NCT04322604

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

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Allakos Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Eosinophilic Gastritis
• Eosinophilic Duodenitis

Interventions

Type	Name	Description
DRUG	lirentelimab (AK002)	Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
OTHER	Placebo	Placebo

Timeline

• Start date: 2020-06-18
• Primary completion: 2021-11-29
• Completion: 2022-01-12
• First posted: 2020-03-26
• Last updated: 2024-01-02
• Results posted: 2024-01-02

Locations

60 sites across 1 country: United States

Regulatory

• FDA-regulated drug study