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A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis

NCT04856891 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2024-01-02

Study results available
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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 adult patients with active eosinophilic duodenitis. Subjects who complete the randomized, double-blind, placebo-controlled treatment may have the option to receive 6 doses of open-label lirentelimab (AK002) through the OLE Period of the study.

Conditions

  • Eosinophilic Duodenitis
  • Eosinophilic Gastroenteritis

Interventions

DRUG

AK002

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

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Allakos Inc.

    lead INDUSTRY

Principal Investigators

  • Craig Paterson, MD · Allakos Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2022-06-14
Completion
2023-01-09
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 NCT04856891 on ClinicalTrials.gov