A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis
NCT ID: NCT04322708
Last Updated: 2024-01-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
277 participants
INTERVENTIONAL
2020-07-06
2022-01-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Subjects in this arm will receive 6 monthly doses of placebo.
Placebo
Placebo
1 mg/kg of lirentelimab (AK002)
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).
lirentelimab (AK002)
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
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.
lirentelimab (AK002)
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
Interventions
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Placebo
Placebo
lirentelimab (AK002)
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
12 Years
80 Years
ALL
No
Sponsors
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Allakos Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Craig Paterson, MD
Role: STUDY_DIRECTOR
Allakos Inc.
Locations
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Allakos Investigational Site
Birmingham, Alabama, United States
Allakos Investigational Site
Huntsville, Alabama, United States
Allakos Investigational Site
Gilbert, Arizona, United States
Allakos Investigational Site
Phoenix, Arizona, United States
Allakos Investigational Site
Phoenix, Arizona, United States
Allakos Investigational Site
Scottsdale, Arizona, United States
Allakos Investigational Site
Little Rock, Arkansas, United States
Allakos Investigational Site
La Jolla, California, United States
Allakos Investigational Site
Los Angeles, California, United States
Allakos Investigational Site
Oakland, California, United States
Allakos Investigational Site
Santa Monica, California, United States
Allakos Investigational Site
Tustin, California, United States
Allakos Investigational Site
Ventura, California, United States
Allakos Investigational Site
Walnut Creek, California, United States
Allakos Investigational Site
Aurora, Colorado, United States
Allakos Investigational Site
Centennial, Colorado, United States
Allakos Investigational Site
Brandon, Florida, United States
Allakos Investigational Site
Edgewater, Florida, United States
Allakos Investigational Site
Jacksonville, Florida, United States
Allakos Investigational Site
Miami, Florida, United States
Allakos Investigational Site
Orlando, Florida, United States
Allakos Investigational Site
Orlando, Florida, United States
Allakos Investigational Site
Tampa, Florida, United States
Allakos Investigational Site
Tampa, Florida, United States
Allakos Investigational Site
Atlanta, Georgia, United States
Allakos Investigational Site
Columbus, Georgia, United States
Allakos Investigational Site
Chicago, Illinois, United States
Allakos Investigational Site
Indianapolis, Indiana, United States
Allakos Investigational Site
Iowa City, Iowa, United States
Allakos Investigational Site
Lexington, Kentucky, United States
Allakos Investigational Site
Crowley, Louisiana, United States
Allakos Investigational Site
Chevy Chase, Maryland, United States
Allakos Investigational Site
Boston, Massachusetts, United States
Allakos Investigational Site
Boston, Massachusetts, United States
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Boston, Massachusetts, United States
Allakos Investigational Site
Ann Arbor, Michigan, United States
Allakos Investigational Site
Troy, Michigan, United States
Allakos Investigational Site
Kansas City, Missouri, United States
Allakos Investigational Site
Kalispell, Montana, United States
Allakos Investigational Site
Las Vegas, Nevada, United States
Allakos Investigational Site
Reno, Nevada, United States
Allakos Investigational Site
Great Neck, New York, United States
Allakos Investigational Site
New York, New York, United States
Allakos Investigational Site
Asheville, North Carolina, United States
Allakos Investigational Site
Chapel Hill, North Carolina, United States
Allakos Investigational Site
Charlotte, North Carolina, United States
Allakos Investigational Site
Charlotte, North Carolina, United States
Allakos Investigational Site
Durham, North Carolina, United States
Allakos Investigational Site
High Point, North Carolina, United States
Allakos Investigational Site
Rocky Mount, North Carolina, United States
Allakos Investigational Site
Akron, Ohio, United States
Allakos Investigational Site
Cincinnati, Ohio, United States
Allakos Investigational Site
Cincinnati, Ohio, United States
Allakos Investigational Site
Cleveland, Ohio, United States
Allakos Investigational Site
Dayton, Ohio, United States
Allakos Investigational Site
Mentor, Ohio, United States
Allakos Investigational Site
Oklahoma City, Oklahoma, United States
Allakos Investigational Site
Danville, Pennsylvania, United States
Allakos Investigational Site
Philadelphia, Pennsylvania, United States
Allakos Investigational Site
Greenville, South Carolina, United States
Allakos Investigational Site
Chattanooga, Tennessee, United States
Allakos Investigational Site
Hixson, Tennessee, United States
Allakos Investigational Site
Nashville, Tennessee, United States
Allakos Investigational Site
Austin, Texas, United States
Allakos Investigational Site
Garland, Texas, United States
Allakos Investigational Site
San Antonio, Texas, United States
Allakos Investigational Site
Ogden, Utah, United States
Allakos Investigational Site
Riverton, Utah, United States
Allakos Investigational Site
Salt Lake City, Utah, United States
Allakos Investigational Site
Sandy City, Utah, United States
Allakos Investigational Site
Leesburg, Virginia, United States
Allakos Investigational Site
Seattle, Washington, United States
Allakos Investigational Site
Seattle, Washington, United States
Allakos Investigational Site
Adelaide, South Australia, Australia
Allakos Investigational Site
Elizabeth Vale, South Australia, Australia
Allakos Investigational Site
Box Hill, Victoria, Australia
Allakos Investigational Site
Prahran, Victoria, Australia
Allakos Investigational Site
Amsterdam, North Holland, Netherlands
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AK002-014
Identifier Type: -
Identifier Source: org_study_id
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