Clinical trial NCT04620811: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Eosinophilic Gastritis
Eosinophilic Duodenitis
Lead sponsor: Allakos Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-09
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0
timeFrame: Through study completion, up to 21 months
Secondary outcomes:
Other outcomes:
measure: Proportion of Tissue Eosinophil Responders
timeFrame: At Follow-up EGD (Esophago-Gastro-Duodenoscopy) (Day 505 or 28 days after last dose if ET)
measure: Change in PRO Total System Score (TSS) From AK002-016/AK002-012 Baseline
timeFrame: Main Study Baseline to Extension Weeks 71-72
Locations:
city: Birmingham
country: United States
facility: Allakos Investigational Site 216-068
state: Alabama
city: Huntsville
country: United States
facility: Allakos Investigational Site 216-002
state: Alabama
city: Phoenix
country: United States
facility: Allakos Investigational Site 216-035
state: Arizona
city: Chula Vista
country: United States
facility: Allakos Investigational Site 216-032
state: California
city: Santa Monica
country: United States
facility: Allakos Investigational Site 216-014
state: California
city: Tustin
country: United States
facility: Allakos Investigational Site 216-038
state: California
city: Walnut Creek
country: United States
facility: Allakos Investigational Site 216-049
state: California
city: Aurora
country: United States
facility: Allakos Investigational Site 216-034
state: Colorado
city: Brandon
country: United States
facility: Allakos Investigational Site 216-063
state: Florida
city: Edgewater
country: United States
facility: Allakos Investigational Site 216-027
state: Florida
city: Jacksonville
country: United States
facility: Allakos Investigational Site 216-056
state: Florida
city: Miami
country: United States
facility: Allakos Investigational Site 216-013
state: Florida
city: New Port Richey
country: United States
facility: Allakos Investigational Site 216-053
state: Florida
city: Chicago
country: United States
facility: Allakos Investigational Site 216-007
state: Illinois
city: Crowley
country: United States
facility: Allakos Investigational Site 216-001
state: Louisiana
city: Boston
country: United States
facility: Allakos Investigational Site 216-026
state: Massachusetts
city: Boston
country: United States
facility: Allakos Investigational Site 216-052
state: Massachusetts
city: Boston
country: United States
facility: Allakos Investigational Site 216-051
state: Massachusetts
city: Rochester
country: United States
facility: Allakos Investigational Site 216-005
state: Minnesota
city: Kansas City
country: United States
facility: Allakos Investigational Site 216-042
state: Missouri
city: Reno
country: United States
facility: Allakos Investigational Site 216-045
state: Nevada
city: New York
country: United States
facility: Allakos Investigational Site 216-025
state: New York
city: Chapel Hill
country: United States
facility: Allakos Investigational Site 216-020
state: North Carolina
city: Durham
country: United States
facility: Allakos Investigational Site 216-048
state: North Carolina
city: Winston-Salem
country: United States
facility: Allakos Investigational Site 216-050
state: North Carolina
city: Cincinnati
country: United States
facility: Allakos Investigational Site 216-031
state: Ohio
city: Cincinnati
country: United States
facility: Allakos Investigational Site 216-028
state: Ohio
city: Mentor
country: United States
facility: Allakos Investigational Site 216-044
state: Ohio
city: Philadelphia
country: United States
facility: Allakos Investigational Site 216-021
state: Pennsylvania
city: Chattanooga
country: United States
facility: Allakos Investigational Site 216-006
state: Tennessee
city: Chattanooga
country: United States
facility: Allakos Investigational Site 216-003
state: Tennessee
city: Chattanooga
country: United States
facility: Allakos Investigational Site 216-011
state: Tennessee
city: Kingsport
country: United States
facility: Allakos Investigational Site 216-062
state: Tennessee
city: Austin
country: United States
facility: Allakos Investigational Site 216-022
state: Texas
city: Ogden
country: United States
facility: Allakos Investigational Site 216-039
state: Utah
city: Salt Lake City
country: United States
facility: Allakos Investigational Site 216-030
state: Utah
city: Sandy
country: United States
facility: Allakos Investigational Site 216-055
state: Utah
city: Spokane
country: United States
facility: Allakos Investigational Site 216-064
state: Washington
Study officials:
affiliation: Allakos Inc.
name: Craig Patterson, MD
role: STUDY_DIRECTOR
References: