Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease



Status:Terminated
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/30/2019
Start Date:April 30, 2015
End Date:December 22, 2016

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A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's Disease

This study will primarily evaluate the safety and efficacy of andecaliximab in adults with
active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by
an Open-Label Extension. Participants who complete the Double-Blind Phase will be eligible to
enroll in the optional Open-Label Extension for an additional 44 weeks. Participants who
complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to
continue treatment with andecaliximab for an additional 156 weeks.


Key Inclusion Criteria:

- Ability to provide a written informed consent

- Females of childbearing potential must have a negative pregnancy test at screening and
baseline

- Documented diagnosis of Crohn's disease with a minimum disease duration of 6 months
with involvement of the ileum and/or colon at a minimum

- Moderately to severely active Crohn's disease as defined by a Crohn's Disease Activity
Index (CDAI) total score between 220-450 (inclusive) AND with evidence of active
disease as measured by ileocolonoscopy

- Within the previous 5 years, demonstrated an inadequate clinical response or
intolerance of at least one of the following agents:

- Corticosteroids

- Immunomodulators

- Tumor necrosis factor-alpha (TNFα) antagonists

- Vedolizumab

- May be receiving the following drugs:

- Oral 5-aminosalicylate (5-ASA)

- Oral corticosteroid therapy

- Antidiarrheals for chronic diarrhea

- Azathioprine or 6-mercaptopurine (6-MP) or methotrexate

- Antibiotics for the treatment of Crohn's disease

- Able to comply with the dosing instructions for study drug and able to comply with the
study visits and requirements

Key Exclusion Criteria:

- Evidence of abscess at screening

- Extensive colonic resection (subtotal or total colectomy) or history of > 2 small
bowel resections

- Ileostomy, colostomy, or symptomatic stenosis of the intestine

- Current use of oral corticosteroids at a dose equivalent to > 30 mg/day of prednisone

- Ulcerative colitis or indeterminate colitis

- Short bowel syndrome

- Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli,
Salmonella, Shigella, Campylobacter or Yersinia

- Treatment with any monoclonal antibody within 4 weeks of screening

- History or evidence of colonic mucosal dysplasia

- HIV, hepatitis B, hepatitis C, or tuberculosis (TB) infection

- Participated in a clinical study with an investigational drug or biologic within the
last 30 days

- Any chronic medical condition (including, but not limited to, cardiac or pulmonary
disease) that, in the opinion of the investigator, would make the individual
unsuitable for the study or would prevent compliance with the study protocol

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
We found this trial at
34
sites
Arlington, Texas 76012
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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610 3rd St # 206
Macon, Georgia 31201
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Macon, GA
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Asheville, North Carolina 28801
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Chesterfield, Michigan 48098
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Cincinnati, OH
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Clive, Iowa 50325
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Concord, New South Wales
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Dothan, AL
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Egg Harbor Township, New Jersey 08234
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Germantown, Tennessee 38138
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Houston, TX
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Indianapolis, IN
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lone Tree, Colorado
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Mentor, Ohio 44060
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Monroe, Louisiana 71201
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Naples, Florida 34102
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Norfolk, Virginia 23502
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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Richmond, Virginia 23249
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, New York
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Antonio, Texas 78229
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Scottsdale, Arizona 85259
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Shreveport, Louisiana 71103
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Topeka, KS
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