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A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis

Study Purpose

This is a Phase 2/3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002) given monthly for 6 doses in adult and adolescent patients with active eosinophilic esophagitis. Subjects who complete the randomized, double-blind, placebo-controlled treatment may have the option to receive 6 doses of open-label lirentelimab (AK002) through the OLE Period of the study.

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 12 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

1. Male or female aged ≥12 and ≤80 years at the time of signing ICF. 2. Confirmed diagnosis of EoE and esophageal intraepithelial eosinophilic infiltration of ≥15 eosinophils/hpf in 1 hpf from a biopsy collected during the Screening EGD without any other cause for the esophageal eosinophilia. 3. History (by patient report) of an average of ≥2 episodes of dysphagia with intake of solid foods per week during the 4 weeks prior to Screening. 4. Subjects must have failed or not be adequately controlled on standard of care treatments for EoE symptoms, which could include PPI, systemic or topical corticosteroids, and/or diet, among others. 5. If on an allowed treatment for EoE, stable dose for at least 4 weeks prior to Screening and willingness to continue that dose for the study duration. 6. If patient is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study, as much as possible. 7. Able and willing to comply with all study procedures. 8. Female subjects 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 subjects 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 at any time during study participation. Key

Exclusion Criteria:

1. Concomitant EG, EoD, or eosinophilic colitis (EC). 2. EG and/or EoD (≥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. 3. Causes of esophageal eosinophilia other than EoE or one the following: hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, or peripheral blood absolute eosinophil count of >1500 eosinophils/μL. 4. History of inflammatory bowel disease, celiac disease, achalasia, and/or esophageal surgery. 5. Any esophageal stricture unable to be passed with a standard diagnostic 9 mm to 10 mm upper endoscope or any critical esophageal stricture that requires dilation during screening. 6. History of bleeding disorders or esophageal varices. 7. 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). All history of malignancy (including diagnosis, dates, and compliance with cancer screening recommendations) must be documented and certified by the Investigator, along with the statement that in their clinical judgment the tissue eosinophilia is attributable to EGID, rather than recurrence of malignancy. 8. Active Helicobacter pylori infection (as determined by central histology staining of the biopsy collected during the Screening EGD), unless treated and confirmed to be negative prior to randomization and symptoms remain consistent. 9. Positive Ova and Parasite (O&P) test at Screening, seropositive for Strongyloides stercoralis at Screening, and/or treatment for a clinically significant helminthic parasitic infection within 6 months of Screening. 10. Seropositive for HIV or hepatitis at Screening, except for vaccinated patients or patients with a history of hepatitis that has since resolved. 11. Prior exposure to AK002 or hypersensitivity to any constituent of AK002. 12. Change in dose of inhaled corticosteroids, nasal corticosteroids, PPI, and/or diet therapy within 4 weeks prior to Screening. 13. Use of oral corticosteroids (swallowed topical or systemic corticosteroids) within 8 weeks prior to Screening. 14. Use of any biologics or medications that may interfere with the study, such as immunosuppressive or immunomodulatory drugs including azathioprine, JAK inhibitors, 6-mercaptopurine, methotrexate, cyclosporine, tacrolimus, anti-TNF, anti-IL-4 receptor, e.g., dupilumab), anti-IL-5 (e.g., mepolizumab), anti-IL-5 receptor (e.g., benralizumab), anti-IL-13 (e.g., lebrikizumab), anti-IgE (e.g., omalizumab), within 12 weeks prior to Screening. 15. Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to administration of study drug or 90 days or 5 half-lives, whichever is longer, for biologic products. 16. Vaccination with live attenuated vaccines ≤30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected ≤5 half-lives (≤4 months) following study drug administration. 17. Treatment with chemotherapy or radiotherapy in the preceding 6 months. 18. Presence of abnormal laboratory values considered by the Investigator to be clinically significant. 19. Any disease, condition (medical or surgical), or cardiac abnormality, which in the opinion of the Investigator, would place the subject at increased risk. 20. Known history of alcohol, drug, or other substance abuse or dependence. 21. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study. 22. 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.

NCT04322708
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 2/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.

Craig Paterson, MD
Principal Investigator Affiliation Allakos Inc.
Agency Class

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

Industry
Overall Status Active, not recruiting
Countries Australia, Netherlands, United States
Conditions

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

Eosinophilic Esophagitis
Arms & Interventions

Arms

Placebo Comparator: Placebo

Subjects in this arm will receive 6 monthly doses of placebo.

Experimental: 1 mg/kg of lirentelimab (AK002)

Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).

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

Other: - Placebo

Placebo

Drug: - lirentelimab (AK002)

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, Birmingham, Alabama

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Allakos Investigational Site

Birmingham, Alabama, 35209

Allakos Investigational Site, Huntsville, Alabama

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Allakos Investigational Site

Huntsville, Alabama, 38801

Allakos Investigational Site, Gilbert, Arizona

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Allakos Investigational Site

Gilbert, Arizona, 85234

Allakos Investigational Site, Phoenix, Arizona

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Allakos Investigational Site

Phoenix, Arizona, 85016

Allakos Investigational Site, Phoenix, Arizona

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Allakos Investigational Site

Phoenix, Arizona, 85021

Allakos Investigational Site, Scottsdale, Arizona

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Allakos Investigational Site

Scottsdale, Arizona, 85251

Allakos Investigational Site, Little Rock, Arkansas

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Allakos Investigational Site

Little Rock, Arkansas, 72205

Allakos Investigational Site, La Jolla, California

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Allakos Investigational Site

La Jolla, California, 92037

Allakos Investigational Site, Los Angeles, California

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Allakos Investigational Site

Los Angeles, California, 90025

Allakos Investigational Site, Oakland, California

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Allakos Investigational Site

Oakland, California, 94612

Allakos Investigational Site, Santa Monica, California

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Allakos Investigational Site

Santa Monica, California, 90404

Allakos Investigational Site, Tustin, California

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Allakos Investigational Site

Tustin, California, 92780

Allakos Investigational Site, Ventura, California

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Allakos Investigational Site

Ventura, California, 93003

Allakos Investigational Site, Walnut Creek, California

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Allakos Investigational Site

Walnut Creek, California, 94598

Allakos Investigational Site, Aurora, Colorado

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Allakos Investigational Site

Aurora, Colorado, 80045

Allakos Investigational Site, Centennial, Colorado

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Allakos Investigational Site

Centennial, Colorado, 80112

Allakos Investigational Site, Brandon, Florida

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Allakos Investigational Site

Brandon, Florida, 33511

Allakos Investigational Site, Edgewater, Florida

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Allakos Investigational Site

Edgewater, Florida, 32132

Allakos Investigational Site, Jacksonville, Florida

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Allakos Investigational Site

Jacksonville, Florida, 32256

Allakos Investigational Site, Miami, Florida

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Allakos Investigational Site

Miami, Florida, 33176

Allakos Investigational Site, Orlando, Florida

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Allakos Investigational Site

Orlando, Florida, 32803

Allakos Investigational Site, Orlando, Florida

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Allakos Investigational Site

Orlando, Florida, 32806

Allakos Investigational Site, Tampa, Florida

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Allakos Investigational Site

Tampa, Florida, 33603

Allakos Investigational Site, Tampa, Florida

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Allakos Investigational Site

Tampa, Florida, 33615

Allakos Investigational Site, Atlanta, Georgia

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Allakos Investigational Site

Atlanta, Georgia, 30342

Allakos Investigational Site, Columbus, Georgia

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Allakos Investigational Site

Columbus, Georgia, 31904

Allakos Investigational Site, Chicago, Illinois

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Allakos Investigational Site

Chicago, Illinois, 60611

Allakos Investigational Site, Indianapolis, Indiana

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Allakos Investigational Site

Indianapolis, Indiana, 46202

Allakos Investigational Site, Iowa City, Iowa

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Allakos Investigational Site

Iowa City, Iowa, 52242

Allakos Investigational Site, Lexington, Kentucky

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Allakos Investigational Site

Lexington, Kentucky, 40503

Allakos Investigational Site, Crowley, Louisiana

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Allakos Investigational Site

Crowley, Louisiana, 70526

Allakos Investigational Site, Chevy Chase, Maryland

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Allakos Investigational Site

Chevy Chase, Maryland, 20815

Allakos Investigational Site, Boston, Massachusetts

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Allakos Investigational Site

Boston, Massachusetts, 02111

Allakos Investigational Site, Boston, Massachusetts

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Allakos Investigational Site

Boston, Massachusetts, 02115

Allakos Investigational Site, Boston, Massachusetts

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Allakos Investigational Site

Boston, Massachusetts, 02215

Allakos Investigational Site, Ann Arbor, Michigan

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Allakos Investigational Site

Ann Arbor, Michigan, 48109

Allakos Investigational Site, Troy, Michigan

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Allakos Investigational Site

Troy, Michigan, 48098

Allakos Investigational Site, Kansas City, Missouri

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Allakos Investigational Site

Kansas City, Missouri, 64108

Allakos Investigational Site, Kalispell, Montana

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Allakos Investigational Site

Kalispell, Montana, 59901

Allakos Investigational Site, Las Vegas, Nevada

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Allakos Investigational Site

Las Vegas, Nevada, 89106

Allakos Investigational Site, Reno, Nevada

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Allakos Investigational Site

Reno, Nevada, 89511

Allakos Investigational Site, Great Neck, New York

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Allakos Investigational Site

Great Neck, New York, 11021

Allakos Investigational Site, New York, New York

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Allakos Investigational Site

New York, New York, 10029

Allakos Investigational Site, Asheville, North Carolina

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Allakos Investigational Site

Asheville, North Carolina, 28801

Allakos Investigational Site, Chapel Hill, North Carolina

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Allakos Investigational Site

Chapel Hill, North Carolina, 27599

Allakos Investigational Site, Charlotte, North Carolina

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Allakos Investigational Site

Charlotte, North Carolina, 28210

Allakos Investigational Site, Charlotte, North Carolina

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Allakos Investigational Site

Charlotte, North Carolina, 28277

Allakos Investigational Site, Durham, North Carolina

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Allakos Investigational Site

Durham, North Carolina, 27710

Allakos Investigational Site, High Point, North Carolina

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Allakos Investigational Site

High Point, North Carolina, 27262

Allakos Investigational Site, Rocky Mount, North Carolina

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Allakos Investigational Site

Rocky Mount, North Carolina, 27804

Allakos Investigational Site, Akron, Ohio

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Allakos Investigational Site

Akron, Ohio, 44302

Allakos Investigational Site, Cincinnati, Ohio

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Allakos Investigational Site

Cincinnati, Ohio, 45229

Allakos Investigational Site, Cincinnati, Ohio

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Allakos Investigational Site

Cincinnati, Ohio, 45231

Allakos Investigational Site, Cleveland, Ohio

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Allakos Investigational Site

Cleveland, Ohio, 44106

Allakos Investigational Site, Dayton, Ohio

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Allakos Investigational Site

Dayton, Ohio, 45415

Allakos Investigational Site, Mentor, Ohio

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Allakos Investigational Site

Mentor, Ohio, 44060

Allakos Investigational Site, Oklahoma City, Oklahoma

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Allakos Investigational Site

Oklahoma City, Oklahoma, 73112

Allakos Investigational Site, Danville, Pennsylvania

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Allakos Investigational Site

Danville, Pennsylvania, 17822

Allakos Investigational Site, Philadelphia, Pennsylvania

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Allakos Investigational Site

Philadelphia, Pennsylvania, 19104

Allakos Investigational Site, Greenville, South Carolina

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Allakos Investigational Site

Greenville, South Carolina, 29615

Allakos Investigational Site, Chattanooga, Tennessee

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Allakos Investigational Site

Chattanooga, Tennessee, 37421

Allakos Investigational Site, Hixson, Tennessee

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Allakos Investigational Site

Hixson, Tennessee, 37343

Allakos Investigational Site, Nashville, Tennessee

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Allakos Investigational Site

Nashville, Tennessee, 37212

Allakos Investigational Site, Austin, Texas

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Allakos Investigational Site

Austin, Texas, 78704

Allakos Investigational Site, Garland, Texas

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Allakos Investigational Site

Garland, Texas, 75044

Allakos Investigational Site, San Antonio, Texas

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Allakos Investigational Site

San Antonio, Texas, 78229

Allakos Investigational Site, Ogden, Utah

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Allakos Investigational Site

Ogden, Utah, 84405

Allakos Investigational Site, Riverton, Utah

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Allakos Investigational Site

Riverton, Utah, 84065

Allakos Investigational Site, Salt Lake City, Utah

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Allakos Investigational Site

Salt Lake City, Utah, 84132

Allakos Investigational Site, Sandy, Utah

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Allakos Investigational Site

Sandy, Utah, 84092

Allakos Investigational Site, Leesburg, Virginia

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Allakos Investigational Site

Leesburg, Virginia, 20176

Allakos Investigational Site, Seattle, Washington

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Allakos Investigational Site

Seattle, Washington, 98105

Allakos Investigational Site, Seattle, Washington

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Allakos Investigational Site

Seattle, Washington, 98115

International Sites

Allakos Investigational Site, Adelaide, South Australia, Australia

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Allakos Investigational Site

Adelaide, South Australia, 5000

Allakos Investigational Site, Elizabeth Vale, South Australia, Australia

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Allakos Investigational Site

Elizabeth Vale, South Australia, 5112

Allakos Investigational Site, Box Hill, Victoria, Australia

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Allakos Investigational Site

Box Hill, Victoria, 3128

Allakos Investigational Site, Prahran, Victoria, Australia

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Allakos Investigational Site

Prahran, Victoria, 3181

Allakos Investigational Site, Amsterdam, North Holland, Netherlands

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Allakos Investigational Site

Amsterdam, North Holland, 1105 AZ

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