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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

The primary objectives of this study are as follows: 1) To evaluate the efficacy of andecaliximab to induce endoscopy, rectal bleeding, and stool frequency (EBS) clinical remission at Week 8 (Cohort 1); 2) To evaluate the efficacy of andecaliximab to maintain EBS clinical remission at Week 52 (Cohort 2); and 3) To evaluate the safety and tolerability of andecaliximab. The study will consist of 3 parts: Induction Phase (Cohort 1), Maintenance Phase (Cohort 2), and an optional Extended Treatment Phase.

Key facts

Study ID

NCT02520284

Run by

Gilead Sciences

People needed

165

Starts

2015-09-01

Expected to finish

2016-11-01

Last updated by the study team

2019-04-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Study site — Wheat Ridge, Colorado, United States
• Study site — Lauderdale Lakes, Florida, United States
• Study site — Miramar, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Zephyrhills, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Topeka, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Monroe, Louisiana, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Plymouth, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Egg Harbor, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Mentor, Ohio, United States
• Study site — Rochester, Ohio, United States
• Study site — Germantown, Tennessee, United States
• Study site — Hermitage, Tennessee, United States
• Study site — Arlington, Texas, United States
• Study site — Baytown, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Irving, Texas, United States
• Study site — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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