NCT04620811

An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

A Phase 3, Multicenter, Open-Label, Extension Study to Evaluate the Efficacy and Safety of AK002 in Patients That Were Previously Enrolled in AK002-016 or AK002-012 Studies and Have Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Allakos Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, open-label, extension study to assess the long term efficacy and safety of lirentelimab given monthly.

Conditions

• Eosinophilic Gastritis
• Eosinophilic Duodenitis

Interventions

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

Timeline

• Start date: 2020-12-03
• Primary completion: 2023-05-15
• Completion: 2023-07-07
• First posted: 2020-11-09
• Last updated: 2024-04-22
• Results posted: 2024-04-18

Locations

38 sites across 1 country: United States

Regulatory

• FDA-regulated drug study