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Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis

NCT06029972 · Gilead Sciences
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Official title
A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-5290 in Participants With Moderately to Severely Active Ulcerative Colitis
About this study
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
Key Inclusion Criteria: * Individuals assigned male at birth, or nonpregnant, nonlactating individuals assigned female at birth, 18 to 75 years of age based on the date of the screening visit. * Ulcerative colitis (UC) of at least 90-day duration before randomization confirmed by endoscopy and histology at any time in the past AND a minimum disease extent of 15 cm from the anal verge. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents prior to the initiation of screening. * Moderately to severely active UC as determined during screening with a modified Mayo Clinic Score based on the sum of Stool Frequency, Rectal Bleeding, and Endoscopic Finding of 5 to 9 points and an endoscopic subscore of 2 to 3 (determined by central reader). * Previous treatment history of approved UC therapy with at least one advanced therapy mechanisms of action but failure (ie, loss of response or lack of response) of no more than 3 different advanced therapy mechanisms of action. * A surveillance colonoscopy for dysplasia is required prior to randomization if indicated by regional guidelines for individuals with UC. Key Exclusion Criteria: * Current diagnosis of Crohn's Disease (CD) or diagnosis of indeterminate colitis due to an enteric pathogen, lymphocytic or collagenous colitis. * Individuals with disease limited to the rectum (ulcerative proctitis) during screening endoscopy. * Requirement for ongoing therapy with or prior use of any prohibited medications. * Active clinically significant infection, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 8 weeks. of randomization; or any 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. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Study design
Enrollment target: 176 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2023-12-05
Estimated completion: 2028-02
Last updated: 2026-09-11
Interventions
Drug: Tilpisertib FosmecarbilDrug: Placebo
Primary outcomes
  • Proportion of Participants Achieving Clinical Response Per Modified Mayo Clinic Score at Week 12 (Week 12)
Sponsor
Gilead Sciences · industry
Contacts & investigators
InvestigatorGilead Study Director · study_director, Gilead Sciences
All locations (102)
GI Alliance
Sun City, Arizona, United States
GastroSb Weight Loss Clinic
Chula Vista, California, United States
Southern California Research Centers
Coronado, California, United States
VVCRD Research
Garden Grove, California, United States
UC San Diego Health System
La Jolla, California, United States
Gastro Care Institute
Lancaster, California, United States
Om Research LLC
Lancaster, California, United States
University of California, Davis
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
Luna Research
Coral Gables, Florida, United States
University of Florida
Gainesville, Florida, United States
The Medici Medical Research
Hollywood, Florida, United States
Clinical Research of Osceola
Kissimmee, Florida, United States
Florida Research Institute
Largo, Florida, United States
GI PROS Research
Naples, Florida, United States
Clinical One Research
Orlando, Florida, United States
Digestive and Liver Center of Florida, LLC
Orlando, Florida, United States
Advanced Medical Research Center
Port Orange, Florida, United States
Corewell Health
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Gastroenterology Associates of North Mississippi
Oxford, Mississippi, United States
Digestive Health Specialists
Tupelo, Mississippi, United States
St. Charles Clinical Research
St Louis, Missouri, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States
Gastroenterology & Hepatology Specialists Inc
Canton, Ohio, United States
The Ohio State University Wexner Medical Centre
Columbus, Ohio, United States
Skyline Gastroenterology of West Tennessee
Jackson, Tennessee, United States
Gastroenterology Research of Hill Country
Boerne, Texas, United States
GI Alliance
Lubbock, Texas, United States
Clinical Associates in Research Therapeutics of America
San Antonio, Texas, United States
Gastroenterology Research of San Antonio
San Antonio, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Emeritas Group Research
Lansdowne Town Center, Virginia, United States
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia, United States
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Mater Adult Hospital
South Brisbane, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Queen Elizabeth Hospital
Woodville, South Australia, Australia
Northern Health
Epping, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Medical University of Innsbruck
Innsbruck, Austria
University of Salzburg, Universitätsklinik für Innere Medizin III
Salzburg, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, Austria
Medical University Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology
Vienna, Austria
Universitaire Ziekenhuis Leuven
Leuven, Belgium
London Health Sciences Centre-University Hospital
London, Canada
Mount Sinai Hospital
Toronto, Canada
TDDA Speciality Research
Vaughan, Canada
Centre Hospitalier Universitaire Grenoble
Grenoble, France
Hôpital Claude Huriez
Little Cedex, France
Hopital Saint Eloi
Montpellier, France
Centre Hospitalier Universitaire de Nantes
Nantes, France
Institut des MICI
Neuilly-sur-Seine, France
CHU de Saint Etienne - Hopital Nord
Saint-Etienne, France
Hopital Rangueil
Toulouse, France
CHRU Nancy
Vandœuvre-lès-Nancy, France
Charite Universitaetsmedizin Berlin Campus CVK, Department of Hepatology and Gastroenterology
Berlin, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitatsklinikum Schleswig-Holstein
Kiel, Germany
Eugastro Gmbh
Liepzig, Germany
Universitaetsklinikum Ulm Klinik fur Innere Medizin I CED Studien Ambulanz
Ulm, Germany
Tolna Megye Balassa Janos Korhaz
Beri Balogh, Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, Hungary
AZIENDA UNICA OSPEDALIERO-UNIVERSITARIA"RENATO DULBECCO" - AOU"Mater Domini"
Catanzaro, Italy
IRCCS Istituto Clinico Humanitas
Milan, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy
Istituto Clinico Humanitas
Rozzano, Italy
Hyogo Medical University Hospital
Hyōgo, Japan
Fukuoka University Hospital
Jonan-ku, Japan
The Jikei University Hospital
Minatoku, Japan
Kitasato University Kitasato Institute Hospital
Minatoku, Japan
Kyorin University Hospital
Mitaka-shi, Japan
Nagasaki University Hospital
Nagasaki, Japan
Ishida Clinic of IBD and Gastroenterology
Ōita, Japan
Saga University Hospital
Sagaken, Japan
Kitasato University Hospital
Sagamihara, Japan
Sapporo Medical University Hospital
Sapporo, Japan
Ginza Central Clinic
Tokyo, Japan
Institute of Science Tokyo Hospital
Toukiyouto, Japan
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, Poland
Medrise Sp. z o.o. Centrum Badań Klinicznych
Lublin, Poland
SOLUMED Centrum Medyczne
Poznan, Poland
Kliniczny Szpital Wojewódzki Nr 2 im. Sw. Jadwigi Królowej w Rzeszowie
Rzeszów, Poland
Specjalistyczna Praktyka Lekarska Leszek Bryniarski
Sopot, Poland
Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Poland
Specjalistyczne Gabinety Lekarskie Body Clinic
Warsaw, Poland
Centrum Medyczne Oporow
Wroclaw, Poland
Yonsei University Severance Hospital
Seodaemun-Gu, VIC, South Korea
Inje University
Busan, South Korea
Yeungnam University Hospital
Daegu, South Korea
Kyungpook National University Hospital
Junggu, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Hanyang University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Intesto, Gastroenterologische Praxis Crohn-Colitis-Zentrum
Bern, Switzerland
Fairfield General Hospital
Bury, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Norfolk and Norwich University Hospital Nhs Foundation Trust
Norwich, United Kingdom
University Hospital Southampton Nhs Foundation Trust
Southampton, United Kingdom
Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis · TrialPath