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

Completed · Phase 2

Conditions studied: Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophilic Duodenitis

In brief

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

Key facts

Study ID

NCT03664960

Run by

Allakos Inc.

People needed

58

Starts

2018-11-14

Expected to finish

2021-11-02

Last updated by the study team

2024-02-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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
• University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• ClinSearch — Chattanooga, Tennessee, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Avant Research Associates — Austin, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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