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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04620811
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Allakos, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Henrik Rasmussen, MD, PhD
Principal Investigator Affiliation Allakos, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Gastritis, Eosinophilic Duodenitis
Arms & Interventions

Arms

Experimental: 3.0 mg/kg of Lirentelimab (AK002)

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

Interventions

Drug: - lirentelimab

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Allakos Investigational Site, Gilbert, Arizona

Status

Address

Allakos Investigational Site

Gilbert, Arizona, 85234

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Phoenix, Arizona

Status

Address

Allakos Investigational Site

Phoenix, Arizona, 85021

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Ventura, California

Status

Address

Allakos Investigational Site

Ventura, California, 93003

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Brandon, Florida

Status

Address

Allakos Investigational Site

Brandon, Florida, 33511

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Edgewater, Florida

Status

Address

Allakos Investigational Site

Edgewater, Florida, 32132

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Jacksonville, Florida

Status

Address

Allakos Investigational Site

Jacksonville, Florida, 32256

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Miami, Florida

Status

Address

Allakos Investigational Site

Miami, Florida, 33176

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, New Port Richey, Florida

Status

Address

Allakos Investigational Site

New Port Richey, Florida, 34653

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Crowley, Louisiana

Status

Address

Allakos Investigational Site

Crowley, Louisiana, 70526

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Rochester, Minnesota

Status

Address

Allakos Investigational Site

Rochester, Minnesota, 55905

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Reno, Nevada

Status

Address

Allakos Investigational Site

Reno, Nevada, 89511

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, New York, New York

Status

Address

Allakos Investigational Site

New York, New York, 10029

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Chapel Hill, North Carolina

Status

Address

Allakos Investigational Site

Chapel Hill, North Carolina, 27599

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Durham, North Carolina

Status

Address

Allakos Investigational Site

Durham, North Carolina, 27710

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Cincinnati, Ohio

Status

Address

Allakos Investigational Site

Cincinnati, Ohio, 45231

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Mentor, Ohio

Status

Address

Allakos Investigational Site

Mentor, Ohio, 44060

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Philadelphia, Pennsylvania

Status

Address

Allakos Investigational Site

Philadelphia, Pennsylvania, 19104

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Chattanooga, Tennessee

Status

Address

Allakos Investigational Site

Chattanooga, Tennessee, 37421

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Hixson, Tennessee

Status

Address

Allakos Investigational Site

Hixson, Tennessee, 37343

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Kingsport, Tennessee

Status

Address

Allakos Investigational Site

Kingsport, Tennessee, 37663

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Austin, Texas

Status

Address

Allakos Investigational Site

Austin, Texas, 78745

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Ogden, Utah

Status

Address

Allakos Investigational Site

Ogden, Utah, 84405

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Salt Lake City, Utah

Status

Address

Allakos Investigational Site

Salt Lake City, Utah, 84132

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Sandy, Utah

Status

Address

Allakos Investigational Site

Sandy, Utah, 84092

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Spokane, Washington

Status

Address

Allakos Investigational Site

Spokane, Washington, 99202

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

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