An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis

Study Purpose

This is a Phase 2, open-label, extension study to assess the safety and tolerability of AK002, given monthly for up to 26 doses.

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	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Provide written informed consent. 2. Completed Study AK002-003, defined as having received 4 infusions of study drug and followed through Day 113 (±3 days) in Study AK002-003 and willing to begin extended dosing on or about Day 113. 3. Able and willing to comply with all study procedures. 4. 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. 5. 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:

1. Poor tolerance to previous administration of AK002 in the opinion of the Investigator. 2. Known hypersensitivity to any constituent of the study drug. 3. Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk. 4. Planned or expected vaccination with live attenuated vaccines during the treatment, or vaccination expected within 5 half-lives (4 months) of AK002 administration. 5. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study. 6. 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.	NCT03664960
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
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	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophilic Duodenitis

Arms & Interventions

Arms

Experimental: 1 to 3.0 mg/kg of AK002

Subjects in this arm will receive 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg

Interventions

Drug: - AK002

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.

Phoenix, Arizona

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Phoenician Centers for Research and Innovation

Phoenix, Arizona, 85021

Mayo Clinic Arizona, Scottsdale, Arizona

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Mayo Clinic Arizona

Scottsdale, Arizona, 85259

Ventura Clinical Trials, Ventura, California

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Ventura Clinical Trials

Ventura, California, 93003

Advanced Research Institute, New Port Richey, Florida

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Advanced Research Institute

New Port Richey, Florida, 34653

Northwestern, Chicago, Illinois

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Northwestern

Chicago, Illinois, 60611

University of Iowa, Iowa City, Iowa

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University of Iowa

Iowa City, Iowa, 52242

NIH, Bethesda, Maryland

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NIH

Bethesda, Maryland, 20892

Tufts Medical Center, Boston, Massachusetts

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Tufts Medical Center

Boston, Massachusetts, 02111

Mayo Clinic, Rochester, Minnesota

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Mayo Clinic

Rochester, Minnesota, 55905

Mount Sinai, New York, New York

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Mount Sinai

New York, New York, 10029

Chapel Hill, North Carolina

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University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599

Cincinnati Children's Hospital, Cincinnati, Ohio

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Cincinnati Children's Hospital

Cincinnati, Ohio, 45229

University of Pennsylvania, Philadelphia, Pennsylvania

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University of Pennsylvania

Philadelphia, Pennsylvania, 19104

ClinSearch, Chattanooga, Tennessee

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ClinSearch

Chattanooga, Tennessee, 37421

Vanderbilt University, Nashville, Tennessee

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Vanderbilt University

Nashville, Tennessee, 37212

Avant Research Associates, Austin, Texas

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Avant Research Associates

Austin, Texas, 78704

University of Utah, Salt Lake City, Utah

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Address

University of Utah

Salt Lake City, Utah, 84132

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