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



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:1/9/2019
Start Date:July 18, 2018
End Date:September 2019
Contact:Henrik Rasmussen, MD, PhD
Email:hrasmussen@allakos.com
Phone:443-699-5230

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A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis

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).


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.
We found this trial at
23
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Kathryn Peterson
Phone: 801-587-9050
University of Utah Research is a major component in the life of the U benefiting...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: John Leung
Phone: 617-636-4941
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Evan Dellon
Phone: 919-966-2996
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Yehudith Assouline-Dayan
Phone: 319-335-9767
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Atlanta, Georgia 30308
Principal Investigator: Gary Richter
Phone: 404-839-5351
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Aurora, Colorado 80045
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Austin, Texas 78704
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Phone: 512-814-6038
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Bethesda, Maryland 20892
Principal Investigator: Paneez Khoury
Phone: 301-402-5969
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Chattanooga, Tennessee 37421
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Chicago, Illinois 49201
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Cincinnati, Ohio 45229
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Edgewater, Florida 32132
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Guntersville, Alabama 35976
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Phone: 256-763-0628
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Indianapolis, Indiana 46202
Principal Investigator: Robert Siwiec
Phone: 317-274-5630
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Michael Vaezi
Phone: 615-875-7502
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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New Port Richey, Florida
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Phone: 727-835-3261
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Mirna Chehade
Phone: 212-241-7099
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 85021
Principal Investigator: Kenneth Boren
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Pottsville, Pennsylvania 17901
Principal Investigator: Glenn Freed
Phone: 570-478-5120
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Rochester, Minnesota 55905
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Scottsdale, Arizona 85259
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Ventura, California 93003
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