Safety and Efficacy of GS-5745 in Adults With Moderately to Severely Active Ulcerative Colitis



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:5/4/2016
Start Date:September 2015
End Date:February 2022
Contact:Gilead Study Team
Email:326-1100-centralcontact@gilead.com

Use our guide to learn which trials are right for you!

A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Ulcerative Colitis

This study will evaluate the efficacy, safety, and tolerability of GS-5745. It will consist
of 3 parts: Induction Study (Cohort 1), and Maintenance Study (Cohort 2), and an Extended
Treatment Phase.


Inclusion Criteria:

- Ulcerative Colitis (UC) confirmed on endoscopy

- Moderately to severely active UC (Mayo Score 6-12)

- May be receiving oral 5-aminosalicylate (ASA), oral corticosteroid, Azathioprine,
6-mercaptopurine(MP), or methotrexate

- Treatment failure with at least one of the following agents received;
Corticosteroids, Immunomodulators, tumor necrosis factor-alpha (TNFα) Antagonists,
Vedolizumab

Exclusion Criteria:

- Diagnose of Crohn's disease or indeterminate colitis

- Pregnant or lactating females

- Any chronic medical condition (including, but not limited to cardiac or pulmonary
disease, alcohol or drug abuse)

- Exhibit severe UC / clinically significant active infection

- History of malignancy in the last 5 years
We found this trial at
57
sites
?
mi
from
Plymouth, MN
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Baytown, TX
Click here to add this to my saved trials
?
mi
from
Brockton, MA
Click here to add this to my saved trials
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
?
mi
from
Chesapeake, VA
Click here to add this to my saved trials
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Columbia, MD
Click here to add this to my saved trials
15 Concord Road
Concord, New South Wales 2137
?
mi
from
Concord,
Click here to add this to my saved trials
?
mi
from
Corona, CA
Click here to add this to my saved trials
?
mi
from
Dothan, AL
Click here to add this to my saved trials
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
Egg Harbor, NJ
Click here to add this to my saved trials
?
mi
from
Flushing, NY
Click here to add this to my saved trials
?
mi
from
Germantown, TN
Click here to add this to my saved trials
?
mi
from
Hermitage, TN
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Inverness, FL
Click here to add this to my saved trials
?
mi
from
Irving, TX
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Lauderdale Lakes, Florida 33313
?
mi
from
Lauderdale Lakes, FL
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Lone Tree, CO
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Macon, GA
Click here to add this to my saved trials
?
mi
from
Mentor, OH
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miramar, FL
Click here to add this to my saved trials
?
mi
from
Monroe, LA
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
Rochester, MN
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
?
mi
from
Southlake, TX
Click here to add this to my saved trials
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
?
mi
from
Topeka, KS
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Wauwatosa, WI
Click here to add this to my saved trials
?
mi
from
Wheat Ridge, CO
Click here to add this to my saved trials
?
mi
from
Winter Park, FL
Click here to add this to my saved trials
?
mi
from
Worcester, MA
Click here to add this to my saved trials
?
mi
from
Zephyrhills, FL
Click here to add this to my saved trials