What interventions are being tested in trial NCT06352073?
The interventions under investigation include: Dupilumab (DRUG).
Who is sponsoring clinical trial NCT06352073?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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