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An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

Primary Purpose

Eosinophilic Gastritis, Eosinophilic Duodenitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
lirentelimab
Sponsored by
Allakos Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Gastritis

Eligibility Criteria

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

Key Inclusion Criteria:

  1. Provide written informed consent.
  2. Completed Study AK002-016, defined as having received 6 infusions of study drug and followed through Day 176 (±3) or completed Study AK002-012, defined as having received the cohort-appropriate amount of doses and followed for 5 months after last dose of study drug.
  3. If patient is on pre-existing dietary restrictions, willingness to maintain those restrictions, 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.

Key Exclusion Criteria:

  1. Known hypersensitivity to any constituent of the study drug.
  2. Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.
  3. Planned or expected vaccination with live attenuated vaccines during the Treatment Period, or vaccination expected within 5 half-lives (4 months) of AK002 administration.
  4. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
  5. Any other reason that, in the opinion of the Investigator or Medical Monitor, makes the patient unsuitable for enrollment.

Sites / Locations

  • Allakos Investigational Site 216-068
  • Allakos Investigational Site 216-002
  • Allakos Investigational Site 216-035
  • Allakos Investigational Site 216-032
  • Allakos Investigational Site 216-014
  • Allakos Investigational Site 216-038
  • Allakos Investigational Site 216-049
  • Allakos Investigational Site 216-034
  • Allakos Investigational Site 216-063
  • Allakos Investigational Site 216-027
  • Allakos Investigational Site 216-056
  • Allakos Investigational Site 216-013
  • Allakos Investigational Site 216-053
  • Allakos Investigational Site 216-007
  • Allakos Investigational Site 216-001
  • Allakos Investigational Site 216-026
  • Allakos Investigational Site 216-052
  • Allakos Investigational Site 216-051
  • Allakos Investigational Site 216-005
  • Allakos Investigational Site 216-042
  • Allakos Investigational Site 216-045
  • Allakos Investigational Site 216-025
  • Allakos Investigational Site 216-020
  • Allakos Investigational Site 216-048
  • Allakos Investigational Site 216-050
  • Allakos Investigational Site 216-031
  • Allakos Investigational Site 216-028
  • Allakos Investigational Site 216-044
  • Allakos Investigational Site 216-021
  • Allakos Investigational Site 216-006
  • Allakos Investigational Site 216-003
  • Allakos Investigational Site 216-011
  • Allakos Investigational Site 216-062
  • Allakos Investigational Site 216-022
  • Allakos Investigational Site 216-039
  • Allakos Investigational Site 216-030
  • Allakos Investigational Site 216-055
  • Allakos Investigational Site 216-064

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3.0 mg/kg of Lirentelimab (AK002)

Arm Description

Subjects in this arm will receive up to 18 monthly doses (3mg/kg) of lirentelimab (AK002)

Outcomes

Primary Outcome Measures

The safety and tolerability of lirentelimab by evaluating adverse events assessed using the CTCAE version 5.0
The safety and tolerability of lirentelimab 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 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
November 3, 2020
Last Updated
September 14, 2023
Sponsor
Allakos Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04620811
Brief Title
An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
Official Title
A Phase 3, Multicenter, Open-Label, Extension Study to Evaluate the Efficacy and Safety of AK002 in Patients That Were Previously Enrolled in AK002-016 or AK002-012 Studies and Have Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
July 7, 2023 (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 3, open-label, extension study to assess the long term efficacy and safety of lirentelimab given monthly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Gastritis, Eosinophilic Duodenitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3.0 mg/kg of Lirentelimab (AK002)
Arm Type
Experimental
Arm Description
Subjects in this arm will receive up to 18 monthly doses (3mg/kg) of lirentelimab (AK002)
Intervention Type
Drug
Intervention Name(s)
lirentelimab
Other Intervention Name(s)
AK002
Intervention Description
Lirentelimab (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 lirentelimab by evaluating adverse events assessed using the CTCAE version 5.0
Time Frame
Day 561 (End of Study)
Title
The safety and tolerability of lirentelimab 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 561 (End of Study)
Title
Evaluation of symptoms of EG and/or EGE using a daily disease-specific patient questionnaire (PRO Questionnaire)
Time Frame
Basline to Day 561 (End of Study)
Title
Changes in the number of eosinophils in gastric and/or duodenal mucosa
Time Frame
Baseline to Day 505

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Provide written informed consent. Completed Study AK002-016, defined as having received 6 infusions of study drug and followed through Day 176 (±3) or completed Study AK002-012, defined as having received the cohort-appropriate amount of doses and followed for 5 months after last dose of study drug. If patient is on pre-existing dietary restrictions, willingness to maintain those restrictions, 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. Key Exclusion Criteria: 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 Period, 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 Patterson, MD
Organizational Affiliation
Allakos Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Allakos Investigational Site 216-068
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Allakos Investigational Site 216-002
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Allakos Investigational Site 216-035
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Allakos Investigational Site 216-032
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Allakos Investigational Site 216-014
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Allakos Investigational Site 216-038
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Allakos Investigational Site 216-049
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Allakos Investigational Site 216-034
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Allakos Investigational Site 216-063
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Allakos Investigational Site 216-027
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Allakos Investigational Site 216-056
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Allakos Investigational Site 216-013
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Allakos Investigational Site 216-053
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Allakos Investigational Site 216-007
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Allakos Investigational Site 216-001
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
Facility Name
Allakos Investigational Site 216-026
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Allakos Investigational Site 216-052
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Allakos Investigational Site 216-051
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Allakos Investigational Site 216-005
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Allakos Investigational Site 216-042
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Allakos Investigational Site 216-045
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Allakos Investigational Site 216-025
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Allakos Investigational Site 216-020
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Allakos Investigational Site 216-048
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Allakos Investigational Site 216-050
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Allakos Investigational Site 216-031
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Allakos Investigational Site 216-028
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Allakos Investigational Site 216-044
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Allakos Investigational Site 216-021
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allakos Investigational Site 216-006
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37343
Country
United States
Facility Name
Allakos Investigational Site 216-003
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Allakos Investigational Site 216-011
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Allakos Investigational Site 216-062
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37663
Country
United States
Facility Name
Allakos Investigational Site 216-022
City
Austin
State/Province
Texas
ZIP/Postal Code
78742
Country
United States
Facility Name
Allakos Investigational Site 216-039
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Allakos Investigational Site 216-030
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Allakos Investigational Site 216-055
City
Sandy
State/Province
Utah
ZIP/Postal Code
84092
Country
United States
Facility Name
Allakos Investigational Site 216-064
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

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