Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis



Status:Completed
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:2/17/2019
Start Date:July 2015
End Date:February 14, 2018

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to determine whether etrasimod is a safe and effective treatment
for ulcerative colitis.


Inclusion Criteria:

- Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic
score

- Evidence of colonic ulcerative colitis activity on endoscopy

Exclusion Criteria:

- Within 30 days prior to randomization, receipt of any of the following for the
treatment of underlying disease: Non-biologic therapies (eg, cyclosporine, tacrolimus,
tofacitinib, thalidomide), a non-biologic investigational therapy or an approved
non-biologic therapy in an investigational protocol

- Within 60 days prior to randomization, receipt of any of the following: Infliximab,
adalimumab, golimumab, certolizumab or any other investigational or approved biologic
agent

- Any prior exposure to natalizumab, efalizumab, or rituximab
We found this trial at
31
sites
1604 Arena Drive
Kingswood, 32409
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Birmingham, Alabama 35294
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Birmingham, AL
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Chicago, Illinois 60611
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Chicago, IL
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Cincinnati, Ohio 45267
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Cincinnati, OH
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DeSoto, Texas 75115
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DeSoto, TX
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Dothan, Alabama 36305
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Dothan, AL
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Germantown, Tennessee 38138
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Germantown, TN
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Great Neck, New York 11021
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Great Neck, NY
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Hermitage, Tennessee 37076
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Hermitage, TN
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2350 Hassell Road
Hoffman Estates, Illinois 60169
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Hoffman Estates, IL
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Hollywood, Florida 33021
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Hollywood, FL
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Houston, Texas 77030
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Houston, TX
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Miami, Florida 33134
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Miami, FL
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Naples, Florida 34102
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Naples, FL
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Ogden, Utah 84405
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Ogden, UT
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Orlando, Florida 32825
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Orlando, FL
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1117 Stadium Street
Pittsburgh, Pennsylvania 15219
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Pittsburgh, PA
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Port Orange, Florida 32127
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Port Orange, FL
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Raleigh, North Carolina 27612
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Raleigh, NC
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Richmond, Virginia 23298
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Richmond, VA
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Roanoke, Virginia 24014
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Roanoke, VA
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Rochester, New York 14642
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Rochester, NY
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1200 5th Avenue
Seattle, Washington 98101
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Seattle, WA
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1200 5th Avenue
Seattle, Washington 98195
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Seattle, WA
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Sweetwater, Florida 33172
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Sweetwater, FL
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Temple, Texas 76508
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Temple, TX
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649 East Easy Street
Thousand Oaks, California 91360
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Thousand Oaks, CA
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Traverse City, Michigan 49686
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Traverse City, MI
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Troy, Michigan 48098
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Troy, MI
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Urbana, Illinois 61801
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Urbana, IL
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Wauwatosa, Wisconsin 53226
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Wauwatosa, WI
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