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An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

NCT04620811 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2024-04-22

Study results available
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Summary

This is a Phase 3, open-label, extension study to assess the long term efficacy and safety of lirentelimab given monthly.

Conditions

  • Eosinophilic Gastritis
  • Eosinophilic Duodenitis

Interventions

DRUG

lirentelimab

Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8

Sponsors & Collaborators

  • Allakos Inc.

    lead INDUSTRY

Principal Investigators

  • Craig Patterson, MD · Allakos Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-03
Primary Completion
2023-05-15
Completion
2023-07-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04620811 on ClinicalTrials.gov