FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

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

Study Purpose

This is a Phase 2, double-blind, randomized, placebo-controlled study to assess the effects of AK002, given monthly for 4 doses. It is hypothesized that AK002 is more effective than placebo control (alternative hypothesis) in reducing the number of eosinophils per high power field (HPF) in gastric and/or duodenal biopsies before and after receiving AK002 or placebo versus no difference between AK002 and placebo control (null hypothesis).

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female aged ≥18 and ≤80 years at the time of signing ICF. 2. Average weekly score of ≥3 (on a scale from 0-10, recorded for either abdominal pain, diarrhea and/or nausea on the PRO questionnaire during at least 2 out of 3 weeks of PRO collection. A minimum of four questionnaires must be completed each qualifying week. 3. Eosinophilia of the gastric mucosa ≥30 eosinophils/HPF in 5 HPFs and/or eosinophilia of the duodenal mucosa ≥30 eosinophils/HPF in 3 HPFs from the EGD performed during the screening period, without any other cause for the gastric eosinophilia (e.g., parasitic or other infection or malignancy). 4. Subjects must have failed or not be adequately controlled on standard-of-care treatments for EG or EGE symptoms (which could include PPIs, systemic or topical corticosteroids, and/or diet, among others). 5. If on other treatments for EG, EGE, or EoE at enrollment, stable dose for at least 5 half-lives prior to screening and willingness to continue on that dose for the duration of the study. 6. If subject is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study, as much as possible. 7. Able and willing to comply with all study procedures. 8. Female subjects must be either post-menopausal for at least 1 year with FSH level >40 mIU/mL at screening 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 from screening until the end of the study, or for 120 days following the last dose of study drug, whichever is longer. Male subjects with female partners of childbearing potential must agree to use a highly effective method of contraception from screening 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. Known hypersensitivity to any constituent of the study drug. 2. Diagnosis of celiac disease or H. pylori infection as determined by screening EGD or a history of celiac disease diagnosed by prior EGD. 3. Presence of abnormal laboratory values considered by the Investigator to be clinically significant. 4. Grade 2 or higher lymphopenia (<0.8 × 109/L lymphocytes). 5. Any disease or condition (medical or surgical) or cardiac abnormality, which, in the opinion of the Investigator, would place the subject at increased risk. 6. History of malignancy; except carcinoma in situ in the cervix, early stage prostate cancer, or non-melanoma skin cancers. However, cancers that have been in remission for more than 5 years and are considered cured, can be enrolled (with the exception of breast cancer). All history of malignancy (including diagnosis, dates, and compliance with cancer screening recommendations) must be documented and certified by the Investigator, along with the statement that in their clinical judgment the tissue eosinophilia is attributable to EGID, rather than recurrence of malignancy. 7. Treatment with chemotherapy or radiotherapy in the preceding 6 months. 8. Treatment for a clinically significant helminthic parasitic infection within 6 months of screening and/or a positive helminthic test at screening. 9. Use of any medications that may interfere with the study such as immunosuppressive or immunomodulatory drugs (including azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, tacrolimus, anti-TNF, anti-IL-5, anti-IL-5 receptor, dupilumab, anti-IgE antibodies, omalizumab) or systemic corticosteroids with a daily dose >10 mg of prednisone or equivalent, during 5 half-lives prior to screening or during the screening period, except for omalizumab taken in asthma and/or urticaria patients where their asthma and/or urticaria cannot be controlled on other medications. In such cases, the dose of omalizumab should remain stable during screening and throughout the study. 10. 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 of the study drug administration. 11. Known history of alcohol, drug, or other substance abuse or dependence. 12. Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to administration of study drug (or 90 days or 5 half-lives, whichever is longer, for biologic products). 13. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study. 14. Any other reason that in the opinion of the Investigator or Medical Monitor makes the patient unsuitable for enrollment.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03496571

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Allakos, Inc.

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Henrik Rasmussen, MD, PhD
Principal Investigator Affiliation Allakos, Inc.

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Eosinophilic Gastritis, Eosinophilic Gastroenteritis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Avant Research Associates, Guntersville, Alabama

Status

Withdrawn

Address

Avant Research Associates

Guntersville, Alabama, 35976

Site Contact

443-699-5230

Phoenix, Arizona

Status

Recruiting

Address

Phoenician Centers for Research and Innovation

Phoenix, Arizona, 85021

Site Contact

Cari Cone

480-346-9514

Ventura Clinical Trials, Ventura, California

Status

Recruiting

Address

Ventura Clinical Trials

Ventura, California, 93003

Site Contact

Iliana Rojas

805-339-0549

Riverside Clinical Research, Edgewater, Florida

Status

Recruiting

Address

Riverside Clinical Research

Edgewater, Florida, 32132

Site Contact

Tamie Ashby

386-428-7730 #332

Advanced Research Institute, New Port Richey, Florida

Status

Recruiting

Address

Advanced Research Institute

New Port Richey, Florida, 34653

Site Contact

Lynnette Mitchell

727-835-3261

Consultive Gastroenterology, Atlanta, Georgia

Status

Recruiting

Address

Consultive Gastroenterology

Atlanta, Georgia, 30308

Site Contact

Robin Clark

443-699-5230

Northwestern, Chicago, Illinois

Status

Recruiting

Address

Northwestern

Chicago, Illinois, 60611

Site Contact

Angelika Zalewski

312-695-4054

Indiana University Health, Indianapolis, Indiana

Status

Recruiting

Address

Indiana University Health

Indianapolis, Indiana, 46202

Site Contact

Miranda Williams

317-274-5630

University of Iowa, Iowa City, Iowa

Status

Recruiting

Address

University of Iowa

Iowa City, Iowa, 52242

Site Contact

Ethan Hoover

319-335-9767

National Institutes of Health, Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health

Bethesda, Maryland, 20892

Site Contact

Nicole Holland-Thomas

301-402-5969

Tufts Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Tufts Medical Center

Boston, Massachusetts, 02111

Site Contact

Teresa Brown

617-636-4941

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

Chadrick Hinson

507-284-2631

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Site Contact

Talaya McCright-Gill

212-241-7099

Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599

Site Contact

Ashley Arrington

919-966-2996

Cincinnati Children's Hospital, Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229

Site Contact

Hilary Wilson-Perez

513-803-5074

Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania, Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104

Site Contact

Maureen DeMarshall

443-699-5230

Care Access Research, Pottsville, Pennsylvania

Status

Recruiting

Address

Care Access Research

Pottsville, Pennsylvania, 17901

Site Contact

Sherri Dutter

570-478-5120

ClinSearch, Chattanooga, Tennessee

Status

Recruiting

Address

ClinSearch

Chattanooga, Tennessee, 37421

Site Contact

Christy Schmeck

423-698-4584

Vanderbilt University, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University

Nashville, Tennessee, 37212

Site Contact

Nicolas Ryan

615-875-7502

Avant Research Associates, Austin, Texas

Status

Recruiting

Address

Avant Research Associates

Austin, Texas, 78704

Site Contact

Candice Peel

512-814-6038

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84132

Site Contact

Annie Kirk

801-587-9050

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.