Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis
NCT04856891 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04856891
The ClinicalTrials.gov registry entry for NCT04856891 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allakos, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04856891 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04856891?
The interventions under investigation include: Placebo (OTHER), AK002 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04856891?
This trial is sponsored by Allakos, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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