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

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ClinicalTrials.gov Identifier: NCT03664960
Recruitment Status : Enrolling by invitation
First Posted : September 11, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Allakos, Inc.

Brief Summary:
This is a Phase 2, open-label, extension study to assess the safety and tolerability of AK002, given monthly for 8 doses.

Condition or disease Intervention/treatment Phase
Eosinophilic Gastritis Eosinophilic Gastroenteritis Drug: AK002 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Safety and Tolerability of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 0.3 to 3.0 mg/kg of AK002
Subjects in this arm will receive 8 monthly doses of AK002: a first dose of 0.3 mg/kg, followed by monthly doses of up to 3 mg/kg
Drug: AK002
AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).




Primary Outcome Measures :
  1. The safety and tolerability of AK002 by evaluating adverse events assessed using the CTCAE version 4.03 [ Time Frame: Day 1 to Day 225 (End of Study) ]
  2. The safety and tolerability of AK002 as assessed by symptom-directed physical examination of reported or observed patient symptoms warranting examination, including assessments of possible infusion site reactions and infusion-related reactions [ Time Frame: Day 1 to Day 225 (End of Study) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664960


Locations
United States, Arizona
Phoenician Centers for Research and Innovation
Phoenix, Arizona, United States, 85021
United States, Florida
Riverside Clinical Research
Edgewater, Florida, United States, 32132
United States, Illinois
Northwestern
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37212
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Allakos, Inc.
Investigators
Study Director: Henrik Rasmussen, MD, PhD Allakos, Inc.

Responsible Party: Allakos, Inc.
ClinicalTrials.gov Identifier: NCT03664960     History of Changes
Other Study ID Numbers: AK002-003X
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Allakos, Inc.:
Eosinophilic Gastritis
Eosinophilic Gastroenteritis
Eosinophil
EG
EGE
EGID
Eosinophilic gastrointestinal disorders

Additional relevant MeSH terms:
Gastroenteritis
Gastritis
Eosinophilic Esophagitis
Enteritis
Eosinophilia
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esophagitis
Esophageal Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Intestinal Diseases