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About
The goal of this study is to learn if GS-1427 is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo (Part 1), and participants treated with GS-1427 or ustekinumab alone with participants treated with GS-1427 in combination with ustekinumab (Part 2).
The primary objectives of this study are:
Part 1: To assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12
Part 2: To assess the efficacy of combination therapy with GS-1427 and ustekinumab, compared with GS-1427 and ustekinumab monotherapies, in achieving clinical response at Week 12
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Individuals have Ulcerative Colitis (UC) of at least 90-days duration before randomization confirmed by endoscopy and histology at any time in the past. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents.
Individuals have UC with minimum disease extent of 15 cm from the anal verge.
Individuals have moderately to severely active UC as determined by endoscopy occurring during screening with a total modified Mayo Clinic Score (mMCS) of 5 to 9 points, including a centrally read endoscopic subscore of at least 2.
Individuals have an inadequate response or loss of response or is intolerant to at least 1 of the following conventional UC treatments
Individuals have an inadequate response or loss of response or are intolerant to:
OR
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Primary purpose
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423 participants in 8 patient groups
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Central trial contact
Gilead Clinical Study Information Center
Data sourced from clinicaltrials.gov
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