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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 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.

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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.

Conditions Studied

Eosinophilic Gastroenteritis Eosinophilic Duodenitis

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

FieldValue
Enrollment Target 94 participants
Start Date 2021-05-20
Est. Completion 2023-01-09
Phase Phase 3

Sponsor

Allakos

15 total trials

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What the Registry Record Tells You About NCT04856891

The ClinicalTrials.gov registry entry for NCT04856891 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 394-participant average among 5 other Eosinophilic Gastroenteritis trials with a reported enrollment target (76% lower). The listed sponsor is Allakos, which has 15 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.