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

Phase 2

Completed

Conditions: Eosinophilic Gastritis
Eosinophilic Gastroenteritis
Eosinophilic Duodenitis

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Provide written informed consent.
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.
If patient is on pre-existing dietary restrictions, willingness to note any changes that occur from the Baseline diet, throughout the study.
Able and willing to comply with all study procedures.
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.
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

Poor tolerance to previous administration of AK002 in the opinion of the Investigator.
Known hypersensitivity to any constituent of the study drug.
Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.
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.
Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
Any other reason that, in the opinion of the Investigator or Medical Monitor, makes the patient unsuitable for enrollment.
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).

Arm && Interventions

Group	Intervention	Description
1 to 3.0 mg/kg of AK002	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

Primary Outcome Measures

Name	Time	Method
The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03	Through study completion, up to 28 months	Adverse events assessed using the CTCAE version 4.03

Secondary Outcome Measures

Name	Time	Method
Percent Change in PRO Total Symptom Score (TSS) From AK002-003 Baseline	AK002-003 Baseline to End of Treatment (2 weeks post last dose, up to 26 months)	The PRO Total Symptom Score (TSS) is a patient-reported outcome (PRO) questionnaire comprises the following 8 symptoms: abdominal pain, nausea, vomiting, early satiety, loss of appetite, abdominal cramping, bloating, and diarrhea. Individual symptom scores ranged from 0 to 10. The daily total symptom score ranged from 0 to 80, with higher scores indicating greater severity. The End of treatment TSS score is defined as the average of the 14 daily scores on or after the day of the last dose of the extension study.
Changes in the Number of Eosinophils in Gastric and/or Duodenal Mucosa From AK002-003 Baseline	AK002-003 Baseline to Day 547	Percentage of Change in the Number of Eosinophils in Gastric and/or Duodenal Mucosa in each group from AK002-003 Baseline

Locations (17): Tufts Medical Center
🇺🇸
Boston, Massachusetts, United States
Cincinnati Children's Hospital
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Cincinnati, Ohio, United States
Vanderbilt University
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Nashville, Tennessee, United States
University of Utah
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Salt Lake City, Utah, United States
University of Pennsylvania
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Philadelphia, Pennsylvania, United States
Ventura Clinical Trials
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Ventura, California, United States
University of Iowa
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Iowa City, Iowa, United States
Phoenician Centers for Research and Innovation
🇺🇸
Phoenix, Arizona, United States
Mayo Clinic
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Rochester, Minnesota, United States
Mayo Clinic Arizona
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Scottsdale, Arizona, United States
Advanced Research Institute
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New Port Richey, Florida, United States
Northwestern
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Chicago, Illinois, United States
NIH
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Bethesda, Maryland, United States
ClinSearch
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Chattanooga, Tennessee, United States
Mount Sinai
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New York, New York, United States
University of North Carolina - Chapel Hill
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Chapel Hill, North Carolina, United States
Avant Research Associates
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Austin, Texas, United States