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

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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
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