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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: 2026-02-11
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
ContactGilead Clinical Study Information Center · contact · GileadClinicalTrials@gilead.com · 1-833-445-3230 (GILEAD-0)
InvestigatorGilead Study Director · study_director, Gilead Sciences
All locations (129)
GI AllianceRecruiting
Sun City, Arizona, United States
GastroSb Weight Loss ClinicRecruiting
Chula Vista, California, United States
Southern California Research CentersRecruiting
Coronado, California, United States
VVCRD ResearchRecruiting
Garden Grove, California, United States
UC San Diego Health SystemRecruiting
La Jolla, California, United States
Gastro Care InstituteRecruiting
Lancaster, California, United States
Om Research LLCRecruiting
Lancaster, California, United States
United Medical DoctorsWithdrawn
Murrieta, California, United States
University of California, DavisRecruiting
Sacramento, California, United States
University of California San FranciscoRecruiting
San Francisco, California, United States
Amicis Research CenterWithdrawn
Valencia, California, United States
Luna ResearchRecruiting
Coral Gables, Florida, United States
University of FloridaRecruiting
Gainesville, Florida, United States
The Medici Medical ResearchRecruiting
Hollywood, Florida, United States
Encore Medical Research, LLCWithdrawn
Hollywood, Florida, United States
Clinical Research of OsceolaRecruiting
Kissimmee, Florida, United States
Florida Research InstituteRecruiting
Largo, Florida, United States
Wellness Research CenterWithdrawn
Miami, Florida, United States
IMIC IncWithdrawn
Miami, Florida, United States
Reserka LLCWithdrawn
Miami, Florida, United States
GI PROS ResearchRecruiting
Naples, Florida, United States
Clinical One ResearchRecruiting
Orlando, Florida, United States
Digestive and Liver Center of Florida, LLCRecruiting
Orlando, Florida, United States
Advanced Medical Research CenterRecruiting
Port Orange, Florida, United States
Gastroenterology Associates of Florida - GI AllianceWithdrawn
Wellington, Florida, United States
Atlanta Center For Gastroenterology P.C.Withdrawn
Decatur, Georgia, United States
Corewell HealthRecruiting
Grand Rapids, Michigan, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Gastroenterology Associates of North MississippiRecruiting
Oxford, Mississippi, United States
Digestive Health SpecialistsRecruiting
Tupelo, Mississippi, United States
St. Charles Clinical ResearchRecruiting
St Louis, Missouri, United States
Ellipsis Research GroupActive Not Recruiting
Brooklyn, New York, United States
NYU Langone Long Island Clinical Research AssociatesRecruiting
Great Neck, New York, United States
Gastroenterology & Hepatology Specialists IncRecruiting
Canton, Ohio, United States
Ohio Gastroenterology & Liver InstituteWithdrawn
Cincinnati, Ohio, United States
The Ohio State University Wexner Medical CentreRecruiting
Columbus, Ohio, United States
Dayton Gastroenterology, LLCRecruiting
Dayton, Ohio, United States
Great Lakes Gastroenterology Research, LLCRecruiting
Mentor, Ohio, United States
Hightower ClinicalWithdrawn
Oklahoma City, Oklahoma, United States
Skyline Gastroenterology of West TennesseeNot Yet Recruiting
Jackson, Tennessee, United States
Gastroenterology Research of Hill CountryRecruiting
Boerne, Texas, United States
Gastroenterology Research of AmericaWithdrawn
El Paso, Texas, United States
DHAT Research InstituteWithdrawn
Garland, Texas, United States
Southwest Clinical TrialsWithdrawn
Houston, Texas, United States
GI AllianceRecruiting
Lubbock, Texas, United States
GI Associates and Endoscopy Center - GI AllianceRecruiting
Mansfield, Texas, United States
Clinical Associates in Research Therapeutics of AmericaRecruiting
San Antonio, Texas, United States
Gastroenterology Research of San AntonioRecruiting
San Antonio, Texas, United States
Tyler Research Institute, LLCRecruiting
Tyler, Texas, United States
Gastroenterology Associates of TidewaterRecruiting
Chesapeake, Virginia, United States
Emeritas Group ResearchRecruiting
Lansdowne Town Center, Virginia, United States
Gastroenterology Consultants of Southwest VirginiaRecruiting
Roanoke, Virginia, United States
Swedish Medical CenterWithdrawn
Seattle, Washington, United States
Sunshine Coast University HospitalRecruiting
Birtinya, Queensland, Australia
Mater Adult HospitalRecruiting
South Brisbane, Queensland, Australia
Princess Alexandra HospitalRecruiting
Woolloongabba, Queensland, Australia
Royal Adelaide HospitalRecruiting
Adelaide, South Australia, Australia
Queen Elizabeth HospitalRecruiting
Woodville, South Australia, Australia
Monash Medical CentreWithdrawn
Clayton, Victoria, Australia
Northern HealthRecruiting
Epping, Victoria, Australia
Footscray HospitalRecruiting
Footscray, Victoria, Australia
Fiona Stanley HospitalRecruiting
Murdoch, Western Australia, Australia
Medical University of InnsbruckRecruiting
Innsbruck, Austria
University of Salzburg, Universitätsklinik für Innere Medizin IIINot Yet Recruiting
Salzburg, Austria
Universitätsklinikum St. PöltenRecruiting
Sankt Pölten, Austria
Medical University Vienna, Department of Internal Medicine III, Division Gastroenterology and HepatologyRecruiting
Vienna, Austria
Universitaire Ziekenhuis LeuvenRecruiting
Leuven, Belgium
London Health Sciences Centre-University HospitalRecruiting
London, Canada
Physician's Clinical Research, Inc. (PCRI)Withdrawn
Toronto, Canada
Mount Sinai HospitalRecruiting
Toronto, Canada
TDDA Speciality ResearchRecruiting
Vaughan, Canada
Centre Hospitalier Universitaire GrenobleRecruiting
Grenoble, France
Hôpital Claude HuriezRecruiting
Little Cedex, France
Hopital Saint EloiRecruiting
Montpellier, France
Centre Hospitalier Universitaire de NantesRecruiting
Nantes, France
Institut des MICIRecruiting
Neuilly-sur-Seine, France
CHU de Saint Etienne - Hopital NordRecruiting
Saint-Etienne, France
Hopital RangueilRecruiting
Toulouse, France
CHRU NancyRecruiting
Vandœuvre-lès-Nancy, France
Charite Universitaetsmedizin Berlin Campus CVK, Department of Hepatology and GastroenterologyNot Yet Recruiting
Berlin, Germany
Medizinische Hochschule HannoverNot Yet Recruiting
Hanover, Germany
Universitatsklinikum Schleswig-HolsteinRecruiting
Kiel, Germany
Eugastro GmbhRecruiting
Liepzig, Germany
Universitaetsklinikum Ulm Klinik fur Innere Medizin I CED Studien AmbulanzNot Yet Recruiting
Ulm, Germany
Tolna Megye Balassa Janos KorhazRecruiting
Beri Balogh, Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett KorhazakRecruiting
Budapest, Hungary
AZIENDA UNICA OSPEDALIERO-UNIVERSITARIA"RENATO DULBECCO" - AOU"Mater Domini"Recruiting
Catanzaro, Italy
IRCCS Istituto Clinico HumanitasRecruiting
Milan, Italy
Azienda Ospedaliera San Camillo ForlaniniRecruiting
Roma, Italy
Istituto Clinico HumanitasRecruiting
Rozzano, Italy
Azienda Sanitaria Universitaria Friuli CentraleWithdrawn
Udine, Italy
Hyogo Medical University HospitalRecruiting
Hyōgo, Japan
Fukuoka University HospitalRecruiting
Jonan-ku, Japan
The Jikei University HospitalRecruiting
Minatoku, Japan
Kitasato University Kitasato Institute HospitalRecruiting
Minatoku, Japan
Kyorin University HospitalRecruiting
Mitaka-shi, Japan
Nagasaki University HospitalRecruiting
Nagasaki, Japan
Ishida Clinic of IBD and GastroenterologyRecruiting
Ōita, Japan
Saga University HospitalRecruiting
Sagaken, Japan
Kitasato University HospitalRecruiting
Sagamihara, Japan
Sapporo Medical University HospitalRecruiting
Sapporo, Japan
Ginza Central ClinicRecruiting
Tokyo, Japan
Institute of Science Tokyo HospitalRecruiting
Toukiyouto, Japan
Economicus Sp. z o.o., Niepubliczny Zakład Opieki Zdrowotnej (NZOZ) ALL-MEDICUSWithdrawn
Katowice, Poland
Gabinet Endoskopii Przewodu PokarmowegoRecruiting
Krakow, Poland
Medrise Sp. z o.o. Centrum Badań KlinicznychNot Yet Recruiting
Lublin, Poland
SOLUMED Centrum MedyczneNot Yet Recruiting
Poznan, Poland
Kliniczny Szpital Wojewódzki Nr 2 im. Sw. Jadwigi Królowej w RzeszowieRecruiting
Rzeszów, Poland
Specjalistyczna Praktyka Lekarska Leszek BryniarskiRecruiting
Sopot, Poland
GASTROMED Kopon, Zmudzinski i wspolnicy Sp. J. Specialized Center of Gastroenterology and EndoscopyRecruiting
Torun, Poland
Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor KierkusRecruiting
Warsaw, Poland
Nzoz VivamedWithdrawn
Warsaw, Poland
Specjalistyczne Gabinety Lekarskie Body ClinicRecruiting
Warsaw, Poland
Centrum Medyczne OporowRecruiting
Wroclaw, Poland
Yonsei University Severance HospitalRecruiting
Seodaemun-Gu, VIC, South Korea
Inje UniversityRecruiting
Busan, South Korea
Yeungnam University HospitalRecruiting
Daegu, South Korea
Kyungpook National University HospitalRecruiting
Junggu, South Korea
Kyung Hee University Medical CenterRecruiting
Seoul, South Korea
Kangbuk Samsung HospitalRecruiting
Seoul, South Korea
Hanyang University HospitalRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Wonju Severance Christian HospitalRecruiting
Wŏnju, South Korea
Intesto, Gastroenterologische Praxis Crohn-Colitis-ZentrumRecruiting
Bern, Switzerland
Fairfield General HospitalRecruiting
Bury, United Kingdom
Cambridge University Hospitals NHS Foundation TrustRecruiting
Cambridge, United Kingdom
Barts Health NHS TrustRecruiting
London, United Kingdom
Norfolk and Norwich University Hospital Nhs Foundation TrustRecruiting
Norwich, United Kingdom
University Hospital Southampton Nhs Foundation TrustRecruiting
Southampton, United Kingdom
Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis · TrialPath