Clinical trial NCT03664960: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Eosinophilic Gastritis
Eosinophilic Gastroenteritis
Eosinophilic Duodenitis
Keywords: Eosinophilic Gastritis
Eosinophilic Gastroenteritis
Eosinophil
EG
EGE
EGID
Eosinophilic gastrointestinal disorders
Eosinophilic Duodenitis
EoD
Lead sponsor: Allakos Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-11
Enrollment: 58
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 2, open-label, extension study to assess the safety and tolerability of AK002, given monthly for up to 26 doses.


Eligibility 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 or discontinued from treatment due to high eosinophil counts prior to infusions 2, 3, or 4 and willing to begin extended dosing on or about Day 113 (for AK002-003 completers) or within 6 months of last dosing for patients discontinued from treatment.
3. If patient is on pre-existing dietary restrictions, willingness to note any changes that occur from the Baseline diet, 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.

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. Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives (4 months) of study drug administration. All types and formulations of vaccines (including live attenuated vaccines) authorized by FDA or other regulatory authority for the prevention of COVID-19 may be administered before, during, or after this study. The vaccine should not be administered within 7 days prior to and within 7 days after the administration of AK002 so that any side effects caused by either of the 2 medications can be more easily determined.
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.
7. Diagnosis of Hypereosinophilic Syndrome (HES), based on standard criteria (blood eosinophils \>1500/µL with involvement of either the heart, nervous system, and/or bone marrow).

Primary outcomes:
measure: The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03
timeFrame: Through study completion, up to 28 months
Secondary outcomes:
measure: Percent Change in PRO Total Symptom Score (TSS) From AK002-003 Baseline
timeFrame: AK002-003 Baseline to End of Treatment (2 weeks post last dose, up to 26 months)
measure: Changes in the Number of Eosinophils in Gastric and/or Duodenal Mucosa From AK002-003 Baseline
timeFrame: AK002-003 Baseline to Day 547
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenician Centers for Research and Innovation
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Ventura
country: United States
facility: Ventura Clinical Trials
state: California
city: New Port Richey
country: United States
facility: Advanced Research Institute
state: Florida
city: Chicago
country: United States
facility: Northwestern
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Bethesda
country: United States
facility: NIH
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina - Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Austin
country: United States
facility: Avant Research Associates
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Allakos Inc.
name: Craig Paterson, MD
role: STUDY_DIRECTOR
References: