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

Eosinophilic Gastroenteritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03664960
• Other study ID #: AK002-003X
• Status: Completed
• Phase: Phase 2
• Start date: November 14, 2018
• Est. completion date: November 2, 2021

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 2, 2021
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Avant Research Associates	Austin	Texas
United States	NIH	Bethesda	Maryland
United States	Tufts Medical Center	Boston	Massachusetts
United States	University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	ClinSearch	Chattanooga	Tennessee
United States	Northwestern	Chicago	Illinois
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	University of Iowa	Iowa City	Iowa
United States	Vanderbilt University	Nashville	Tennessee
United States	Advanced Research Institute	New Port Richey	Florida
United States	Mount Sinai	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Phoenician Centers for Research and Innovation	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Utah	Salt Lake City	Utah
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Ventura Clinical Trials	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Allakos Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03	Adverse events assessed using the CTCAE version 4.03	Through study completion, up to 28 months
Secondary	Percent Change in PRO Total Symptom Score (TSS) From AK002-003 Baseline	The PRO Total Symptom Score (TSS) is a patient-reported outcome (PRO) questionnaire comprises the following 8 symptoms: abdominal pain, nausea, vomiting, early satiety, loss of appetite, abdominal cramping, bloating, and diarrhea. Individual symptom scores ranged from 0 to 10. The daily total symptom score ranged from 0 to 80, with higher scores indicating greater severity. The End of treatment TSS score is defined as the average of the 14 daily scores on or after the day of the last dose of the extension study.	AK002-003 Baseline to End of Treatment (2 weeks post last dose, up to 26 months)
Secondary	Changes in the Number of Eosinophils in Gastric and/or Duodenal Mucosa From AK002-003 Baseline	Percentage of Change in the Number of Eosinophils in Gastric and/or Duodenal Mucosa in each group from AK002-003 Baseline	AK002-003 Baseline to Day 547