A Study to Assess Subcutaneous AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis
NCT ID: NCT05152563
Last Updated: 2023-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2021-12-31
2022-01-20
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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SC 150 mg of lirentelimab (AK002)
Subjects in this arm will receive 6 monthly doses of 150 mg of lirentelimab (AK002) administered subcutaneously.
AK002
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1) monoclonal antibody directed against Siglec-8
SC 300 mg of lirentelimab (AK002)
Subjects in this arm will receive 6 monthly doses of 300 mg of lirentelimab (AK002) administered subcutaneously.
AK002
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1) monoclonal antibody directed against Siglec-8
SC 450 mg of lirentelimab (AK002)
Subjects in this arm will receive 6 monthly doses of 450 mg of lirentelimab (AK002) administered subcutaneously.
AK002
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1) monoclonal antibody directed against Siglec-8
Placebo
Placebo
Placebo
Placebo
Interventions
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AK002
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1) monoclonal antibody directed against Siglec-8
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 at least 5 hpf in the stomach and/or ≥30 eosinophils/hpf in at least 3 hpf in the duodenum as determined by central histology assessment of biopsies collected during the screening EGD without any other significant cause for the eosinophilia.
4. Completion of at least 4 daily PRO questionnaires per week for a minimum of 3 weeks during screening.
5. A weekly average score of abdominal pain, nausea, or diarrhea ≥3 on the PRO questionnaire (score from 0-10) and a weekly average TSS of ≥10 for at least 2 weeks of screening.
6. Subjects with inadequate or loss of response to, or who were intolerant to standard therapies for EG and/or EoD, which could include PPI, antihistamines, systemic or topical corticosteroids, and/or diet, among others.
7. If subject is on preexisting dietary restrictions, willingness to maintain dietary restrictions throughout the study.
8. Willing and able to comply with all study procedures and visit schedule including follow-up visits.
9. 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 (e.g., missed or late menstrual period) at any time during study participation.
Exclusion Criteria
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 Heliobacter pylori (H. pylori) infection as confirmed by stool antigen test for H. pylori or identified in tissue biopsies obtained at screening EGD.
6. History of inflammatory bowel disease, celiac disease, achalasia, or esophageal surgery.
7. History of bleeding disorders and/or esophageal varices considered to be clinically significant by the Investigator.
8. Other significant 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 subject at increased risk.
13. History of malignancy, except carcinoma in situ, early-stage prostate cancer, or non-melanoma skin cancers. However, subjects with cancers that have been in remission for more than 5 years and are considered cured can be enrolled.
14. Treatment for a clinically significant helminthic parasitic infection within 6 months of screening.
15. Positive helminthic infection on Ova and Parasite (O\&P) test.
16. Seropositive for Strongyloides stercoralis at screening.
17. Seropositive for HIV or hepatitis at screening except for vaccinated subjects or subjects with past but resolved hepatitis at screening.
18. Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study or expected during the treatment period. Vaccines authorized by FDA or other regulatory authority for the prevention of COVID-19 may be administered before, during, or after this protocol as per the label. The vaccine should not be administered within 7 days prior to and within 7 days after the administration of AK002 so that the side effects caused by either of the 2 medications can be more easily determined.
19. 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).
20. Known history of alcohol, drug, or other substance abuse or dependence that is considered by the Investigator to be ongoing and clinically significant.
21. Any other reason that in the opinion of the Investigator or the Medical Monitor makes the subject unsuitable for enrollment.
18 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
Gilbert, Arizona, United States
Allakos Investigational Site
Phoenix, Arizona, United States
Allakos Investigational Site
Scottsdale, Arizona, United States
Allakos Investigational Site
Chula Vista, California, United States
Allakos Investigational Site
Long Beach, California, United States
Allakos Investigational Site
Ventura, California, United States
Allakos Investigational Site
Walnut Creek, California, United States
Allakos Investigational Site
Bristol, Connecticut, 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
Kissimmee, Florida, United States
Allakos Investigational Site
Miami, Florida, United States
Allakos Investigational Site
New Port Richey, Florida, United States
Allakos Investigational Site
Ponte Vedra, Florida, United States
Allakos Investigational Site
Sunrise, 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
Sandy Springs, Georgia, United States
Allakos Investigational Site
Chicago, Illinois, United States
Allakos Investigational Site
Iowa City, Iowa, United States
Allakos Investigational Site
Kansas City, Kansas, United States
Allakos Investigational Site
Crowley, Louisiana, United States
Allakos Investigational Site
Shreveport, Louisiana, United States
Allakos Investigational Site
Glen Burnie, Maryland, United States
Allakos Investigational Site
Boston, Massachusetts, United States
Allakos Investigational Site
Boston, Massachusetts, United States
Allakos Investigational Site
Ann Arbor, Michigan, United States
Allakos Investigational Site
Wyoming, Michigan, United States
Allakos Investigational Site
Rochester, Minnesota, United States
Allakos Investigational Site
Bay Saint Louis, Mississippi, United States
Allakos Investigational Site
Flowood, Mississippi, United States
Allakos Investigational Site
Kansas City, Missouri, United States
Allakos Investigational Site
Kalispell, Montana, United States
Allakos Investigational Site
Reno, Nevada, United States
Allakos Investigational Site
Lebanon, New Hampshire, United States
Allakos Investigational Site
Florham Park, New Jersey, United States
Allakos Investigational Site
Freehold, New Jersey, United States
Allakos Investigational Site
Great Neck, New York, United States
Allakos Investigational Site
New York, New York, United States
Allakos Investigational Site
Chapel Hill, North Carolina, United States
Allakos Investigational Site
Charlotte, North Carolina, United States
Allakos Investigational Site
Concord, North Carolina, United States
Allakos Investigational Site
Durham, North Carolina, United States
Allakos Investigational Site
Raleigh, North Carolina, United States
Allakos Investigational Site
Winston-Salem, North Carolina, United States
Allakos Investigational Site
Cincinnati, Ohio, United States
Allakos Investigational Site
Columbus, Ohio, United States
Allakos Investigational Site
Dayton, Ohio, United States
Allakos Investigational Site
Mentor, Ohio, United States
Allakos Investigational Site
Springboro, Ohio, United States
Allakos Investigational Site
Westlake, Ohio, United States
Allakos Investigational Site
Oklahoma City, Oklahoma, United States
Allakos Investigational Site
Philadelphia, Pennsylvania, United States
Allakos Investigational Site
Greenwood, South Carolina, United States
Allakos Investigational Site
Chattanooga, Tennessee, United States
Allakos Investigational Site
Germantown, 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
El Paso, Texas, United States
Allakos Investigational Site
Fort Worth, Texas, United States
Allakos Investigational Site
Lubbock, Texas, United States
Allakos Investigational Site
San Antonio, Texas, United States
Allakos Investigational Site
Southlake, Texas, United States
Allakos Investigational Site
Webster, Texas, United States
Allakos Investigational Site
Wichita Falls, 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
Fairfax, Virginia, United States
Allakos Investigational Site
Seattle, Washington, United States
Allakos Investigational Site
Seattle, Washington, United States
Countries
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Other Identifiers
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AK002-023
Identifier Type: -
Identifier Source: org_study_id
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