NCT04322708

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

A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab (AK002) in Adult and Adolescent Patients With Active Eosinophilic Esophagitis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 277 (actual)
• Sponsor: Allakos Inc. · Industry
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2/3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002) given monthly for 6 doses in adult and adolescent patients with active eosinophilic esophagitis. 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 Esophagitis

Interventions

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

Timeline

• Start date: 2020-07-06
• Primary completion: 2021-06-04
• Completion: 2022-01-18
• First posted: 2020-03-26
• Last updated: 2024-01-02
• Results posted: 2024-01-02

Locations

78 sites across 3 countries: United States, Australia, Netherlands

Regulatory

• FDA-regulated drug study