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NCT04856891 · ClinicalTrials.gov registry record · Phase 3
A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis
A Phase 3 study of Eosinophilic Gastroenteritis and Eosinophilic Duodenitis, sponsored by Allakos.
- Completed
- Registry status
- Phase 3
- Development phase
- 94
- Enrollment target
- 20
- Study locations
NCT04856891: Completed Phase 3 study of Eosinophilic Gastroenteritis and Eosinophilic Duodenitis, sponsored by Allakos.
NCT04856891 is a Phase 3 study of Eosinophilic Gastroenteritis and Eosinophilic Duodenitis that has completed, run by Allakos. The registered enrollment target is 94 participants, below the 394-participant average among 5 other Eosinophilic Gastroenteritis trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04856891, a Phase 3 study of Eosinophilic Gastroenteritis and Eosinophilic Duodenitis, has completed, sponsored by Allakos.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 94 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002) given monthly for 6 doses in adult patients with active eosinophilic duodenitis. Subjects who complete the randomized, double-blind, placebo-controlled treatment may have the option to receive 6 doses of open-label lirentelimab (AK002) through the OLE Period of the study.
Primary Outcome
A tissue eosinophil responder is defined as mean eosinophil count \<=15 cells/HPF in 3 duodenal HPFs
Conditions Studied
Interventions
- OTHER Placebo
- DRUG AK002
Study Locations (20)
Florida
- Allakos Investigational Site - Brandon
- Allakos Investigational Site - Edgewater
- Allakos Investigational Site - Jacksonville
- Allakos Investigational Site - Kissimmee
- Allakos Investigational Site - Lakewood Rch
- Allakos Investigational Site - New Port Richey
- Allakos Investigational Site - Ponte Vedra
California
- Allakos Investigational Site - Chula Vista
- Allakos Investigational Site - Lomita
Connecticut
- Allakos Investigational Site - Bristol
- Allakos Investigational Site - Hamden
North Carolina
- Allakos Investigational Site - Concord
- Allakos Investigational Site - Durham
Alabama
- Allakos Investigational Site - Birmingham
Arizona
- Allakos Investigational Site - Gilbert
Colorado
- Allakos Investigational Site - Wheat Ridge
Louisiana
- Allakos Investigational Site - Crowley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2021-05-20 |
| Est. Completion | 2023-01-09 |
| Phase | Phase 3 |
What the finished NCT04856891 record still lists
NCT04856891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 394-participant average among 5 other Eosinophilic Gastroenteritis trials with a reported enrollment target (76% lower).
The record links to 2 conditions, with Eosinophilic Gastroenteritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04856891 names 20 study sites across 11 states, led by Florida, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT04856891 about?
NCT04856891 is a clinical study titled "A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis". This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002) given monthly for 6 doses in adult patients with active eosinophilic duodenitis. Subjects who complete the randomized, double-blind, placebo-controlled treatm...
What is the current status of trial NCT04856891?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 94 participants. The study started on 2021-05-20. Estimated completion is 2023-01-09.
What conditions does trial NCT04856891 study?
This clinical trial studies the following conditions: Eosinophilic Gastroenteritis, Eosinophilic Duodenitis.
What interventions are being tested in trial NCT04856891?
The interventions under investigation include: Placebo (OTHER), AK002 (DRUG).
Who is sponsoring clinical trial NCT04856891?
This trial is sponsored by Allakos, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04856891 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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