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NCT04322604 · ClinicalTrials.gov registry record · Phase 3

A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

A Phase 3 study, sponsored by Allakos.

Completed
Registry status
Phase 3
Development phase
181
Enrollment target

NCT04322604 is a Phase 3 study that has completed, run by Allakos. The registered enrollment target is 181 participants.

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The verdict

NCT04322604, a Phase 3 study, has completed, sponsored by Allakos.

COMPLETED
Registry status
Phase 3
Development phase
181 participants
Enrollment target

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 patients with moderately to severely active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosinophilic Gastroenteritis) who have an inadequate response with, lost response to, or were intolerant to standard therapies

Interventions

  • OTHER Placebo
  • DRUG lirentelimab (AK002)

Trial Details

FieldValue
Enrollment Target 181 participants
Start Date 2020-06-18
Est. Completion 2022-01-12
Phase Phase 3

Sponsor

Allakos

15 total trials

What the Registry Record Tells You About NCT04322604

The ClinicalTrials.gov registry entry for NCT04322604 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allakos, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04322604 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04322604 about?

NCT04322604 is a clinical study titled "A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)". 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 patients with moderately to severely active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosi...

What is the current status of trial NCT04322604?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 181 participants. The study started on 2020-06-18. Estimated completion is 2022-01-12.

What interventions are being tested in trial NCT04322604?

The interventions under investigation include: Placebo (OTHER), lirentelimab (AK002) (DRUG).

Who is sponsoring clinical trial NCT04322604?

This trial is sponsored by Allakos, which has 15 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.