NCT04856891

A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Duodenitis Who Have an Inadequate Response With, Lost Response to, or Were Intolerant to Standard Therapies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 94 (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 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

• Eosinophilic Duodenitis
• Eosinophilic Gastroenteritis

Interventions

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

Timeline

• Start date: 2021-05-20
• Primary completion: 2022-06-14
• Completion: 2023-01-09
• First posted: 2021-04-23
• Last updated: 2024-01-02
• Results posted: 2024-01-02

Locations

39 sites across 1 country: United States

Regulatory

• FDA-regulated drug study