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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03664960
Recruitment Status : Active, not recruiting
First Posted : September 11, 2018
Last Update Posted : March 26, 2020
Sponsor:
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 20 doses.

Condition or disease Intervention/treatment Phase
Eosinophilic Gastritis Eosinophilic Gastroenteritis 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 Gastroenteritis
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 to 3.0 mg/kg of AK002
Subjects in this arm will receive 20 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 617 (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 617 (End of Study) ]
  3. Evaluation of symptoms of EG and/or EGE using a daily disease-specific patient questionnaire (PRO Questionnaire) [ Time Frame: Baseline to Day 617 (End of Study) ]
  4. Changes in the number of eosinophils in gastric and/or duodenal mucosa [ Time Frame: Baseline to Day 547 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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 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


Locations
Show Show 17 study locations
Sponsors and Collaborators
Allakos, Inc.
Investigators
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Study Director: Henrik Rasmussen, MD, PhD 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: March 26, 2020
Last Verified: March 2020
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
Eosinophil
EG
EGE
EGID
Eosinophilic gastrointestinal disorders
Additional relevant MeSH terms:
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Gastroenteritis
Gastritis
Eosinophilic Esophagitis
Enteritis
Eosinophilia
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esophagitis
Esophageal Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Intestinal Diseases