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A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

Study Purpose

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 patients with moderately to severely active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosinophilic Gastroenteritis) who have an inadequate response with, lost response to, or were intolerant to standard therapies

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. Male or female aged ≥18 and ≤80 years at the time of signing the informed consent for entry. 3. Baseline endoscopic biopsy with ≥30 eosinophils/hpf in 5 hpf in the stomach and/or ≥30 eosinophils/hpf in 3 hpf in the duodenum, as determined by central histology assessment of biopsies collected during the screening EGD. 4. Completion of at least 4 daily PRO questionnaires per week for a minimum of 3 weeks during screening. 5. Patients with inadequate or loss of response to, or who were intolerant to standard therapies for EG/EoD symptoms, which could include PPI, antihistamines, systemic or topical corticosteroids, and/or diet, among others. 6. If patient is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study. 7. Willing and able to comply with all study procedures and visit schedule including follow-up visits. 8. Female patients must be either post-menopausal for at least 1 year with FSH level >30 mIU/mL at screening 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 from screening 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 from screening 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 (e.g., missed or later menstrual period) at any time during study participation. Key

Exclusion Criteria:

1. Use of systemic or topical corticosteroids exceeding the equivalent of 10 mg/day of prednisone within 4 weeks prior to the screening visit. 2. Change in the dose of corticosteroids (systemic or topical), PPI, leukotrienes, or diet therapy within 4 weeks prior to the screening visit. 3. Treatment with any immunosuppressive or immunomodulatory drugs that may interfere with the study within 12 weeks prior to the screening visit. 4. Prior exposure to AK002 or known hypersensitivity to any constituent of the study drug. 5. Active Helicobacter pylori infection, unless treated and confirmed to be negative prior to randomization and symptoms remain consistent. 6. History of inflammatory bowel disease, celiac disease, achalasia, or esophageal surgery. 7. History of bleeding disorders and/or esophageal varices. 8. Other causes of gastric and/or duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis (EGPA). 9. Confirmed diagnosis of Hypereosinophilic Syndrome (HES). 10. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study. 11. Presence of an abnormal laboratory value considered to be clinically significant by the Investigator. 12. Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk. 13. History of malignancy, except carcinoma in situ, early stage prostate cancer, or non-melanoma skin cancers. However, cancers that have been in remission for more than 5 years and are considered cured, can be enrolled (with the exception of breast cancer). 14. Treatment for a clinically significant helminthic parasitic infection within 6 months of screening. 15. Positive Ova and Parasite (O&P) test and/or seropositive for Strongyloides stercoralis. 16. Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives (4 months) of study drug administration. 17. Seropositive for HIV or hepatitis at screening, except for vaccinated patients or patients with past but resolved hepatitis, at screening. 18. Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to study drug administration (or 90 days or 5 half-lives, whichever is longer, for biologic products). 19. Known history of alcohol, drug, or other substance abuse or dependence, considered by the Investigator to be ongoing and clinically significant. 20. Any other reason that in the opinion of the Investigator or the 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.

NCT04322604
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 Recruiting
Countries United States
Conditions

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

Eosinophilic Gastritis, Eosinophilic Duodenitis
Arms & Interventions

Arms

Placebo Comparator: Placebo

Placebo

Experimental: 3 mg/kg of lirentelimab (AK002)

Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): a first dose of 1 mg/kg followed by 5 monthly doses of 3 mg/kg.

Interventions

Drug: - lirentelimab (AK002)

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

Other: - Placebo

Placebo

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, Huntsville, Alabama

Status

Recruiting

Address

Allakos Investigational Site

Huntsville, Alabama, 38801

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Gilbert, Arizona

Status

Recruiting

Address

Allakos Investigational Site

Gilbert, Arizona, 85234

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Scottsdale, Arizona

Status

Recruiting

Address

Allakos Investigational Site

Scottsdale, Arizona, 85259

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Little Rock, Arkansas

Status

Not yet recruiting

Address

Allakos Investigational Site

Little Rock, Arkansas, 72205

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, La Jolla, California

Status

Not yet recruiting

Address

Allakos Investigational Site

La Jolla, California, 92037

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Murrieta, California

Status

Recruiting

Address

Allakos Investigational Site

Murrieta, California, 92563

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Oakland, California

Status

Not yet recruiting

Address

Allakos Investigational Site

Oakland, California, 94612

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Santa Monica, California

Status

Recruiting

Address

Allakos Investigational Site

Santa Monica, California, 90404

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Tustin, California

Status

Recruiting

Address

Allakos Investigational Site

Tustin, California, 92780

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Ventura, California

Status

Recruiting

Address

Allakos Investigational Site

Ventura, California, 93003

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Walnut Creek, California

Status

Recruiting

Address

Allakos Investigational Site

Walnut Creek, California, 94598

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Aurora, Colorado

Status

Not yet recruiting

Address

Allakos Investigational Site

Aurora, Colorado, 80045

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Colorado Springs, Colorado

Status

Recruiting

Address

Allakos Investigational Site

Colorado Springs, Colorado, 80907

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Brandon, Florida

Status

Recruiting

Address

Allakos Investigational Site

Brandon, Florida, 33511

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Edgewater, Florida

Status

Recruiting

Address

Allakos Investigational Site

Edgewater, Florida, 32132

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Jacksonville, Florida

Status

Recruiting

Address

Allakos Investigational Site

Jacksonville, Florida, 32256

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Miami, Florida

Status

Recruiting

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

Recruiting

Address

Allakos Investigational Site

New Port Richey, Florida, 34653

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Chicago, Illinois

Status

Not yet recruiting

Address

Allakos Investigational Site

Chicago, Illinois, 60611

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Crowley, Louisiana

Status

Recruiting

Address

Allakos Investigational Site

Crowley, Louisiana, 70526

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Chevy Chase, Maryland

Status

Not yet recruiting

Address

Allakos Investigational Site

Chevy Chase, Maryland, 20815

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Boston, Massachusetts

Status

Recruiting

Address

Allakos Investigational Site

Boston, Massachusetts, 02111

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Boston, Massachusetts

Status

Not yet recruiting

Address

Allakos Investigational Site

Boston, Massachusetts, 02115

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Boston, Massachusetts

Status

Not yet recruiting

Address

Allakos Investigational Site

Boston, Massachusetts, 02215

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Ann Arbor, Michigan

Status

Not yet recruiting

Address

Allakos Investigational Site

Ann Arbor, Michigan, 48109

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Rochester, Minnesota

Status

Recruiting

Address

Allakos Investigational Site

Rochester, Minnesota, 55905

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Kansas City, Missouri

Status

Recruiting

Address

Allakos Investigational Site

Kansas City, Missouri, 64108

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Las Vegas, Nevada

Status

Not yet recruiting

Address

Allakos Investigational Site

Las Vegas, Nevada, 89106

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Reno, Nevada

Status

Recruiting

Address

Allakos Investigational Site

Reno, Nevada, 89511

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Great Neck, New York

Status

Recruiting

Address

Allakos Investigational Site

Great Neck, New York, 11021

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, New York, New York

Status

Recruiting

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

Recruiting

Address

Allakos Investigational Site

Chapel Hill, North Carolina, 27599

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Charlotte, North Carolina

Status

Recruiting

Address

Allakos Investigational Site

Charlotte, North Carolina, 28210

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Durham, North Carolina

Status

Recruiting

Address

Allakos Investigational Site

Durham, North Carolina, 27710

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Rocky Mount, North Carolina

Status

Recruiting

Address

Allakos Investigational Site

Rocky Mount, North Carolina, 27804

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Cincinnati, Ohio

Status

Recruiting

Address

Allakos Investigational Site

Cincinnati, Ohio, 45229

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Cincinnati, Ohio

Status

Recruiting

Address

Allakos Investigational Site

Cincinnati, Ohio, 45231

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Cleveland, Ohio

Status

Not yet recruiting

Address

Allakos Investigational Site

Cleveland, Ohio, 44106

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Dayton, Ohio

Status

Not yet recruiting

Address

Allakos Investigational Site

Dayton, Ohio, 45415

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Mentor, Ohio

Status

Recruiting

Address

Allakos Investigational Site

Mentor, Ohio, 44060

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Oklahoma City, Oklahoma

Status

Recruiting

Address

Allakos Investigational Site

Oklahoma City, Oklahoma, 73112

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Danville, Pennsylvania

Status

Not yet recruiting

Address

Allakos Investigational Site

Danville, Pennsylvania, 17822

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Philadelphia, Pennsylvania

Status

Recruiting

Address

Allakos Investigational Site

Philadelphia, Pennsylvania, 19104

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Chattanooga, Tennessee

Status

Recruiting

Address

Allakos Investigational Site

Chattanooga, Tennessee, 37421

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Hixson, Tennessee

Status

Recruiting

Address

Allakos Investigational Site

Hixson, Tennessee, 37343

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Kingsport, Tennessee

Status

Recruiting

Address

Allakos Investigational Site

Kingsport, Tennessee, 37663

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Nashville, Tennessee

Status

Recruiting

Address

Allakos Investigational Site

Nashville, Tennessee, 37212

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Austin, Texas

Status

Recruiting

Address

Allakos Investigational Site

Austin, Texas, 78704

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Houston, Texas

Status

Not yet recruiting

Address

Allakos Investigational Site

Houston, Texas, 77070

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Ogden, Utah

Status

Recruiting

Address

Allakos Investigational Site

Ogden, Utah, 84405

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Riverton, Utah

Status

Recruiting

Address

Allakos Investigational Site

Riverton, Utah, 84065

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Salt Lake City, Utah

Status

Recruiting

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

Recruiting

Address

Allakos Investigational Site

Sandy, Utah, 84092

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Fairfax, Virginia

Status

Not yet recruiting

Address

Allakos Investigational Site

Fairfax, Virginia, 22031

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Spokane, Washington

Status

Recruiting

Address

Allakos Investigational Site

Spokane, Washington, 99202

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

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