Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis
Condition(s) studied
Investigational drug(s) / intervention(s)
Tilpisertib Fosmecarbil: Tablets administered orally
Placebo: Tablets administered orally
Study 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
Primary outcome measure(s)
- Proportion of Participants Achieving Clinical Response Per Modified Mayo Clinic Score at Week 12 — Week 12
Clinical Response is defined as a decrease from baseline of ≥ 2 points and at least 30% in 3 components of the modified Mayo Clinic Score, Stool Frequency, Rectal Bleeding, and Endoscopic Findings, in addition to a ≥ 1 point decrease from baseline in the Rectal Bleeding subscore or Rectal Bleeding subscore of ≤ 1. The modified Mayo Clinic Score is a scoring system for assessment of UC activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for modified Mayo Clinic Score ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.
Trial sites (102)
| Facility | City | Region | Status |
|---|---|---|---|
| GI Alliance | Sun City | Arizona | |
| GastroSb Weight Loss Clinic | Chula Vista | California | |
| Southern California Research Centers | Coronado | California | |
| VVCRD Research | Garden Grove | California | |
| UC San Diego Health System | La Jolla | California | |
| Gastro Care Institute | Lancaster | California | |
| Om Research LLC | Lancaster | California | |
| University of California, Davis | Sacramento | California | |
| University of California San Francisco | San Francisco | California | |
| Luna Research | Coral Gables | Florida | |
| University of Florida | Gainesville | Florida | |
| The Medici Medical Research | Hollywood | Florida | |
| Clinical Research of Osceola | Kissimmee | Florida | |
| Florida Research Institute | Largo | Florida | |
| GI PROS Research | Naples | Florida | |
| Clinical One Research | Orlando | Florida | |
| Digestive and Liver Center of Florida, LLC | Orlando | Florida | |
| Advanced Medical Research Center | Port Orange | Florida | |
| Corewell Health | Grand Rapids | Michigan | |
| Mayo Clinic | Rochester | Minnesota | |
| Gastroenterology Associates of North Mississippi | Oxford | Mississippi | |
| Digestive Health Specialists | Tupelo | Mississippi | |
| St. Charles Clinical Research | St Louis | Missouri | |
| NYU Langone Long Island Clinical Research Associates | Great Neck | New York | |
| Gastroenterology & Hepatology Specialists Inc | Canton | Ohio | |
| The Ohio State University Wexner Medical Centre | Columbus | Ohio | |
| Skyline Gastroenterology of West Tennessee | Jackson | Tennessee | |
| Gastroenterology Research of Hill Country | Boerne | Texas | |
| GI Alliance | Lubbock | Texas | |
| Clinical Associates in Research Therapeutics of America | San Antonio | Texas | |
| Gastroenterology Research of San Antonio | San Antonio | Texas | |
| Tyler Research Institute, LLC | Tyler | Texas | |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | |
| Emeritas Group Research | Lansdowne Town Center | Virginia | |
| Gastroenterology Consultants of Southwest Virginia | Roanoke | Virginia | |
| Sunshine Coast University Hospital | Birtinya | Queensland | |
| Mater Adult Hospital | South Brisbane | Queensland | |
| Princess Alexandra Hospital | Woolloongabba | Queensland | |
| Royal Adelaide Hospital | Adelaide | South Australia | |
| Queen Elizabeth Hospital | Woodville | South Australia |
+ 62 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06029972 on ClinicalTrials.gov ↗ ← All trials in Italy