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NCT05251909 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
A Phase 3 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 3
- Development phase
- 12
- Enrollment target
NCT05251909: Clinical Trial Phase 3 study, sponsored by AstraZeneca.
NCT05251909 is a Phase 3 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 12 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05251909, a Phase 3 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a 3-part study. Part A is randomized, double-blinded, placebo-controlled and includes patients with eosinophilic gastritis and/or duodenal-only disease. After completing Part A, participants can continue to Part C - open-label benralizumab treatment period. Following the decision to close enrollment, patients in both Part A and Part C will be given the option to proceed to 6-months of open-label benralizumab treatment in Part D.
Primary Outcome
the proportion of patients achieving a histological response at Week 24, is defined as below: * 6 eosinophils/hpf in the stomach for the patients with only gastric disease at baseline. * 6 eosinophils/hpf in the stomach and ≤15 eosinophils/hpf in the duodenum for the patients with gastric + duodenal disease at baseline. * 15 eosinophils/hpf in the duodenum for the patients with only duodenal disease at baseline.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Benralizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-01-18 |
| Est. Completion | 2024-02-13 |
| Phase | Phase 3 |
Why NCT05251909 stopped before completion
NCT05251909 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05251909 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05251909 about?
NCT05251909 is a clinical study titled "Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)". This is a 3-part study. Part A is randomized, double-blinded, placebo-controlled and includes patients with eosinophilic gastritis and/or duodenal-only disease. After completing Part A, participants can continue to Part C - open-label benralizumab treatment period. Following the decision to close en...
What is the current status of trial NCT05251909?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 12 participants. The study started on 2022-01-18. Estimated completion is 2024-02-13.
What interventions are being tested in trial NCT05251909?
The interventions under investigation include: Placebo (BIOLOGICAL), Benralizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05251909?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05251909's enrollment target sits among peer trials
12 1984th of 2000 higher than 12 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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