STATUS Recruiting

Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis (PALEKONA)

See if you qualify OR Call 1-833-GIL-EAD 6

STATUS

Recruiting

GILEAD STUDY ID

GS-US-457-6411

See if you qualify OR Call 1-833-GIL-EAD 6

LAST UPDATED

February 11, 2026

Clinicaltrials.gov ID

CTSID

CTSID

STUDY DOCUMENTS

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.

Participation requirements

Age

18 years - 75 years

Sex

All

Healthy Volunteers

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 (129)

GI Alliance

Sun City, Arizona, United States, 85351

Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis (PALEKONA)

OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

Eligibility information

Inclusion criteria

Exclusion criteria

Locations

Locations (129)

GI Alliance

GastroSb Weight Loss Clinic

Southern California Research Centers

VVCRD Research

UC San Diego Health System

Gastro Care Institute

Om Research LLC

United Medical Doctors

University of California, Davis

University of California San Francisco

Amicis Research Center

Luna Research

University of Florida

The Medici Medical Research

Encore Medical Research, LLC

Clinical Research of Osceola

Florida Research Institute

Wellness Research Center

IMIC Inc

Reserka LLC

GI PROS Research

Clinical One Research

Digestive and Liver Center of Florida, LLC

Advanced Medical Research Center

Gastroenterology Associates of Florida - GI Alliance

Atlanta Center For Gastroenterology P.C.

Corewell Health

Mayo Clinic

Gastroenterology Associates of North Mississippi

Digestive Health Specialists

St. Charles Clinical Research

Ellipsis Research Group

NYU Langone Long Island Clinical Research Associates

Gastroenterology & Hepatology Specialists Inc

Ohio Gastroenterology & Liver Institute

The Ohio State University Wexner Medical Centre

Dayton Gastroenterology, LLC

Great Lakes Gastroenterology Research, LLC

Hightower Clinical

Skyline Gastroenterology of West Tennessee

Gastroenterology Research of Hill Country

Gastroenterology Research of America

DHAT Research Institute

Southwest Clinical Trials

GI Alliance

GI Associates and Endoscopy Center - GI Alliance

Clinical Associates in Research Therapeutics of America

Gastroenterology Research of San Antonio

Tyler Research Institute, LLC

Gastroenterology Associates of Tidewater

Emeritas Group Research

Gastroenterology Consultants of Southwest Virginia

Swedish Medical Center

Sunshine Coast University Hospital

Mater Adult Hospital

Princess Alexandra Hospital

Royal Adelaide Hospital

Queen Elizabeth Hospital

Monash Medical Centre

Northern Health

Footscray Hospital

Fiona Stanley Hospital

Medical University of Innsbruck

University of Salzburg, Universitätsklinik für Innere Medizin III

Universitätsklinikum St. Pölten

Medical University Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology

Universitaire Ziekenhuis Leuven

London Health Sciences Centre-University Hospital

Physician's Clinical Research, Inc. (PCRI)

Mount Sinai Hospital