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

Eosinophilic Gastritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04620811
• Other study ID #: AK002-016X
• Status: Completed
• Phase: Phase 3
• Start date: December 3, 2020
• Est. completion date: July 7, 2023

Study information

• Verified date: April 2024
• Source: Allakos Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 3, open-label, extension study to assess the long term efficacy and safety of lirentelimab given monthly.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: July 7, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Duodenitis
• Enteritis
• Eosinophilia
• Eosinophilic Duodenitis
• Eosinophilic Esophagitis
• Eosinophilic Gastritis
• Gastritis
• Gastroenteritis

Intervention

Drug:
• lirentelimab
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8

Locations

Country	Name	City	State
United States	Allakos Investigational Site 216-034	Aurora	Colorado
United States	Allakos Investigational Site 216-022	Austin	Texas
United States	Allakos Investigational Site 216-068	Birmingham	Alabama
United States	Allakos Investigational Site 216-026	Boston	Massachusetts
United States	Allakos Investigational Site 216-051	Boston	Massachusetts
United States	Allakos Investigational Site 216-052	Boston	Massachusetts
United States	Allakos Investigational Site 216-063	Brandon	Florida
United States	Allakos Investigational Site 216-020	Chapel Hill	North Carolina
United States	Allakos Investigational Site 216-003	Chattanooga	Tennessee
United States	Allakos Investigational Site 216-006	Chattanooga	Tennessee
United States	Allakos Investigational Site 216-011	Chattanooga	Tennessee
United States	Allakos Investigational Site 216-007	Chicago	Illinois
United States	Allakos Investigational Site 216-032	Chula Vista	California
United States	Allakos Investigational Site 216-028	Cincinnati	Ohio
United States	Allakos Investigational Site 216-031	Cincinnati	Ohio
United States	Allakos Investigational Site 216-001	Crowley	Louisiana
United States	Allakos Investigational Site 216-048	Durham	North Carolina
United States	Allakos Investigational Site 216-027	Edgewater	Florida
United States	Allakos Investigational Site 216-002	Huntsville	Alabama
United States	Allakos Investigational Site 216-056	Jacksonville	Florida
United States	Allakos Investigational Site 216-042	Kansas City	Missouri
United States	Allakos Investigational Site 216-062	Kingsport	Tennessee
United States	Allakos Investigational Site 216-044	Mentor	Ohio
United States	Allakos Investigational Site 216-013	Miami	Florida
United States	Allakos Investigational Site 216-053	New Port Richey	Florida
United States	Allakos Investigational Site 216-025	New York	New York
United States	Allakos Investigational Site 216-039	Ogden	Utah
United States	Allakos Investigational Site 216-021	Philadelphia	Pennsylvania
United States	Allakos Investigational Site 216-035	Phoenix	Arizona
United States	Allakos Investigational Site 216-045	Reno	Nevada
United States	Allakos Investigational Site 216-005	Rochester	Minnesota
United States	Allakos Investigational Site 216-030	Salt Lake City	Utah
United States	Allakos Investigational Site 216-055	Sandy	Utah
United States	Allakos Investigational Site 216-014	Santa Monica	California
United States	Allakos Investigational Site 216-064	Spokane	Washington
United States	Allakos Investigational Site 216-038	Tustin	California
United States	Allakos Investigational Site 216-049	Walnut Creek	California
United States	Allakos Investigational Site 216-050	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Allakos Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of Tissue Eosinophil Responders	A tissue eosinophil responder is defined as mean eosinophil count =4 cells/HPF in 5 gastric HPFs for EG only patients, =15 cells/HPF in 3 duodenal HPFs for EoD only patients, and =4 cells/HPF in 5 gastric HPFs and =15 cells/HPF in 3 duodenal HPFs for EG+EoD patients.	At Follow-up EGD (Esophago-Gastro-Duodenoscopy) (Day 505 or 28 days after last dose if ET)
Other	Change in PRO Total System Score (TSS) From AK002-016/AK002-012 Baseline	The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.	Main Study Baseline to Extension Weeks 71-72
Primary	The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0	Adverse events assessed using the CTCAE version 5.0.	Through study completion, up to 21 months