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



Status:Enrolling by invitation
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:2/20/2019
Start Date:November 14, 2018
End Date:April 2020

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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

This is a Phase 2, open-label, extension study to assess the safety and tolerability of
AK002, given monthly for 8 doses.


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.
We found this trial at
16
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
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
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Austin, Texas 78704
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NIH
Bethesda, Maryland 20892
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Chattanooga, Tennessee 37421
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Cincinnati, Ohio 45229
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
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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New York, New York
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Rochester, Minnesota 55905
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Ventura, California 93003
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