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

Primary Purpose

Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophilic Duodenitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AK002
Sponsored by
Allakos Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Gastritis focused on measuring Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophil, EG, EGE, EGID, Eosinophilic gastrointestinal disorders, Eosinophilic Duodenitis, EoD

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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 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.

Sites / Locations

  • Phoenician Centers for Research and Innovation
  • Mayo Clinic Arizona
  • Ventura Clinical Trials
  • Advanced Research Institute
  • Northwestern
  • University of Iowa
  • NIH
  • Tufts Medical Center
  • Mayo Clinic
  • Mount Sinai
  • University of North Carolina - Chapel Hill
  • Cincinnati Children's Hospital
  • University of Pennsylvania
  • ClinSearch
  • Vanderbilt University
  • Avant Research Associates
  • University of Utah

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1 to 3.0 mg/kg of AK002

Arm Description

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

Outcomes

Primary Outcome Measures

The safety and tolerability of AK002 by evaluating adverse events assessed using the CTCAE version 4.03
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
Evaluation of symptoms of EG and/or EoD (formerly referred to as EGE) using a daily disease-specific patient questionnaire (PRO Questionnaire)
Changes in the number of eosinophils in gastric and/or duodenal mucosa

Secondary Outcome Measures

Full Information

First Posted
September 6, 2018
Last Updated
March 30, 2023
Sponsor
Allakos Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03664960
Brief Title
An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis
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 Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 14, 2018 (Actual)
Primary Completion Date
November 2, 2021 (Actual)
Study Completion Date
November 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allakos Inc.

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophilic Duodenitis
Keywords
Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophil, EG, EGE, EGID, Eosinophilic gastrointestinal disorders, Eosinophilic Duodenitis, EoD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 to 3.0 mg/kg of AK002
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
AK002
Intervention Description
AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
Primary Outcome Measure Information:
Title
The safety and tolerability of AK002 by evaluating adverse events assessed using the CTCAE version 4.03
Time Frame
Day 785 (End of Study)
Title
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 785 (End of Study)
Title
Evaluation of symptoms of EG and/or EoD (formerly referred to as EGE) using a daily disease-specific patient questionnaire (PRO Questionnaire)
Time Frame
Baseline to Day 785 (End of Study)
Title
Changes in the number of eosinophils in gastric and/or duodenal mucosa
Time Frame
Baseline to Day 729

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 and willing to begin extended dosing on or about Day 113. 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. Planned or expected vaccination with live attenuated vaccines during the treatment, or vaccination expected within 5 half-lives (4 months) of AK002 administration. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Paterson, MD
Organizational Affiliation
Allakos Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Phoenician Centers for Research and Innovation
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85021
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Ventura Clinical Trials
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Advanced Research Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Northwestern
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
NIH
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
ClinSearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Avant Research Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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