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

A Phase 3, Multicenter, Open-Label, Extension Study to Evaluate the Efficacy and Safety of AK002 in Patients That Were Previously Enrolled in AK002-016 or AK002-012 Studies and Have Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

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

Study Overview

• Status: Completed
• Conditions: Eosinophilic Gastritis; Eosinophilic Duodenitis
• Intervention / Treatment: Drug: lirentelimab

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Allakos Investigational Site 216-068
    • Huntsville, Alabama, United States, 35802
      • Allakos Investigational Site 216-002
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Allakos Investigational Site 216-035
  • California
    • Chula Vista, California, United States, 91910
      • Allakos Investigational Site 216-032
    • Santa Monica, California, United States, 90404
      • Allakos Investigational Site 216-014
    • Tustin, California, United States, 92780
      • Allakos Investigational Site 216-038
    • Walnut Creek, California, United States, 94598
      • Allakos Investigational Site 216-049
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Allakos Investigational Site 216-034
  • Florida
    • Brandon, Florida, United States, 33511
      • Allakos Investigational Site 216-063
    • Edgewater, Florida, United States, 32132
      • Allakos Investigational Site 216-027
    • Jacksonville, Florida, United States, 32256
      • Allakos Investigational Site 216-056
    • Miami, Florida, United States, 33176
      • Allakos Investigational Site 216-013
    • New Port Richey, Florida, United States, 34653
      • Allakos Investigational Site 216-053
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Allakos Investigational Site 216-007
  • Louisiana
    • Crowley, Louisiana, United States, 70526
      • Allakos Investigational Site 216-001
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Allakos Investigational Site 216-026
    • Boston, Massachusetts, United States, 02115
      • Allakos Investigational Site 216-052
    • Boston, Massachusetts, United States, 02215
      • Allakos Investigational Site 216-051
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Allakos Investigational Site 216-005
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Allakos Investigational Site 216-042
  • Nevada
    • Reno, Nevada, United States, 89511
      • Allakos Investigational Site 216-045
  • New York
    • New York, New York, United States, 10029
      • Allakos Investigational Site 216-025
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Allakos Investigational Site 216-020
    • Durham, North Carolina, United States, 27710
      • Allakos Investigational Site 216-048
    • Winston-Salem, North Carolina, United States, 27157
      • Allakos Investigational Site 216-050
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Allakos Investigational Site 216-031
    • Cincinnati, Ohio, United States, 45236
      • Allakos Investigational Site 216-028
    • Mentor, Ohio, United States, 44060
      • Allakos Investigational Site 216-044
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Allakos Investigational Site 216-021
  • Tennessee
    • Chattanooga, Tennessee, United States, 37343
      • Allakos Investigational Site 216-006
    • Chattanooga, Tennessee, United States, 37404
      • Allakos Investigational Site 216-003
    • Chattanooga, Tennessee, United States, 37421
      • Allakos Investigational Site 216-011
    • Kingsport, Tennessee, United States, 37663
      • Allakos Investigational Site 216-062
  • Texas
    • Austin, Texas, United States, 78742
      • Allakos Investigational Site 216-022
  • Utah
    • Ogden, Utah, United States, 84405
      • Allakos Investigational Site 216-039
    • Salt Lake City, Utah, United States, 84132
      • Allakos Investigational Site 216-030
    • Sandy, Utah, United States, 84092
      • Allakos Investigational Site 216-055
  • Washington
    • Spokane, Washington, United States, 99202
      • Allakos Investigational Site 216-064

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Provide written informed consent.
2. 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.
3. If patient is on pre-existing dietary restrictions, willingness to maintain those restrictions, throughout the study.
4. Able and willing to comply with all study procedures.
5. 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.
6. 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.

Key Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3.0 mg/kg of Lirentelimab (AK002); Subjects in this arm will receive up to 18 monthly doses (3mg/kg) of lirentelimab (AK002)	Drug: lirentelimab; Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8; Other Names: AK002

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Tissue Eosinophil Responders	A tissue eosinophil responder is defined as mean eosinophil count ≤4 cells/HPF in 5 gastric HPFs for EG only patients, ≤15 cells/HPF in 3 duodenal HPFs for EoD only patients, and ≤4 cells/HPF in 5 gastric HPFs and ≤15 cells/HPF in 3 duodenal HPFs for EG+EoD patients.	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	The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.	Main Study Baseline to Extension Weeks 71-72

Collaborators and Investigators

• Sponsor: Allakos Inc.
• Investigators: Study Director: Craig Patterson, MD, Allakos Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): July 7, 2023

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Hypersensitivity; Esophageal Diseases; Esophagitis; Duodenal Diseases; Leukocyte Disorders; Gastritis; Gastroenteritis; Eosinophilic Esophagitis; Enteritis; Eosinophilia; Duodenitis
• Other Study ID Numbers: AK002-016X

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No