NCT03496571

A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Allakos Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, double-blind, randomized, placebo-controlled study to assess the effects of AK002, given monthly for 4 doses. It is hypothesized that AK002 is more effective than placebo control (alternative hypothesis) in reducing the number of eosinophils per high power field (HPF) in gastric and/or duodenal biopsies before and after receiving AK002 or placebo versus no difference between AK002 and placebo control (null hypothesis).

Conditions

• Eosinophilic Gastritis
• Eosinophilic Gastroenteritis

Interventions

Type	Name	Description
DRUG	AK002	AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
OTHER	Placebo	Placebo

Timeline

• Start date: 2018-07-18
• Primary completion: 2019-06-24
• Completion: 2019-06-24
• First posted: 2018-04-12
• Last updated: 2024-01-19
• Results posted: 2024-01-17

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study