Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis
Start Date
12/5/2023
Completion Date
2/1/2028
Summary
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.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
Tilpisertib Fosmecarbil
Placebo
Conditions
Locations
GI Alliance
Sun City, Arizona 85351
United States
GastroSb Weight Loss Clinic
Chula Vista, California 91910
United States
Southern California Research Centers
Coronado, California 92118
United States
VVCRD Research
Garden Grove, California 92845
United States
UC San Diego Health System
La Jolla, California 92037
United States
Gastro Care Institute
Lancaster, California 93534
United States
Om Research LLC
Lancaster, California 93534
United States
United Medical Doctors
Murrieta, California 92563
United States
University of California, Davis
Sacramento, California 95817
United States
University of California San Francisco
San Francisco, California 94115
United States
Amicis Research Center
Valencia, California 91355
United States
Luna Research
Coral Gables, Florida 33134
United States
University of Florida
Gainesville, Florida 32610
United States
The Medici Medical Research
Hollywood, Florida 33021
United States
Encore Medical Research, LLC
Hollywood, Florida 33024
United States
Clinical Research of Osceola
Kissimmee, Florida 34741
United States
Florida Research Institute
Largo, Florida 33771
United States
Wellness Research Center
Miami, Florida 33135
United States
IMIC Inc
Miami, Florida 33176
United States
Reserka LLC
Miami, Florida 33176
United States
GI PROS Research
Naples, Florida 34102
United States
Clinical One Research
Orlando, Florida 32807
United States
Digestive and Liver Center of Florida, LLC
Orlando, Florida 32825
United States
Advanced Medical Research Center
Port Orange, Florida 32127
United States
Gastroenterology Associates of Florida - GI Alliance
Wellington, Florida 33414
United States
Atlanta Center For Gastroenterology P.C.
Decatur, Georgia 30033
United States
Corewell Health
Grand Rapids, Michigan 49546
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Gastroenterology Associates of North Mississippi
Oxford, Mississippi 38655
United States
Digestive Health Specialists
Tupelo, Mississippi 38801
United States
St. Charles Clinical Research
St Louis, Missouri 63141
United States
Ellipsis Research Group
Brooklyn, New York 11215
United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York 11021
United States
Gastroenterology & Hepatology Specialists Inc
Canton, Ohio 44718
United States
Ohio Gastroenterology & Liver Institute
Cincinnati, Ohio 45249
United States
The Ohio State University Wexner Medical Centre
Columbus, Ohio 43210
United States
Dayton Gastroenterology, LLC
Dayton, Ohio 45145
United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio 44060
United States
Hightower Clinical
Oklahoma City, Oklahoma 73134
United States
Skyline Gastroenterology of West Tennessee
Jackson, Tennessee 38301
United States
Gastroenterology Research of Hill Country
Boerne, Texas 78006
United States
Gastroenterology Research of America
El Paso, Texas 79936
United States
DHAT Research Institute
Garland, Texas 75044
United States
Southwest Clinical Trials
Houston, Texas 77074
United States
GI Alliance
Lubbock, Texas 79410
United States
GI Associates and Endoscopy Center - GI Alliance
Mansfield, Texas 76063
United States
Clinical Associates in Research Therapeutics of America
San Antonio, Texas 78212
United States
Gastroenterology Research of San Antonio
San Antonio, Texas 78229
United States
Tyler Research Institute, LLC
Tyler, Texas 75701
United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia 23320
United States
Emeritas Group Research
Lansdowne Town Center, Virginia 20176
United States
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia 24014
United States
Swedish Medical Center
Seattle, Washington 98122
United States
Sunshine Coast University Hospital
Birtinya, Queensland 4575
Australia
Mater Adult Hospital
South Brisbane, Queensland 4101
Australia
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
Australia
Royal Adelaide Hospital
Adelaide, South Australia 5000
Australia
Queen Elizabeth Hospital
Woodville, South Australia 5011
Australia
Monash Medical Centre
Clayton, Victoria 3168
Australia
Northern Health
Epping, Victoria 3076
Australia
Footscray Hospital
Footscray, Victoria 3011
Australia
Fiona Stanley Hospital
Murdoch, Western Australia 6150
Australia
Medical University of Innsbruck
Innsbruck, 6020
Austria
University of Salzburg, Universitätsklinik für Innere Medizin III
Salzburg, 5020
Austria
Universitätsklinikum St. Pölten
Sankt Pölten, 3100
Austria
Medical University Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology
Vienna, 1090
Austria
Universitaire Ziekenhuis Leuven
Leuven, 3000
Belgium
London Health Sciences Centre-University Hospital
London, N6A 5A5
Canada
Physician's Clinical Research, Inc. (PCRI)
Toronto, M2K 2W2
Canada
Mount Sinai Hospital
Toronto, MSG 1X5
Canada
TDDA Speciality Research
Vaughan, L4L 4Y7
Canada
Centre Hospitalier Universitaire Grenoble
Grenoble, 38043
France
Hôpital Claude Huriez
Little Cedex, 59037
France
Hopital Saint Eloi
Montpellier, 34295
France
Centre Hospitalier Universitaire de Nantes
Nantes, 44000
France
Institut des MICI
Neuilly-sur-Seine, 92200
France
CHU de Saint Etienne - Hopital Nord
Saint-Etienne, 42055
France
Hopital Rangueil
Toulouse, 31059
France
CHRU Nancy
Vandœuvre-lès-Nancy, 54500
France
Charite Universitaetsmedizin Berlin Campus CVK, Department of Hepatology and Gastroenterology
Berlin, 13353
Germany
Medizinische Hochschule Hannover
Hanover, 30625
Germany
Universitatsklinikum Schleswig-Holstein
Kiel, 24105
Germany
Eugastro Gmbh
Liepzig, 4103
Germany
Universitaetsklinikum Ulm Klinik fur Innere Medizin I CED Studien Ambulanz
Ulm, 89081
Germany
Tolna Megye Balassa Janos Korhaz
Beri Balogh, 7100
Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, 1033
Hungary
AZIENDA UNICA OSPEDALIERO-UNIVERSITARIA"RENATO DULBECCO" - AOU"Mater Domini"
Catanzaro, 88100
Italy
IRCCS Istituto Clinico Humanitas
Milan, 20089
Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, 00152
Italy
Istituto Clinico Humanitas
Rozzano, 20089
Italy
Azienda Sanitaria Universitaria Friuli Centrale
Udine, 33100
Italy
Hyogo Medical University Hospital
Hyōgo, 663-8501
Japan
Fukuoka University Hospital
Jonan-ku, 814-0180
Japan
The Jikei University Hospital
Minatoku, 105-8471
Japan
Kitasato University Kitasato Institute Hospital
Minatoku, 108-8642
Japan
Kyorin University Hospital
Mitaka-shi, 181-8611
Japan
Nagasaki University Hospital
Nagasaki, 852-8501
Japan
Ishida Clinic of IBD and Gastroenterology
Ōita, 870-0823
Japan
Saga University Hospital
Sagaken, 849-8501
Japan
Kitasato University Hospital
Sagamihara, 252-0375
Japan
Sapporo Medical University Hospital
Sapporo, 060-8543
Japan
Ginza Central Clinic
Tokyo, 104-0061
Japan
Institute of Science Tokyo Hospital
Toukiyouto, 113-8519
Japan
Economicus Sp. z o.o., Niepubliczny Zakład Opieki Zdrowotnej (NZOZ) ALL-MEDICUS
Katowice, 40-659
Poland
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, 31-009
Poland
Medrise Sp. z o.o. Centrum Badań Klinicznych
Lublin, 20-852
Poland
SOLUMED Centrum Medyczne
Poznan, 60-425
Poland
Kliniczny Szpital Wojewódzki Nr 2 im. Sw. Jadwigi Królowej w Rzeszowie
Rzeszów, 35-210
Poland
Specjalistyczna Praktyka Lekarska Leszek Bryniarski
Sopot, 81-756
Poland
GASTROMED Kopon, Zmudzinski i wspolnicy Sp. J. Specialized Center of Gastroenterology and Endoscopy
Torun, 87-100
Poland
Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728
Poland
Nzoz Vivamed
Warsaw, 03-580
Poland
Specjalistyczne Gabinety Lekarskie Body Clinic
Warsaw, 03-712
Poland
Centrum Medyczne Oporow
Wroclaw, 52-416
Poland
Yonsei University Severance Hospital
Seodaemun-Gu, VIC 3772
South Korea
Inje University
Busan, 48108
South Korea
Yeungnam University Hospital
Daegu, 42415
South Korea
Kyungpook National University Hospital
Junggu, 41944
South Korea
Kyung Hee University Medical Center
Seoul, 02447
South Korea
Kangbuk Samsung Hospital
Seoul, 03181
South Korea
Hanyang University Hospital
Seoul, 04763
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Wonju Severance Christian Hospital
Wŏnju, 26426
South Korea
Intesto, Gastroenterologische Praxis Crohn-Colitis-Zentrum
Bern, 3012
Switzerland
Fairfield General Hospital
Bury, BL9 7TD
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
United Kingdom
Barts Health NHS Trust
London, E1 2AJ
United Kingdom
Norfolk and Norwich University Hospital Nhs Foundation Trust
Norwich, NR4 7UZ
United Kingdom
University Hospital Southampton Nhs Foundation Trust
Southampton, SO16 6YD
United Kingdom