NCT02520284

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

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
BIOLOGICAL	Andecaliximab	Andecaliximab 150 mg administered via SC injection
BIOLOGICAL	Placebo	Placebo matched to andecaliximab administered via SC injection

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-09-01
• Completion: 2016-11-01
• First posted: 2015-08-11
• Last updated: 2019-04-10
• Results posted: 2019-04-10

Locations

87 sites across 23 countries: United States, Australia, Belgium, Bulgaria, Canada, Czechia, France, Hungary, Ireland, Italy, Latvia, Netherlands, New Zealand, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Switzerland, Taiwan, Ukraine, United Kingdom