An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
NCT ID: NCT04620811
Last Updated: 2024-04-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
159 participants
INTERVENTIONAL
2020-12-03
2023-07-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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3.0 mg/kg of Lirentelimab (AK002)
Subjects in this arm will receive up to 18 monthly doses (3mg/kg) of lirentelimab (AK002)
lirentelimab
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8
Interventions
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lirentelimab
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Completed Study AK002-016, defined as having received 6 infusions of study drug and followed through Day 176 (±3) or completed Study AK002-012, defined as having received the cohort-appropriate amount of doses and followed for 5 months after last dose of study drug.
3. If patient is on pre-existing dietary restrictions, willingness to maintain those restrictions, throughout the study.
4. Able and willing to comply with all study procedures.
5. Female patients must be either post-menopausal for at least 1 year 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 until the end of the study, or for 120 days following the last dose of study drug, whichever is longer.
6. Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception 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. Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.
3. Planned or expected vaccination with live attenuated vaccines during the Treatment Period, or vaccination expected within 5 half-lives (4 months) of AK002 administration.
4. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
5. Any other reason that, in the opinion of the Investigator or Medical Monitor, makes the patient 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 Patterson, MD
Role: STUDY_DIRECTOR
Allakos Inc.
Locations
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Allakos Investigational Site 216-068
Birmingham, Alabama, United States
Allakos Investigational Site 216-002
Huntsville, Alabama, United States
Allakos Investigational Site 216-035
Phoenix, Arizona, United States
Allakos Investigational Site 216-032
Chula Vista, California, United States
Allakos Investigational Site 216-014
Santa Monica, California, United States
Allakos Investigational Site 216-038
Tustin, California, United States
Allakos Investigational Site 216-049
Walnut Creek, California, United States
Allakos Investigational Site 216-034
Aurora, Colorado, United States
Allakos Investigational Site 216-063
Brandon, Florida, United States
Allakos Investigational Site 216-027
Edgewater, Florida, United States
Allakos Investigational Site 216-056
Jacksonville, Florida, United States
Allakos Investigational Site 216-013
Miami, Florida, United States
Allakos Investigational Site 216-053
New Port Richey, Florida, United States
Allakos Investigational Site 216-007
Chicago, Illinois, United States
Allakos Investigational Site 216-001
Crowley, Louisiana, United States
Allakos Investigational Site 216-026
Boston, Massachusetts, United States
Allakos Investigational Site 216-052
Boston, Massachusetts, United States
Allakos Investigational Site 216-051
Boston, Massachusetts, United States
Allakos Investigational Site 216-005
Rochester, Minnesota, United States
Allakos Investigational Site 216-042
Kansas City, Missouri, United States
Allakos Investigational Site 216-045
Reno, Nevada, United States
Allakos Investigational Site 216-025
New York, New York, United States
Allakos Investigational Site 216-020
Chapel Hill, North Carolina, United States
Allakos Investigational Site 216-048
Durham, North Carolina, United States
Allakos Investigational Site 216-050
Winston-Salem, North Carolina, United States
Allakos Investigational Site 216-031
Cincinnati, Ohio, United States
Allakos Investigational Site 216-028
Cincinnati, Ohio, United States
Allakos Investigational Site 216-044
Mentor, Ohio, United States
Allakos Investigational Site 216-021
Philadelphia, Pennsylvania, United States
Allakos Investigational Site 216-006
Chattanooga, Tennessee, United States
Allakos Investigational Site 216-003
Chattanooga, Tennessee, United States
Allakos Investigational Site 216-011
Chattanooga, Tennessee, United States
Allakos Investigational Site 216-062
Kingsport, Tennessee, United States
Allakos Investigational Site 216-022
Austin, Texas, United States
Allakos Investigational Site 216-039
Ogden, Utah, United States
Allakos Investigational Site 216-030
Salt Lake City, Utah, United States
Allakos Investigational Site 216-055
Sandy City, Utah, United States
Allakos Investigational Site 216-064
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AK002-016X
Identifier Type: -
Identifier Source: org_study_id
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