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Clinical Trial 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


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04322604
Study type Interventional
Source Allakos Inc.
Contact
Status Completed
Phase Phase 3
Start date June 18, 2020
Completion date January 12, 2022

See also
  Status Clinical Trial Phase
Completed NCT03664960 - An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis Phase 2
Recruiting NCT05831176 - A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis Phase 2/Phase 3
Active, not recruiting NCT03678545 - Dupilumab in Eosinophilic Gastritis Phase 2
Completed NCT03496571 - A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis Phase 2
Recruiting NCT02523118 - OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
Recruiting NCT05229432 - Study of Gastric Motility in Eosinophilic Gastritis
Withdrawn NCT01779154 - Eosinophilic Gastrointestinal Disorders Patient Registry N/A
Completed NCT05251909 - Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study) Phase 3
Completed NCT04620811 - An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis) Phase 3
Withdrawn NCT05152563 - A Study to Assess Subcutaneous AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis Phase 3
Completed NCT02897271 - Characteristics of Eosinophilic Gastritis, Enteritis, and Colitis in a Multi-Site Cohort