A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis
Public ClinicalTrials.gov record NCT04856891. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Duodenitis Who Have an Inadequate Response With, Lost Response to, or Were Intolerant to Standard Therapies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04856891
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 94 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 20, 2021 (Actual)
- Primary completion
- Jun 14, 2022 (Actual)
- Completion
- Jan 9, 2023 (Actual)
- Last update posted
- Jan 2, 2024
2021 – 2023
United States locations
- U.S. sites
- 39
- U.S. states
- 17
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Allakos Investigational Site | Birmingham | Alabama | 35209 | — |
| Allakos Investigational Site | Gilbert | Arizona | 85234 | — |
| Allakos Investigational Site | Chula Vista | California | 91910 | — |
| Allakos Investigational Site | Lomita | California | 90717 | — |
| Allakos Investigational Site | Wheat Ridge | Colorado | 80033 | — |
| Allakos Investigational Site | Bristol | Connecticut | 06010 | — |
| Allakos Investigational Site | Hamden | Connecticut | 06518 | — |
| Allakos Investigational Site | Brandon | Florida | 33511 | — |
| Allakos Investigational Site | Edgewater | Florida | 32132 | — |
| Allakos Investigational Site | Jacksonville | Florida | 32256 | — |
| Allakos Investigational Site | Kissimmee | Florida | 34741 | — |
| Allakos Investigational Site | Lakewood Rch | Florida | 34211 | — |
| Allakos Investigational Site | New Port Richey | Florida | 34653 | — |
| Allakos Investigational Site | Ponte Vedra | Florida | 32081 | — |
| Allakos Investigational Site | Crowley | Louisiana | 70526 | — |
| Allakos Investigational Site | Reno | Nevada | 89511 | — |
| Allakos Investigational Site | Florham Park | New Jersey | 07932 | — |
| Allakos Investigational Site | Great Neck | New York | 11023 | — |
| Allakos Investigational Site | Concord | North Carolina | 28027 | — |
| Allakos Investigational Site | Durham | North Carolina | 27710 | — |
| Allakos Investigational Site | Cincinnati | Ohio | 45219 | — |
| Allakos Investigational Site | Cincinnati | Ohio | 45231 | — |
| Allakos Investigational Site | Dayton | Ohio | 45415 | — |
| Allakos Investigational Site | Mentor | Ohio | 44094 | — |
| Allakos Investigational Site | Greenwood | South Carolina | 29646 | — |
| Allakos Investigational Site | Chattanooga | Tennessee | 37421 | — |
| Allakos Investigational Site | Hermitage | Tennessee | 37076 | — |
| Allakos Investigational Site | Hixson | Tennessee | 37343 | — |
| Allakos Investigational Site | Austin | Texas | 78745 | — |
| Allakos Investigational Site | Cedar Park | Texas | 78613 | — |
| Allakos Investigational Site | Fort Worth | Texas | 76104 | — |
| Allakos Investigational Site | Lubbock | Texas | 79410 | — |
| Allakos Investigational Site | San Antonio | Texas | 78229 | — |
| Allakos Investigational Site | Southlake | Texas | 76092 | — |
| Allakos Investigational Site | Webster | Texas | 77598 | — |
| Allakos Investigational Site | Ogden | Utah | 84405 | — |
| Allakos Investigational Site | Salt Lake City | Utah | 84132 | — |
| Allakos Investigational Site | Sandy City | Utah | 84092 | — |
| Allakos Investigational Site | Fredericksburg | Virginia | 22401 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04856891, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 2, 2024 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04856891 live on ClinicalTrials.gov.