Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis
Recruiting · NCT06029972 · Interventional (participants receive a specific treatment) · Lead sponsor: Gilead Sciences
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboTilpisertib Fosmecarbil
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
- f 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.
Where it is running
60 locations listed across 15 US states.
- 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
- Tolna Megye Balassa Janos Korhaz - Beri Balogh, Hungary
- Charite Universitaetsmedizin Berlin Campus CVK, Department of Hepatology and Gastroenterology - Berlin, Germany
- Intesto, Gastroenterologische Praxis Crohn-Colitis-Zentrum - Bern, Switzerland
- Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak - Budapest, Hungary
- Fairfield General Hospital - Bury, United Kingdom
- Inje University - Busan, South Korea
- Cambridge University Hospitals NHS Foundation Trust - Cambridge, United Kingdom
Showing 60 of 129 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →