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
Overview
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Gilead Sciences
- Enrollment
- 165
- Primary Endpoint
- For Cohort 1, Percentage of Participants With EBS Clinical Remission at Week 8
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Outcomes
Primary Outcomes
For Cohort 1, Percentage of Participants With EBS Clinical Remission at Week 8
Time Frame: Week 8
EBS clinical remission was defined as an endoscopic subscore of 0 or 1 (endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]); rectal bleeding subscore of 0 (rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes); and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1 (stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal).
Secondary Outcomes
- For Cohort 1, Percentage of Participants With MCS Remission at Week 8(Week 8)
- For Cohort 1, Percentage of Participants With Endoscopic Response at Week 8(Week 8)
- For Cohort 1, Percentage of Participants With Mucosal Healing as Determined by the Geboes Histologic Scoring System at Week 8(Week 8)
- For Cohort 1, Percentage of Participants With MCS Remission (Alternative Definition) at Week 8(Week 8)
- For Cohort 1, Percentage of Participants With Endoscopic Remission at Week 8(Week 8)
- For Cohort 1, Percentage of Participants With MCS Response at Week 8(Week 8)