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NCT03496571 · ClinicalTrials.gov registry record · Phase 2
A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis
A Phase 2 study, sponsored by Allakos.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
NCT03496571: Completed Phase 2 study, sponsored by Allakos.
NCT03496571 is a Phase 2 study that has completed, run by Allakos. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03496571, a Phase 2 study, has completed, sponsored by Allakos.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
Study Summary
This is a Phase 2, double-blind, randomized, placebo-controlled study to assess the effects of AK002, given monthly for 4 doses. It is hypothesized that AK002 is more effective than placebo control (alternative hypothesis) in reducing the number of eosinophils per high power field (HPF) in gastric and/or duodenal biopsies before and after receiving AK002 or placebo versus no difference between AK002 and placebo control (null hypothesis).
Primary Outcome
Tissue eosinophil count obtained in biopsy specimens from the stomach and/or duodenum using esophago-gastro- duodenoscopy (EGD)
Interventions
- OTHER Placebo
- DRUG AK002
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2018-07-18 |
| Est. Completion | 2019-06-24 |
| Phase | Phase 2 |
What the finished NCT03496571 record still lists
NCT03496571 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03496571 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03496571 about?
NCT03496571 is a clinical study titled "A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis". This is a Phase 2, double-blind, randomized, placebo-controlled study to assess the effects of AK002, given monthly for 4 doses. It is hypothesized that AK002 is more effective than placebo control (alternative hypothesis) in reducing the number of eosinophils per high power field (HPF) in gastric a...
What is the current status of trial NCT03496571?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2018-07-18. Estimated completion is 2019-06-24.
What interventions are being tested in trial NCT03496571?
The interventions under investigation include: Placebo (OTHER), AK002 (DRUG).
Who is sponsoring clinical trial NCT03496571?
This trial is sponsored by Allakos, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03496571's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 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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