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NCT03678545 · ClinicalTrials.gov registry record · Phase 2
Dupilumab in Eosinophilic Gastritis
A Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT03678545: Completed Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03678545 is a Phase 2 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03678545, a Phase 2 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
40 participants with Eosinophilic Gastritis 12-70 years of age will be randomly assigned with dupilumab or placebo subcutaneous injections every two weeks for a total of 12 weeks. Study subjects who complete the 12-week treatment phase, may continue into an open label extension study, where dupilumab will be administered every two weeks for a total of 24 weeks.
Primary Outcome
We will determine the Relative change from baseline of the peak eosinophil counts in the 5 most eosinophil dense HPFs in the gastric antrum and/or body between drug vs placebo at 12 weeks will be the primary measurement endpoint.
Interventions
- DRUG Placebo (blinded)
- DRUG Dupilumab (blinded)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2021-05-15 |
| Est. Completion | 2024-11-13 |
| Phase | Phase 2 |
What the finished NCT03678545 record still lists
NCT03678545 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo (blinded) is the first listed.
NCT03678545 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03678545 about?
NCT03678545 is a clinical study titled "Dupilumab in Eosinophilic Gastritis". 40 participants with Eosinophilic Gastritis 12-70 years of age will be randomly assigned with dupilumab or placebo subcutaneous injections every two weeks for a total of 12 weeks. Study subjects who complete the 12-week treatment phase, may continue into an open label extension study, where dupiluma...
What is the current status of trial NCT03678545?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2021-05-15. Estimated completion is 2024-11-13.
What interventions are being tested in trial NCT03678545?
The interventions under investigation include: Placebo (blinded) (DRUG), Dupilumab (blinded) (DRUG).
Who is sponsoring clinical trial NCT03678545?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03678545's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 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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