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A Study of Antolimab (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 antolimab (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 antolimab (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.

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 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 antolimab (AK002)

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

Experimental: 3 mg/kg of antolimab (AK002)

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

Interventions

Other: - Placebo

Placebo

Drug: - antolimab (AK002)

Antolimab (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, 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

Not yet recruiting

Address

Allakos Investigational Site

Gilbert, Arizona, 85234

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Phoenix, Arizona

Status

Recruiting

Address

Allakos Investigational Site

Phoenix, Arizona, 85016

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Scottsdale, Arizona

Status

Not yet 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, 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

Not yet 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

Not yet 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, 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

Not yet 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

Not yet recruiting

Address

Allakos Investigational Site

Miami, Florida, 33176

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Orlando, Florida

Status

Not yet recruiting

Address

Allakos Investigational Site

Orlando, Florida, 32806

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Atlanta, Georgia

Status

Not yet recruiting

Address

Allakos Investigational Site

Atlanta, Georgia, 30342

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Columbus, Georgia

Status

Not yet recruiting

Address

Allakos Investigational Site

Columbus, Georgia, 31904

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, Iowa City, Iowa

Status

Not yet recruiting

Address

Allakos Investigational Site

Iowa City, Iowa, 52242

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Lexington, Kentucky

Status

Not yet recruiting

Address

Allakos Investigational Site

Lexington, Kentucky, 40503

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

Not yet 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, 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, Kansas City, Missouri

Status

Not yet recruiting

Address

Allakos Investigational Site

Kansas City, Missouri, 64108

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Reno, Nevada

Status

Not yet 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

Not yet 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

Not yet recruiting

Address

Allakos Investigational Site

New York, New York, 10029

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Asheville, North Carolina

Status

Not yet recruiting

Address

Allakos Investigational Site

Asheville, North Carolina, 28801

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Chapel Hill, North Carolina

Status

Not yet 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, Charlotte, North Carolina

Status

Not yet recruiting

Address

Allakos Investigational Site

Charlotte, North Carolina, 28277

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Durham, North Carolina

Status

Not yet 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, Akron, Ohio

Status

Not yet recruiting

Address

Allakos Investigational Site

Akron, Ohio, 44308

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Cincinnati, Ohio

Status

Not yet 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

Not yet 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

Not yet recruiting

Address

Allakos Investigational Site

Philadelphia, Pennsylvania, 19104

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Greenville, South Carolina

Status

Not yet recruiting

Address

Allakos Investigational Site

Greenville, South Carolina, 29615

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Chattanooga, Tennessee

Status

Not yet 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, Nashville, Tennessee

Status

Not yet 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

Not yet recruiting

Address

Allakos Investigational Site

Austin, Texas, 78704

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Garland, Texas

Status

Not yet recruiting

Address

Allakos Investigational Site

Garland, Texas, 75044

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, Salt Lake City, Utah

Status

Not yet recruiting

Address

Allakos Investigational Site

Salt Lake City, Utah, 84132

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

International Sites

Allakos Investigational Site, Adelaide, South Australia, Australia

Status

Not yet recruiting

Address

Allakos Investigational Site

Adelaide, South Australia, 5128

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Box Hill, Victoria, Australia

Status

Not yet recruiting

Address

Allakos Investigational Site

Box Hill, Victoria, 3128

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

Allakos Investigational Site, Amsterdam, North Holland, Netherlands

Status

Not yet recruiting

Address

Allakos Investigational Site

Amsterdam, North Holland, 1105 AZ

Site Contact

Central Contact Person

hrasmussen@allakos.com

443-699-5230

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