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

NCT03664960 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AK002-003X
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 17

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.

Conditions

Eosinophilic Gastritis; Eosinophilic Gastroenteritis; Eosinophilic Duodenitis

Keywords

Eosinophilic Gastritis; Eosinophilic Gastroenteritis; Eosinophil; EG; EGE; EGID; Eosinophilic gastrointestinal disorders; Eosinophilic Duodenitis; EoD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percent Change in PRO Total Symptom Score (TSS) From AK002-003 Baseline

  AK002-003 Baseline to End of Treatment (2 weeks post last dose, up to 26 months)

• Changes in the Number of Eosinophils in Gastric and/or Duodenal Mucosa From AK002-003 Baseline

  AK002-003 Baseline to Day 547

Study Arms (1)

1 to 3.0 mg/kg of AK002

EXPERIMENTAL

Subjects in this arm will receive 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg

Drug: AK002

Interventions

AK002 DRUG

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

1 to 3.0 mg/kg of AK002

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent.
• 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.
• If patient is on pre-existing dietary restrictions, willingness to note any changes that occur from the Baseline diet, 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.

You may not qualify if:

• Poor tolerance to previous administration of AK002 in the opinion of the Investigator.
• 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.
• 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.
• 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.
• 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).

Sponsors & Collaborators

• Allakos Inc.: lead

Study Sites (17)

Phoenician Centers for Research and Innovation

Phoenix, Arizona, 85021, United States

Location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Ventura Clinical Trials

Ventura, California, 93003, United States

Location

Advanced Research Institute

New Port Richey, Florida, 34653, United States

Location

Northwestern

Chicago, Illinois, 60611, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

NIH

Bethesda, Maryland, 20892, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

ClinSearch

Chattanooga, Tennessee, 37421, United States

Location

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

Avant Research Associates

Austin, Texas, 78704, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Eosinophilic enteropathy; Eosinophilic Esophagitis

Interventions

AK002

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Medical Information
• Organization: Allakos

medinfo@allakos.com

650-597-5002

Study Officials

• Craig Paterson, MD

  Allakos Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 11, 2018
• Study Start: November 14, 2018
• Primary Completion: November 2, 2021
• Study Completion: November 2, 2021
• Last Updated: February 28, 2024
• Results First Posted: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)