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NCT03656380 · ClinicalTrials.gov registry record · Phase 2
Mepo for Eosinophilic Esophagitis (EoE) Study
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
NCT03656380: Completed Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
NCT03656380 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03656380, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
Study Summary
Multi-center, randomized, double blind, parallel-arm, placebo controlled trial to determine whether mepolizumab is more effective than placebo for improving symptoms of dysphagia and decreasing esophageal eosinophil counts in adults and adolescents with active eosinophilic esophagitis (EoE) after an initial 3 month treatment course, and will also assess the impact of an additional 3 months of treatment.
Primary Outcome
Dysphagia will be assessed by the Eosinophilic Esophagitis Symptom Activity Index (EEsAI) which measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
Interventions
- OTHER Placebo
- DRUG Mepolizumab 300 mg
- DRUG Mepolizumab 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2019-03-20 |
| Est. Completion | 2022-12-09 |
| Phase | Phase 2 |
What the finished NCT03656380 record still lists
NCT03656380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03656380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03656380 about?
NCT03656380 is a clinical study titled "Mepo for Eosinophilic Esophagitis (EoE) Study". Multi-center, randomized, double blind, parallel-arm, placebo controlled trial to determine whether mepolizumab is more effective than placebo for improving symptoms of dysphagia and decreasing esophageal eosinophil counts in adults and adolescents with active eosinophilic esophagitis (EoE) after an...
What is the current status of trial NCT03656380?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2019-03-20. Estimated completion is 2022-12-09.
What interventions are being tested in trial NCT03656380?
The interventions under investigation include: Placebo (OTHER), Mepolizumab 300 mg (DRUG), Mepolizumab 100 mg (DRUG).
Who is sponsoring clinical trial NCT03656380?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03656380's enrollment target sits among peer trials
66 975th of 2000 higher than 1,014 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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