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

NCT04620811 | Completed Phase 3 Results FDA Drug

• 1 other identifier: AK002-016X
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 38

Brief 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

Outcome Measures

Primary Outcomes (1)

• The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0

  Adverse events assessed using the CTCAE version 5.0.

  Through study completion, up to 21 months

Other Outcomes (2)

• Proportion of Tissue Eosinophil Responders

  At Follow-up EGD (Esophago-Gastro-Duodenoscopy) (Day 505 or 28 days after last dose if ET)

• Change in PRO Total System Score (TSS) From AK002-016/AK002-012 Baseline

  Main Study Baseline to Extension Weeks 71-72

Study Arms (1)

3.0 mg/kg of Lirentelimab (AK002)

EXPERIMENTAL

Subjects in this arm will receive up to 18 monthly doses (3mg/kg) of lirentelimab (AK002)

Drug: lirentelimab

Interventions

lirentelimab DRUG

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

Also known as: AK002

3.0 mg/kg of Lirentelimab (AK002)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent.
• Completed Study AK002-016, defined as having received 6 infusions of study drug and followed through Day 176 (±3) or completed Study AK002-012, defined as having received the cohort-appropriate amount of doses and followed for 5 months after last dose of study drug.
• If patient is on pre-existing dietary restrictions, willingness to maintain those restrictions, throughout the study.
• Able and willing to comply with all study procedures.
• Female patients must be either post-menopausal for at least 1 year or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity until the end of the study, or for 120 days following the last dose of study drug, whichever is longer.
• Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant at any time during study participation.

You may not qualify if:

• Known hypersensitivity to any constituent of the study drug.
• Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.
• Planned or expected vaccination with live attenuated vaccines during the Treatment Period, or vaccination expected within 5 half-lives (4 months) of AK002 administration.
• Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
• Any other reason that, in the opinion of the Investigator or Medical Monitor, makes the patient unsuitable for enrollment.

Sponsors & Collaborators

• Allakos Inc.: lead

Study Sites (38)

Allakos Investigational Site 216-068

Birmingham, Alabama, 35209, United States

Location

Allakos Investigational Site 216-002

Huntsville, Alabama, 35802, United States

Location

Allakos Investigational Site 216-035

Phoenix, Arizona, 85018, United States

Location

Allakos Investigational Site 216-032

Chula Vista, California, 91910, United States

Location

Allakos Investigational Site 216-014

Santa Monica, California, 90404, United States

Location

Allakos Investigational Site 216-038

Tustin, California, 92780, United States

Location

Allakos Investigational Site 216-049

Walnut Creek, California, 94598, United States

Location

Allakos Investigational Site 216-034

Aurora, Colorado, 80045, United States

Location

Allakos Investigational Site 216-063

Brandon, Florida, 33511, United States

Location

Allakos Investigational Site 216-027

Edgewater, Florida, 32132, United States

Location

Allakos Investigational Site 216-056

Jacksonville, Florida, 32256, United States

Location

Allakos Investigational Site 216-013

Miami, Florida, 33176, United States

Location

Allakos Investigational Site 216-053

New Port Richey, Florida, 34653, United States

Location

Allakos Investigational Site 216-007

Chicago, Illinois, 60611, United States

Location

Allakos Investigational Site 216-001

Crowley, Louisiana, 70526, United States

Location

Allakos Investigational Site 216-026

Boston, Massachusetts, 02111, United States

Location

Allakos Investigational Site 216-052

Boston, Massachusetts, 02115, United States

Location

Allakos Investigational Site 216-051

Boston, Massachusetts, 02215, United States

Location

Allakos Investigational Site 216-005

Rochester, Minnesota, 55905, United States

Location

Allakos Investigational Site 216-042

Kansas City, Missouri, 64108, United States

Location

Allakos Investigational Site 216-045

Reno, Nevada, 89511, United States

Location

Allakos Investigational Site 216-025

New York, New York, 10029, United States

Location

Allakos Investigational Site 216-020

Chapel Hill, North Carolina, 27599, United States

Location

Allakos Investigational Site 216-048

Durham, North Carolina, 27710, United States

Location

Allakos Investigational Site 216-050

Winston-Salem, North Carolina, 27157, United States

Location

Allakos Investigational Site 216-031

Cincinnati, Ohio, 45229, United States

Location

Allakos Investigational Site 216-028

Cincinnati, Ohio, 45236, United States

Location

Allakos Investigational Site 216-044

Mentor, Ohio, 44060, United States

Location

Allakos Investigational Site 216-021

Philadelphia, Pennsylvania, 19104, United States

Location

Allakos Investigational Site 216-006

Chattanooga, Tennessee, 37343, United States

Location

Allakos Investigational Site 216-003

Chattanooga, Tennessee, 37404, United States

Location

Allakos Investigational Site 216-011

Chattanooga, Tennessee, 37421, United States

Location

Allakos Investigational Site 216-062

Kingsport, Tennessee, 37663, United States

Location

Allakos Investigational Site 216-022

Austin, Texas, 78742, United States

Location

Allakos Investigational Site 216-039

Ogden, Utah, 84405, United States

Location

Allakos Investigational Site 216-030

Salt Lake City, Utah, 84132, United States

Location

Allakos Investigational Site 216-055

Sandy City, Utah, 84092, United States

Location

Allakos Investigational Site 216-064

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Eosinophilic enteropathy

Interventions

AK002

Results Point of Contact

• Title: Medical Information
• Organization: Allakos

medinfo@allakos.com

650-597-5002

Study Officials

• Craig Patterson, MD

  Allakos Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: December 3, 2020
• Primary Completion: May 15, 2023
• Study Completion: July 7, 2023
• Last Updated: April 22, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-04

Locations

US (38)