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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
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.
Official registry record
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.
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