A Study to Assess Subcutaneous AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis — ENIGMA-SC

Eosinophilic Gastritis Clinical Trial

Official title:
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of Subcutaneous AK002 in Subjects With Moderate to Severe Eosinophilic Gastritis and/or Eosinophilic Duodenitis

Status Withdrawn

Clinical Trial Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacodynamic effect of subcutaneous lirentelimab (AK002), given monthly for 6 doses, in subjects with moderate to severe Eosinophilic Gastritis and/or Eosinophilic Duodenitis who have an inadequate response with, lost response to, or were intolerant to standard therapies.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05152563
Study type	Interventional
Source	Allakos Inc.
Contact
Status	Withdrawn
Phase	Phase 3
Start date	December 2021
Completion date	January 20, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03664960` - An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis	Phase 2
Recruiting	`NCT05831176` - A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis	Phase 2/Phase 3
Active, not recruiting	`NCT03678545` - Dupilumab in Eosinophilic Gastritis	Phase 2
Completed	`NCT04322604` - A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)	Phase 3
Completed	`NCT03496571` - A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis	Phase 2
Recruiting	`NCT02523118` - OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
Recruiting	`NCT05229432` - Study of Gastric Motility in Eosinophilic Gastritis
Withdrawn	`NCT01779154` - Eosinophilic Gastrointestinal Disorders Patient Registry	N/A
Completed	`NCT05251909` - Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)	Phase 3
Completed	`NCT04620811` - An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)	Phase 3
Completed	`NCT02897271` - Characteristics of Eosinophilic Gastritis, Enteritis, and Colitis in a Multi-Site Cohort