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An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Safety and Tolerability of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

NCT03664960•Allakos Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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 or discontinued from treatment due to high eosinophil counts prior to infusions 2, 3, or 4 and willing to begin extended dosing on or about Day 113 (for AK002-003 completers) or within 6 months of last dosing for patients discontinued from treatment.
•3. If patient is on pre-existing dietary restrictions, willingness to note any changes that occur from the Baseline diet, 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

•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. Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives (4 months) of study drug administration. All types and formulations of vaccines (including live attenuated vaccines) authorized by FDA or other regulatory authority for the prevention of COVID-19 may be administered before, during, or after this study. The vaccine should not be administered within 7 days prior to and within 7 days after the administration of AK002 so that any side effects caused by either of the 2 medications can be more easily determined.
•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.
•7. Diagnosis of Hypereosinophilic Syndrome (HES), based on standard criteria (blood eosinophils \>1500/µL with involvement of either the heart, nervous system, and/or bone marrow).

Locations (17)

Phoenician Centers for Research and Innovation

Phoenix, Arizona, United States

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Ventura Clinical Trials

Ventura, California, United States

Advanced Research Institute

New Port Richey, Florida, United States

Northwestern

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

NIH

Bethesda, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Mount Sinai

New York, New York, United States

Key Dates

Start Date

November 14, 2018

Primary Completion Date

November 2, 2021

Completion Date

November 2, 2021

Last Updated

February 28, 2024

Enrollment

ACTUAL participants

Conditions

Eosinophilic GastritisEosinophilic GastroenteritisEosinophilic Duodenitis

Interventions

AK002

DRUG

Eosinophilic Gastrointestinal Disorders Registry

NCT05199532

Eosinophilic EsophagitisEosinophilic Gastroenteritis+2 more

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COMPLETEDPHASE4

Examining the Effect of Ondansetron on Bowel Prep Success

NCT05439772

Abdominal PainInflammatory Bowel Diseases+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Eosinophilic Gastrointestinal Disorders Registry

Examining the Effect of Ondansetron on Bowel Prep Success

Immunopathogenesis of Food Allergy and Eosinophilic Gastrointestinal Disorders