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

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ClinicalTrials.gov Identifier: NCT03664960
Recruitment Status : Active, not recruiting
First Posted : September 11, 2018
Last Update Posted : June 23, 2021
Information provided by (Responsible Party):
Allakos Inc.

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.

Condition or disease Intervention/treatment Phase
Eosinophilic Gastritis Eosinophilic Gastroenteritis Eosinophilic Duodenitis Drug: AK002 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: 1 to 3.0 mg/kg of AK002
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
AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.

Primary Outcome Measures :
  1. The safety and tolerability of AK002 by evaluating adverse events assessed using the CTCAE version 4.03 [ Time Frame: Day 785 (End of Study) ]
  2. The safety and tolerability of AK002 as assessed by symptom-directed physical examination of reported or observed patient symptoms warranting examination, including assessments of possible infusion site reactions and infusion-related reactions [ Time Frame: Day 1 to Day 785 (End of Study) ]
  3. Evaluation of symptoms of EG and/or EoD (formerly referred to as EGE) using a daily disease-specific patient questionnaire (PRO Questionnaire) [ Time Frame: Baseline to Day 785 (End of Study) ]
  4. Changes in the number of eosinophils in gastric and/or duodenal mucosa [ Time Frame: Baseline to Day 729 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 and willing to begin extended dosing on or about Day 113.
  3. Able and willing to comply with all study procedures.
  4. 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.
  5. 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. Planned or expected vaccination with live attenuated vaccines during the treatment, or vaccination expected within 5 half-lives (4 months) of AK002 administration.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664960

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Sponsors and Collaborators
Allakos Inc.
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Study Director: Craig Paterson, MD Allakos Inc.
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Responsible Party: Allakos Inc.
ClinicalTrials.gov Identifier: NCT03664960    
Other Study ID Numbers: AK002-003X
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allakos Inc.:
Eosinophilic Gastritis
Eosinophilic Gastroenteritis
Eosinophilic gastrointestinal disorders
Eosinophilic Duodenitis
Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esophageal Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Immune System Diseases
Intestinal Diseases
Duodenal Diseases