Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT06029972
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
176 participants
INTERVENTIONAL
2023-12-05
2027-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tilpisertib Fosmecarbil Dose A
Blinded Treatment Phase:
Participants will receive tilpisertib fosmecarbil Dose A for up to 12 weeks. An efficacy assessment will be performed at Week 12.
• Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52.
Non-responder Treatment Phase:
• Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose A for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug.
Tilpisertib Fosmecarbil
Tablets administered orally
Tilpisertib Fosmecarbil Dose B
Blinded Treatment Phase:
Participants will receive tilpisertib fosmecarbil Dose B for up to 12 weeks. An efficacy assessment will be performed at Week 12.
• Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52.
Non-responder Treatment Phase:
• Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose B for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug.
Tilpisertib Fosmecarbil
Tablets administered orally
Tilpisertib Fosmecarbil Dose C
Blinded Treatment Phase:
Participants will receive tilpisertib fosmecarbil Dose C for up to 12 weeks. An efficacy assessment will be performed at Week 12.
• Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose C for up to Week 52.
Non-responder Treatment Phase:
• Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose B for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug.
Tilpisertib Fosmecarbil
Tablets administered orally
Tilpisertib Fosmecarbil Placebo
Blinded Treatment Phase:
Participants will receive tilpisertib fosmecarbil placebo for up to 12 weeks. An efficacy assessment will be performed at Week 12.
• Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose C for up to Week 52.
Non-responder Treatment Phase:
• Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose A for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved Clinical Response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve Clinical Response at Non-responder Treatment Phase Week 12 will discontinue study drug.
Tilpisertib Fosmecarbil
Tablets administered orally
Placebo
Tablets administered orally
Interventions
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Tilpisertib Fosmecarbil
Tablets administered orally
Placebo
Tablets administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
United Medical Doctors
Murrieta, California, United States
University of California, Davis
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
Amicis Research Center
Valencia, 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
Encore Medical Research, LLC
Hollywood, Florida, United States
Clinical Research of Osceola
Kissimmee, Florida, United States
Florida Research Institute
Largo, Florida, United States
Wellness Research Center
Miami, Florida, United States
IMIC Inc
Miami, Florida, United States
Reserka LLC
Miami, 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
Gastroenterology Associates of Florida - GI Alliance
Wellington, Florida, United States
Atlanta Center For Gastroenterology P.C.
Decatur, Georgia, 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
Ellipsis Research Group
Brooklyn, New York, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States
Gastroenterology & Hepatology Specialists Inc
Canton, Ohio, United States
Ohio Gastroenterology & Liver Institute
Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Centre
Columbus, Ohio, United States
Dayton Gastroenterology, LLC
Dayton, Ohio, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Skyline Gastroenterology of West Tennessee
Jackson, Tennessee, United States
Gastroenterology Research of Hill Country
Boerne, Texas, United States
Gastroenterology Research of America
El Paso, Texas, United States
DHAT Research Institute
Garland, Texas, United States
Southwest Clinical Trials
Houston, Texas, United States
GI Alliance
Lubbock, Texas, United States
GI Associates and Endoscopy Center - GI Alliance
Mansfield, 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
Swedish Medical Center
Seattle, Washington, 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
Monash Medical Centre
Clayton, Victoria, Australia
Northern Health
Epping, Victoria, Australia
Footscray Hospital
Footscray, 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
Physician's Clinical Research, Inc. (PCRI)
Toronto, , 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
Azienda Sanitaria Universitaria Friuli Centrale
Udine, , 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
Economicus Sp. z o.o., Niepubliczny Zakład Opieki Zdrowotnej (NZOZ) ALL-MEDICUS
Katowice, , Poland
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
GASTROMED Kopon, Zmudzinski i wspolnicy Sp. J. Specialized Center of Gastroenterology and Endoscopy
Torun, , Poland
Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Nzoz Vivamed
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
Kyung Hee University Medical Center
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Hanyang University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Wonju Severance Christian Hospital
Wŏnju, , 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
Countries
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Central Contacts
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Gilead Clinical Study Information Center
Role: CONTACT
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Related Links
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Other Identifiers
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2022-501119-14
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031230403
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-457-6411
Identifier Type: -
Identifier Source: org_study_id