A Multicenter, Randomized, Double-blind, 2-Part Phase 2 Study to Evaluate the Efficacy and Safety of GS-1427 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC) Part 1: Placebo-Controlled, Dose-Ranging Study of GS-1427; Part 2: Active-Controlled, Combination Study Evaluating the Efficacy and Safety of GS-1427 in Combination With Ustekinumab Versus GS-1427 or Ustekinumab Monotherapy (SWIFT)
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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Age
18 Years - 75 Years
Sex
All
Healthy Volunteers
No
Medical Condition
Ulcerative Colitis
Gender
N/A
Date
March 2024 - May 2027
Study Type
Interventional
Study Phase
Phase 2
Product
GS-1427, Ustekinumab, Placebo-to-match GS-1427
Camarillo, California, United States, 93010
Garden Grove, California, United States, 92845
Lancaster, California, United States, 93534
Murrieta, California, United States, 92563
Hollywood, Florida, United States, 33021
Weston, Florida, United States, 33331
Chesterfield, Michigan, United States, 48047
Wyoming, Michigan, United States, 49519
Nashville, Tennessee, United States, 37211
Houston, Texas, United States, 77074
San Antonio, Texas, United States, 78229
Tyler, Texas, United States, 75701
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