Actively Recruiting
Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis
Led by Gilead Sciences · Updated on 2026-02-11
176
Participants Needed
129
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with placebo. The primary objective of this study is to demonstrate the efficacy of tilpisertib fosmecarbil, compared to placebo control, in achieving Clinical Response at Week 12.
CONDITIONS
Official Title
Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals assigned male at birth, or nonpregnant, nonlactating individuals assigned female at birth, aged 18 to 75 years
- Ulcerative colitis diagnosed for at least 90 days before randomization, confirmed by endoscopy and histology
- Disease extent of at least 15 cm from the anal verge
- Moderately to severely active ulcerative colitis with a modified Mayo Clinic Score of 5 to 9 and an endoscopic subscore of 2 to 3
- Previous treatment with at least one advanced therapy mechanism for ulcerative colitis but failure of no more than 3 different advanced therapies
- Surveillance colonoscopy for dysplasia if indicated by regional guidelines prior to randomization
You will not qualify if you...
- Current diagnosis of Crohn's Disease, indeterminate colitis, lymphocytic or collagenous colitis
- Disease limited to the rectum (ulcerative proctitis) at screening endoscopy
- Ongoing therapy with or prior use of any prohibited medications
- Active clinically significant infection, or infection requiring hospitalization or intravenous anti-infectives within 8 weeks
- Infection requiring oral anti-infective therapy within 6 weeks of randomization
- History of opportunistic infection
- Current diagnosis of acute severe colitis, fulminant colitis, or toxic megacolon
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 129 locations
1
GI Alliance
Sun City, Arizona, United States, 85351
Actively Recruiting
2
GastroSb Weight Loss Clinic
Chula Vista, California, United States, 91910
Actively Recruiting
3
Southern California Research Centers
Coronado, California, United States, 92118
Actively Recruiting
4
VVCRD Research
Garden Grove, California, United States, 92845
Actively Recruiting
5
UC San Diego Health System
La Jolla, California, United States, 92037
Actively Recruiting
6
Gastro Care Institute
Lancaster, California, United States, 93534
Actively Recruiting
7
Om Research LLC
Lancaster, California, United States, 93534
Actively Recruiting
8
United Medical Doctors
Murrieta, California, United States, 92563
Withdrawn
9
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
10
University of California San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
11
Amicis Research Center
Valencia, California, United States, 91355
Withdrawn
12
Luna Research
Coral Gables, Florida, United States, 33134
Actively Recruiting
13
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
14
The Medici Medical Research
Hollywood, Florida, United States, 33021
Actively Recruiting
15
Encore Medical Research, LLC
Hollywood, Florida, United States, 33024
Withdrawn
16
Clinical Research of Osceola
Kissimmee, Florida, United States, 34741
Actively Recruiting
17
Florida Research Institute
Largo, Florida, United States, 33771
Actively Recruiting
18
Wellness Research Center
Miami, Florida, United States, 33135
Withdrawn
19
IMIC Inc
Miami, Florida, United States, 33176
Withdrawn
20
Reserka LLC
Miami, Florida, United States, 33176
Withdrawn
21
GI PROS Research
Naples, Florida, United States, 34102
Actively Recruiting
22
Clinical One Research
Orlando, Florida, United States, 32807
Actively Recruiting
23
Digestive and Liver Center of Florida, LLC
Orlando, Florida, United States, 32825
Actively Recruiting
24
Advanced Medical Research Center
Port Orange, Florida, United States, 32127
Actively Recruiting
25
Gastroenterology Associates of Florida - GI Alliance
Wellington, Florida, United States, 33414
Withdrawn
26
Atlanta Center For Gastroenterology P.C.
Decatur, Georgia, United States, 30033
Withdrawn
27
Corewell Health
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
28
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
29
Gastroenterology Associates of North Mississippi
Oxford, Mississippi, United States, 38655
Actively Recruiting
30
Digestive Health Specialists
Tupelo, Mississippi, United States, 38801
Actively Recruiting
31
St. Charles Clinical Research
St Louis, Missouri, United States, 63141
Actively Recruiting
32
Ellipsis Research Group
Brooklyn, New York, United States, 11215
Active, Not Recruiting
33
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
Actively Recruiting
34
Gastroenterology & Hepatology Specialists Inc
Canton, Ohio, United States, 44718
Actively Recruiting
35
Ohio Gastroenterology & Liver Institute
Cincinnati, Ohio, United States, 45249
Withdrawn
36
The Ohio State University Wexner Medical Centre
Columbus, Ohio, United States, 43210
Actively Recruiting
37
Dayton Gastroenterology, LLC
Dayton, Ohio, United States, 45145
Actively Recruiting
38
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States, 44060
Actively Recruiting
39
Hightower Clinical
Oklahoma City, Oklahoma, United States, 73134
Withdrawn
40
Skyline Gastroenterology of West Tennessee
Jackson, Tennessee, United States, 38301
Not Yet Recruiting
41
Gastroenterology Research of Hill Country
Boerne, Texas, United States, 78006
Actively Recruiting
42
Gastroenterology Research of America
El Paso, Texas, United States, 79936
Withdrawn
43
DHAT Research Institute
Garland, Texas, United States, 75044
Withdrawn
44
Southwest Clinical Trials
Houston, Texas, United States, 77074
Withdrawn
45
GI Alliance
Lubbock, Texas, United States, 79410
Actively Recruiting
46
GI Associates and Endoscopy Center - GI Alliance
Mansfield, Texas, United States, 76063
Actively Recruiting
47
Clinical Associates in Research Therapeutics of America
San Antonio, Texas, United States, 78212
Actively Recruiting
48
Gastroenterology Research of San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
49
Tyler Research Institute, LLC
Tyler, Texas, United States, 75701
Actively Recruiting
50
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320
Actively Recruiting
51
Emeritas Group Research
Lansdowne Town Center, Virginia, United States, 20176
Actively Recruiting
52
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia, United States, 24014
Actively Recruiting
53
Swedish Medical Center
Seattle, Washington, United States, 98122
Withdrawn
54
Sunshine Coast University Hospital
Birtinya, Queensland, Australia, 4575
Actively Recruiting
55
Mater Adult Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
56
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
57
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
58
Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011
Actively Recruiting
59
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Withdrawn
60
Northern Health
Epping, Victoria, Australia, 3076
Actively Recruiting
61
Footscray Hospital
Footscray, Victoria, Australia, 3011
Actively Recruiting
62
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
63
Medical University of Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
64
University of Salzburg, Universitätsklinik für Innere Medizin III
Salzburg, Austria, 5020
Not Yet Recruiting
65
Universitätsklinikum St. Pölten
Sankt Pölten, Austria, 3100
Actively Recruiting
66
Medical University Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology
Vienna, Austria, 1090
Actively Recruiting
67
Universitaire Ziekenhuis Leuven
Leuven, Belgium, 3000
Actively Recruiting
68
London Health Sciences Centre-University Hospital
London, Canada, N6A 5A5
Actively Recruiting
69
Physician's Clinical Research, Inc. (PCRI)
Toronto, Canada, M2K 2W2
Withdrawn
70
Mount Sinai Hospital
Toronto, Canada, MSG 1X5
Actively Recruiting
71
TDDA Speciality Research
Vaughan, Canada, L4L 4Y7
Actively Recruiting
72
Centre Hospitalier Universitaire Grenoble
Grenoble, France, 38043
Actively Recruiting
73
Hôpital Claude Huriez
Little Cedex, France, 59037
Actively Recruiting
74
Hopital Saint Eloi
Montpellier, France, 34295
Actively Recruiting
75
Centre Hospitalier Universitaire de Nantes
Nantes, France, 44000
Actively Recruiting
76
Institut des MICI
Neuilly-sur-Seine, France, 92200
Actively Recruiting
77
CHU de Saint Etienne - Hopital Nord
Saint-Etienne, France, 42055
Actively Recruiting
78
Hopital Rangueil
Toulouse, France, 31059
Actively Recruiting
79
CHRU Nancy
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
80
Charite Universitaetsmedizin Berlin Campus CVK, Department of Hepatology and Gastroenterology
Berlin, Germany, 13353
Not Yet Recruiting
81
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Not Yet Recruiting
82
Universitatsklinikum Schleswig-Holstein
Kiel, Germany, 24105
Actively Recruiting
83
Eugastro Gmbh
Liepzig, Germany, 4103
Actively Recruiting
84
Universitaetsklinikum Ulm Klinik fur Innere Medizin I CED Studien Ambulanz
Ulm, Germany, 89081
Not Yet Recruiting
85
Tolna Megye Balassa Janos Korhaz
Beri Balogh, Hungary, 7100
Actively Recruiting
86
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, Hungary, 1033
Actively Recruiting
87
AZIENDA UNICA OSPEDALIERO-UNIVERSITARIA"RENATO DULBECCO" - AOU"Mater Domini"
Catanzaro, Italy, 88100
Actively Recruiting
88
IRCCS Istituto Clinico Humanitas
Milan, Italy, 20089
Actively Recruiting
89
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy, 00152
Actively Recruiting
90
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
91
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy, 33100
Withdrawn
92
Hyogo Medical University Hospital
Hyōgo, Japan, 663-8501
Actively Recruiting
93
Fukuoka University Hospital
Jonan-ku, Japan, 814-0180
Actively Recruiting
94
The Jikei University Hospital
Minatoku, Japan, 105-8471
Actively Recruiting
95
Kitasato University Kitasato Institute Hospital
Minatoku, Japan, 108-8642
Actively Recruiting
96
Kyorin University Hospital
Mitaka-shi, Japan, 181-8611
Actively Recruiting
97
Nagasaki University Hospital
Nagasaki, Japan, 852-8501
Actively Recruiting
98
Ishida Clinic of IBD and Gastroenterology
Ōita, Japan, 870-0823
Actively Recruiting
99
Saga University Hospital
Sagaken, Japan, 849-8501
Actively Recruiting
100
Kitasato University Hospital
Sagamihara, Japan, 252-0375
Actively Recruiting
101
Sapporo Medical University Hospital
Sapporo, Japan, 060-8543
Actively Recruiting
102
Ginza Central Clinic
Tokyo, Japan, 104-0061
Actively Recruiting
103
Institute of Science Tokyo Hospital
Toukiyouto, Japan, 113-8519
Actively Recruiting
104
Economicus Sp. z o.o., Niepubliczny Zakład Opieki Zdrowotnej (NZOZ) ALL-MEDICUS
Katowice, Poland, 40-659
Withdrawn
105
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, Poland, 31-009
Actively Recruiting
106
Medrise Sp. z o.o. Centrum Badań Klinicznych
Lublin, Poland, 20-852
Not Yet Recruiting
107
SOLUMED Centrum Medyczne
Poznan, Poland, 60-425
Not Yet Recruiting
108
Kliniczny Szpital Wojewódzki Nr 2 im. Sw. Jadwigi Królowej w Rzeszowie
Rzeszów, Poland, 35-210
Actively Recruiting
109
Specjalistyczna Praktyka Lekarska Leszek Bryniarski
Sopot, Poland, 81-756
Actively Recruiting
110
GASTROMED Kopon, Zmudzinski i wspolnicy Sp. J. Specialized Center of Gastroenterology and Endoscopy
Torun, Poland, 87-100
Actively Recruiting
111
Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Poland, 00-728
Actively Recruiting
112
Nzoz Vivamed
Warsaw, Poland, 03-580
Withdrawn
113
Specjalistyczne Gabinety Lekarskie Body Clinic
Warsaw, Poland, 03-712
Actively Recruiting
114
Centrum Medyczne Oporow
Wroclaw, Poland, 52-416
Actively Recruiting
115
Yonsei University Severance Hospital
Seodaemun-Gu, VIC, South Korea, 3772
Actively Recruiting
116
Inje University
Busan, South Korea, 48108
Actively Recruiting
117
Yeungnam University Hospital
Daegu, South Korea, 42415
Actively Recruiting
118
Kyungpook National University Hospital
Junggu, South Korea, 41944
Actively Recruiting
119
Kyung Hee University Medical Center
Seoul, South Korea, 02447
Actively Recruiting
120
Kangbuk Samsung Hospital
Seoul, South Korea, 03181
Actively Recruiting
121
Hanyang University Hospital
Seoul, South Korea, 04763
Actively Recruiting
122
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
123
Wonju Severance Christian Hospital
Wŏnju, South Korea, 26426
Actively Recruiting
124
Intesto, Gastroenterologische Praxis Crohn-Colitis-Zentrum
Bern, Switzerland, 3012
Actively Recruiting
125
Fairfield General Hospital
Bury, United Kingdom, BL9 7TD
Actively Recruiting
126
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
127
Barts Health NHS Trust
London, United Kingdom, E1 2AJ
Actively Recruiting
128
Norfolk and Norwich University Hospital Nhs Foundation Trust
Norwich, United Kingdom, NR4 7UZ
Actively Recruiting
129
University Hospital Southampton Nhs Foundation Trust
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
G
Gilead Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here