LAST UPDATED
September 11, 2026
Clinicaltrials.gov ID
CTSID
CTSID
OVERVIEW
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 (PALEKONA)
PROTOCOL 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.
View moreParticipation requirements
Age
18 years - 75 years
Sex
All
Healthy Volunteers
No
Age
18 years - 75 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Ulcerative Colitis
Gender
N/A
Date
December 2023 - January 2027
Study Type
Interventional
Study Phase
Phase 2
Product
Tilpisertib Fosmecarbil, Placebo
Eligibility information
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.
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.
Locations
Locations (102)
GastroSb Weight Loss Clinic
Chula Vista, California, United States, 91910
Southern California Research Centers
Coronado, California, United States, 92118
UC San Diego Health System
La Jolla, California, United States, 92037
University of California, Davis
Sacramento, California, United States, 95817
University of California San Francisco
San Francisco, California, United States, 94115
Clinical Research of Osceola
Kissimmee, Florida, United States, 34741
Digestive and Liver Center of Florida, LLC
Orlando, Florida, United States, 32825
Advanced Medical Research Center
Port Orange, Florida, United States, 32127
Gastroenterology Associates of North Mississippi
Oxford, Mississippi, United States, 38655
Digestive Health Specialists
Tupelo, Mississippi, United States, 38801
St. Charles Clinical Research
St Louis, Missouri, United States, 63141
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
Gastroenterology & Hepatology Specialists Inc
Canton, Ohio, United States, 44718
The Ohio State University Wexner Medical Centre
Columbus, Ohio, United States, 43210
Skyline Gastroenterology of West Tennessee
Jackson, Tennessee, United States, 38301
Gastroenterology Research of Hill Country
Boerne, Texas, United States, 78006
Clinical Associates in Research Therapeutics of America
San Antonio, Texas, United States, 78212
Gastroenterology Research of San Antonio
San Antonio, Texas, United States, 78229
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320
Emeritas Group Research
Lansdowne Town Center, Virginia, United States, 20176
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia, United States, 24014
Sunshine Coast University Hospital
Birtinya, Queensland, Australia, 4575
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
University of Salzburg, Universitätsklinik für Innere Medizin III
Salzburg, Austria, 5020
Medical University Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology
Vienna, Austria, 1090
London Health Sciences Centre-University Hospital
London, Canada, N6A 5A5
Charite Universitaetsmedizin Berlin Campus CVK, Department of Hepatology and Gastroenterology
Berlin, Germany, 13353
Universitaetsklinikum Ulm Klinik fur Innere Medizin I CED Studien Ambulanz
Ulm, Germany, 89081
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, Hungary, 1033
AZIENDA UNICA OSPEDALIERO-UNIVERSITARIA"RENATO DULBECCO" - AOU"Mater Domini"
Catanzaro, Italy, 88100
Kitasato University Kitasato Institute Hospital
Minatoku, Japan, 108-8642
Kliniczny Szpital Wojewódzki Nr 2 im. Sw. Jadwigi Królowej w Rzeszowie
Rzeszów, Poland, 35-210
Specjalistyczna Praktyka Lekarska Leszek Bryniarski
Sopot, Poland, 81-756
Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Poland, 00-728
Specjalistyczne Gabinety Lekarskie Body Clinic
Warsaw, Poland, 03-712
Yonsei University Severance Hospital
Seodaemun-Gu, VIC, South Korea, 3772
Intesto, Gastroenterologische Praxis Crohn-Colitis-Zentrum
Bern, Switzerland, 3012
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Norfolk and Norwich University Hospital Nhs Foundation Trust
Norwich, United Kingdom, NR4 7UZ
University Hospital Southampton Nhs Foundation Trust
Southampton, United Kingdom, SO16 6YD
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