drugset / Trial / NCT05152563

A Study to Assess Subcutaneous AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis

NCT05152563 ↗

Phase 3 Withdrawn Allakos Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-12
Primary completion
2022-01-20
Completion
2022-01-20

Outcome

Outcome not reported

Stopped: “Company decision”

Drugs

EvaluationDrugModalityDoseRoute
Subject lirentelimab Monoclonal antibody 150 mg Subcutaneous
Subject lirentelimab Monoclonal antibody 300 mg Subcutaneous
Subject lirentelimab Monoclonal antibody 450 mg Subcutaneous