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

Last updated: April 17, 2024
Sponsor: Allakos Inc.
Overall Status: Completed

Phase

3

Condition

Colic

Infectious Colitis

Gastrointestinal Diseases And Disorders

Treatment

lirentelimab

Clinical Study ID

NCT04620811
AK002-016X
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Provide written informed consent.
  2. Completed Study AK002-016, defined as having received 6 infusions of study drug andfollowed through Day 176 (±3) or completed Study AK002-012, defined as having receivedthe cohort-appropriate amount of doses and followed for 5 months after last dose ofstudy drug.
  3. If patient is on pre-existing dietary restrictions, willingness to maintain thoserestrictions, 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 surgicallysterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3months, or if of childbearing potential, have a negative pregnancy test and agree touse dual methods of contraception, or abstain from sexual activity until the end ofthe 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 ahighly effective method of contraception until the end of the study or for 120 daysfollowing the last dose of study drug, whichever is longer. All fertile men withfemale partners of childbearing potential should be instructed to contact theInvestigator immediately if they suspect their partner might be pregnant at any timeduring study participation.

Exclusion

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 theopinion of the Investigator, would place the patient at increased risk.
  3. Planned or expected vaccination with live attenuated vaccines during the TreatmentPeriod, or vaccination expected within 5 half-lives (4 months) of AK002administration.
  4. Women who are pregnant, breastfeeding, or planning to become pregnant whileparticipating in the study.
  5. Any other reason that, in the opinion of the Investigator or Medical Monitor, makesthe patient unsuitable for enrollment.

Study Design

Total Participants: 159
Treatment Group(s): 1
Primary Treatment: lirentelimab
Phase: 3
Study Start date:
December 03, 2020
Estimated Completion Date:
July 07, 2023

Connect with a study center

  • Allakos Investigational Site 216-068

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Allakos Investigational Site 216-002

    Huntsville, Alabama 35802
    United States

    Site Not Available

  • Allakos Investigational Site

    Gilbert, Arizona 85234
    United States

    Site Not Available

  • Allakos Investigational Site

    Phoenix, Arizona 85021
    United States

    Site Not Available

  • Allakos Investigational Site 216-035

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Allakos Investigational Site 216-032

    Chula Vista, California 91910
    United States

    Site Not Available

  • Allakos Investigational Site 216-014

    Santa Monica, California 90404
    United States

    Site Not Available

  • Allakos Investigational Site 216-038

    Tustin, California 92780
    United States

    Site Not Available

  • Allakos Investigational Site

    Ventura, California 93003
    United States

    Site Not Available

  • Allakos Investigational Site 216-049

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Allakos Investigational Site 216-034

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Allakos Investigational Site

    Brandon, Florida 33511
    United States

    Site Not Available

  • Allakos Investigational Site 216-063

    Brandon, Florida 33511
    United States

    Site Not Available

  • Allakos Investigational Site

    Edgewater, Florida 32132
    United States

    Site Not Available

  • Allakos Investigational Site 216-027

    Edgewater, Florida 32132
    United States

    Site Not Available

  • Allakos Investigational Site

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Allakos Investigational Site 216-056

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Allakos Investigational Site

    Miami, Florida 33176
    United States

    Site Not Available

  • Allakos Investigational Site 216-013

    Miami, Florida 33176
    United States

    Site Not Available

  • Allakos Investigational Site

    New Port Richey, Florida 34653
    United States

    Site Not Available

  • Allakos Investigational Site 216-053

    New Port Richey, Florida 34653
    United States

    Site Not Available

  • Allakos Investigational Site 216-007

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Allakos Investigational Site

    Crowley, Louisiana 70526
    United States

    Site Not Available

  • Allakos Investigational Site 216-001

    Crowley, Louisiana 70526
    United States

    Site Not Available

  • Allakos Investigational Site 216-026

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Allakos Investigational Site 216-051

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Allakos Investigational Site 216-052

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Allakos Investigational Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Allakos Investigational Site 216-005

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Allakos Investigational Site 216-042

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Allakos Investigational Site

    Reno, Nevada 89511
    United States

    Site Not Available

  • Allakos Investigational Site 216-045

    Reno, Nevada 89511
    United States

    Site Not Available

  • Allakos Investigational Site

    New York, New York 10029
    United States

    Site Not Available

  • Allakos Investigational Site 216-025

    New York, New York 10029
    United States

    Site Not Available

  • Allakos Investigational Site

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Allakos Investigational Site 216-020

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Allakos Investigational Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Allakos Investigational Site 216-048

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Allakos Investigational Site 216-050

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Allakos Investigational Site

    Cincinnati, Ohio 45231
    United States

    Site Not Available

  • Allakos Investigational Site 216-028

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • Allakos Investigational Site 216-031

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Allakos Investigational Site

    Mentor, Ohio 44060
    United States

    Site Not Available

  • Allakos Investigational Site 216-044

    Mentor, Ohio 44060
    United States

    Site Not Available

  • Allakos Investigational Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Allakos Investigational Site 216-021

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Allakos Investigational Site

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Allakos Investigational Site 216-003

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Allakos Investigational Site 216-006

    Chattanooga, Tennessee 37343
    United States

    Site Not Available

  • Allakos Investigational Site 216-011

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Allakos Investigational Site

    Hixson, Tennessee 37343
    United States

    Site Not Available

  • Allakos Investigational Site

    Kingsport, Tennessee 37663
    United States

    Site Not Available

  • Allakos Investigational Site 216-062

    Kingsport, Tennessee 37663
    United States

    Site Not Available

  • Allakos Investigational Site

    Austin, Texas 78742
    United States

    Site Not Available

  • Allakos Investigational Site 216-022

    Austin, Texas 78742
    United States

    Site Not Available

  • Allakos Investigational Site

    Ogden, Utah 84405
    United States

    Site Not Available

  • Allakos Investigational Site 216-039

    Ogden, Utah 84405
    United States

    Site Not Available

  • Allakos Investigational Site

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Allakos Investigational Site 216-030

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Allakos Investigational Site

    Sandy, Utah 84092
    United States

    Site Not Available

  • Allakos Investigational Site 216-055

    Sandy, Utah 84092
    United States

    Site Not Available

  • Allakos Investigational Site

    Spokane, Washington 99202
    United States

    Site Not Available

  • Allakos Investigational Site 216-064

    Spokane, Washington 99202
    United States

    Site Not Available

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