Overview

This trial is active, not recruiting.

Condition ulcerative colitis
Treatments gs-5745, placebo
Phase phase 2/phase 3
Target MMP-9
Sponsor Gilead Sciences
Start date September 2015
End date February 2019
Trial size 1600 participants
Trial identifier NCT02520284, 2014-005217-24, GS-US-326-1100

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Participants will receive GS-5745 weekly doses for 8 weeks. Based on Week 8 assessment results, participants will either continue on blinded treatment or will be offered open-label GS-5745 weekly.
gs-5745
GS-5745 150 mg administered subcutaneously
(Experimental)
Participants will receive weekly GS-5745 doses alternating with placebo for 8 weeks. Based on Week 8 assessment results, participants will either continue on blinded treatment or will be offered open-label GS-5745 weekly.
gs-5745
GS-5745 150 mg administered subcutaneously
placebo
GS-5745 placebo administered subcutaneously
(Placebo Comparator)
Participants will receive GS-5745 placebo weekly for 8 weeks. Based on Week 8 assessment results, participants will either continue on blinded treatment or will be offered open-label GS-5745 weekly.
gs-5745
GS-5745 150 mg administered subcutaneously
placebo
GS-5745 placebo administered subcutaneously
(Experimental)
Participants will receive open-label GS-5745 at the optimal regimen (based on Cohort 1 data analysis) for the first 8 weeks, followed by blinded GS-5745 weekly or every 2 weeks (whichever is determined to be the optimal regimen) for a total of 43 doses.
gs-5745
GS-5745 150 mg administered subcutaneously
(Experimental)
Participants will receive open-label GS-5745 at the optimal regimen (based on Cohort 1 data analysis) for the first 8 weeks, followed by weekly GS-5745 doses alternating with placebo for a total dose of 21 active GS-5745 doses. Note this treatment group will only be initiated if the optimal dosing regimen is determined to be weekly.
gs-5745
GS-5745 150 mg administered subcutaneously
placebo
GS-5745 placebo administered subcutaneously
(Placebo Comparator)
Participants will receive open-label GS-5745 at the optimal regimen (based on Cohort 1 data analysis) for the first 8 weeks, followed by GS-5745 placebo weekly or every 2 weeks (whichever is determined to be the optimal regimen).
gs-5745
GS-5745 150 mg administered subcutaneously
placebo
GS-5745 placebo administered subcutaneously
(Experimental)
All participants that complete 52 weeks of treatment (in either Cohorts 1 or 2) will have the option to enter the Extended Treatment Phase to receive open-label GS-5745 weekly.
gs-5745
GS-5745 150 mg administered subcutaneously

Primary Outcomes

Measure
For Cohort 1, proportion of participants achieving remission at Week 8 based on select mayo clinical score (MCS) measures
time frame: Week 8
For Cohort 2, proportion of participants achieving remission at Week 52 based on select MCS measures
time frame: Week 52

Secondary Outcomes

Measure
For Cohort 1, proportion of participants achieving MCS remission at Week 8
time frame: Week 8
For Cohort 1, proportion of participants achieving MCS response at Week 8
time frame: Week 8
For Cohort 1, proportion of participants achieving sustained clinical remission at Week 52 based on select MCS measures
time frame: Weeks 8 and 52
For Cohort 1, proportion of participants achieving endoscopic remission at Week 8
time frame: Week 8
For Cohort 1, proportion of participants achieving endoscopic response at Week 8
time frame: Week 8
For Cohort 1, proportion of participants achieving mucosal healing as determined by histologic measures at Week 8
time frame: Week 8
For Cohort 1, proportion of participants achieving remission as defined by MCS remission (alternative definition) at Week 8
time frame: Week 8
For Cohort 2, proportion of participants achieving MCS remission at Week 52
time frame: Week 52
For Cohort 2, proportion of participants achieving corticosteroid-free clinical remission at Week 52 based on select MCS measures
time frame: Week 52
For Cohort 2, proportion of participants achieving endoscopic remission at Week 52
time frame: Week 52
For Cohort 2, proportion of participants achieving mucosal healing as determined by histologic measures at Week 52
time frame: Week 52
For Cohort 2, proportion of participants achieving remission as defined by MCS remission (alternative definition) at Week 52
time frame: Week 52
For Cohort 2, proportion of participants achieving corticosteroid-free clinical remission for at least 24 weeks prior to Week 52
time frame: Up to 52 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.