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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 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.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT04856891
Study type Interventional
Source Allakos, Inc.
Contact Henrik Rasmussen, MD, PhD
Phone 443-699-5230
Email [email protected]
Status Recruiting
Phase Phase 3
Start date May 2021
Completion date July 2022

See also
  Status Clinical Trial Phase
Completed NCT03320369 - Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis N/A
Completed NCT00148603 - Montelukast in the Treatment of Duodenal Eosinophilia N/A
Not yet recruiting NCT03678545 - Dupilumab in Eosinophilic Gastritis Phase 2
Active, not recruiting NCT03664960 - An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis Phase 2
Completed NCT00267475 - Data Bank for Eosinophilic Disorders N/A
Terminated NCT01814059 - Sirolimus for Eosinophil-Associated Gastrointestinal Disorders Phase 1
Recruiting NCT02523118 - OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
Recruiting NCT01793168 - Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Completed NCT03496571 - A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis Phase 2
Completed NCT00266565 - Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic Syndrome Phase 1/Phase 2
Terminated NCT01212016 - Immunopathogenesis of Food Allergy and Eosinophilic Gastrointestinal Disorders N/A
Active, not recruiting NCT02897271 - Characteristics of Eosinophilic Gastritis, Enteritis, and Colitis in a Multi-Site Cohort