A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

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 patients with moderately to severely active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosinophilic Gastroenteritis) who have an inadequate response with, lost response to, or were intolerant to standard therapies

Timeline

Start

2020-06-18

Primary completion

2021-11-29

Completion

2022-01-12

Outcome

Mixed primary results

registry p <0.0001; Percent Difference from Placebo 80.1 (95% CI 70.1 to 87.9) NCT04322604 ↗

registry p = 0.3427; LSM Difference from Placebo 1.5 (95% CI -1.6 to 4.7) NCT04322604 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	lirentelimab	Monoclonal antibody	3 mg/kg	—

Indications