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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
PHASE2
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
Oakland, California, United States, 94609
Hialeah, Florida, United States, 33016
Hollywood, Florida, United States, 33021
Miami, Florida, United States, 33183
Tampa, Florida, United States, 33612
Weston, Florida, United States, 33331
Decatur, Georgia, United States, 30033
Shreveport, Louisiana, United States, 71105
Chesterfield, Michigan, United States, 48047
Wyoming, Michigan, United States, 49519
Rochester, Minnesota, United States, 55905
Saint Louis, Missouri, United States, 63141
Brooklyn, New York, United States, 11215
Manhasset, New York, United States, 11030
New York, New York, United States, 10016
Statesville, North Carolina, United States, 28625
Westlake, Ohio, United States, 44145
Hershey, Pennsylvania, United States, 17033
Pottsville, Pennsylvania, United States, 17901
Nashville, Tennessee, United States, 37211
Nashville, Tennessee, United States, 37232
Fredericksburg, Texas, United States, 78624
Houston, Texas, United States, 77074
Mansfield, Texas, United States, 76063
San Antonio, Texas, United States, 78212
San Antonio, Texas, United States, 78229
Tyler, Texas, United States, 75701
Charlottesville, Virginia, United States, 22908
Sydney, New South Wales, Australia, 2109
South Brisbane, Queensland, Australia, 4101
Woolloongabba, Queensland, Australia, 4102
Clayton, Victoria, Australia, 3168
Epping, Victoria, Australia, 3076
Fitzroy, Victoria, Australia, 3065
Footscray, Victoria, Australia, 3011
Vaughan, Canada, L4L 4Y7
Tbilisi, Georgia, 112
Hong Kong, Hong Kong
Busan, Korea, Republic of, 48108
Daegu, Korea, Republic of, 41944
Guri-Si, Korea, Republic of, 471-701
Jongno-Gu, Korea, Republic of, 03181
Nam-Gu, Korea, Republic of, 42415
Seoul, Korea, Republic of, 05505
Seoul, Korea, Republic of, 6351
Wonju, Korea, Republic of, 220-701
Kelantan, Malaysia, 16150
Kota Kinabalu, Malaysia, 88586
Kuantan, Malaysia, 25100
Kuantan, Malaysia, 25200
Selangor, Malaysia, 43000
Chisinau, Moldova, Republic of, MD-2025
Kraków, Poland, 30-082
Kraków, Poland, 31-501
Mazowieckie, Poland, 05-500
Rzeszów, Poland, 35-301
Tychy, Poland, 43-100
Warsaw, Poland, 00-728
Warszawa, Poland, 00-332
Changhua City, Taiwan, 505
Kaohsiung, Taiwan, 807
Taichung, Taiwan, 404327
Taipei, Taiwan, 100
Taipei, Taiwan, 11217
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