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 |
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.
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
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