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NCT03664960 · ClinicalTrials.gov registry record · Phase 2
An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis
A Phase 2 study of Eosinophilic Gastroenteritis and Eosinophilic Gastritis, sponsored by Allakos.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 17
- Study locations
NCT03664960: Completed Phase 2 study of Eosinophilic Gastroenteritis and Eosinophilic Gastritis, sponsored by Allakos.
NCT03664960 is a Phase 2 study of Eosinophilic Gastroenteritis and Eosinophilic Gastritis that has completed, run by Allakos. The registered enrollment target is 58 participants, below the 401-participant average among 5 other Eosinophilic Gastroenteritis trials with a reported enrollment target (86% lower). The trial reports 17 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03664960, a Phase 2 study of Eosinophilic Gastroenteritis and Eosinophilic Gastritis, has completed, sponsored by Allakos.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 17
- Study locations
Study Summary
This is a Phase 2, open-label, extension study to assess the safety and tolerability of AK002, given monthly for up to 26 doses.
Primary Outcome
Adverse events assessed using the CTCAE version 4.03
Conditions Studied
Interventions
- DRUG AK002
Study Locations (17)
Arizona
- Phoenician Centers for Research and Innovation - Phoenix
- Mayo Clinic Arizona - Scottsdale
Tennessee
- ClinSearch - Chattanooga
- Vanderbilt University - Nashville
California
- Ventura Clinical Trials - Ventura
Florida
- Advanced Research Institute - New Port Richey
Illinois
- Northwestern - Chicago
Iowa
- University of Iowa - Iowa City
Maryland
- NIH - Bethesda
Massachusetts
- Tufts Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2018-11-14 |
| Est. Completion | 2021-11-02 |
| Phase | Phase 2 |
What the finished NCT03664960 record still lists
NCT03664960 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 401-participant average among 5 other Eosinophilic Gastroenteritis trials with a reported enrollment target (86% lower).
The record links to 3 conditions, with Eosinophilic Gastroenteritis appearing as the primary indexed condition, and to 1 intervention - of which AK002 is the first listed.
NCT03664960 lists 17 locations in 15 states (Arizona, Tennessee, California).
Frequently Asked Questions
What is clinical trial NCT03664960 about?
NCT03664960 is a clinical study titled "An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis". This is a Phase 2, open-label, extension study to assess the safety and tolerability of AK002, given monthly for up to 26 doses.
What is the current status of trial NCT03664960?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2018-11-14. Estimated completion is 2021-11-02.
What conditions does trial NCT03664960 study?
This clinical trial studies the following conditions: Eosinophilic Gastroenteritis, Eosinophilic Gastritis, Eosinophilic Duodenitis.
What interventions are being tested in trial NCT03664960?
The interventions under investigation include: AK002 (DRUG).
Who is sponsoring clinical trial NCT03664960?
This trial is sponsored by Allakos, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03664960 being conducted?
This trial has 17 study locations across Arizona, California, Florida, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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