Study Details

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

Medical Condition

Ulcerative Colitis

Gender

N/A

Date

December 2023 - April 2026

Study Type

INTERVENTIONAL

Study Phase

PHASE2

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 (108)

Arizona Digestive Health

Sun City, Arizona, United States, 85351

GastroSb Weight Loss Clinic

Chula Vista, California, United States, 91910

Southern California Research Centers

Coronado, California, United States, 92118

VVCRD Research

Garden Grove, California, United States, 92845

UC San Diego Health System

La Jolla, California, United States, 92037

Gastro Care Institute

Lancaster, California, United States, 93534

Om Research LLC

Lancaster, California, United States, 93534

United Medical Doctors

Murrieta, California, United States, 92563

University of California, Davis

Sacramento, California, United States, 95817

University of California San Francisco

San Francisco, California, United States, 94115

Amicis Research Center

Valencia, California, United States, 91355

Luna Research

Coral Gables, Florida, United States, 33134

University of Florida

Gainesville, Florida, United States, 32610

The Medici Medical Research

Hollywood, Florida, United States, 33021

Encore Medical Research, LLC

Hollywood, Florida, United States, 33024

Florida Research Institute

Largo, Florida, United States, 33771

Wellness Research Center

Miami, Florida, United States, 33135

IMIC Inc

Miami, Florida, United States, 33176

Reserka LLC

Miami, Florida, United States, 33176

GI PROS Research

Naples, Florida, United States, 34102

Revival Clinical Research

Orlando, Florida, United States, 32807

Advanced Medical Research Center

Port Orange, Florida, United States, 32127

Gastroenterology Associates of Florida - GI Alliance

Wellington, Florida, United States, 33414

Atlanta Center For Gastroenterology P.C.

Decatur, Georgia, United States, 30033

Mayo Clinic

Rochester, Minnesota, United States, 55905

St. Charles Clinical Research

Saint Louis, Missouri, United States, 63141

Ellipsis Research Group

Brooklyn, New York, United States, 11215

Ohio Gastroenterology & Liver Institute

Cincinnati, Ohio, United States, 45249

The Ohio State University Wexner Medical Centre

Columbus, Ohio, United States, 43210

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, United States, 44060

Hightower Clinical

Oklahoma City, Oklahoma, United States, 73134

Hill Country Digestive Health

Boerne, Texas, United States, 78006

Gastroenterology Research of America

El Paso, Texas, United States, 79936

DHAT Research Institute

Garland, Texas, United States, 75044

Southwest Clinical Trials

Houston, Texas, United States, 77074

Lubbock Digestive Disease Associates

Lubbock, Texas, United States, 79410

GI Associates and Endoscopy Center - GI Alliance

Mansfield, Texas, United States, 76063

LinQ Research LLC

Pearland, Texas, United States, 77584

Clinical Associates in Research Therapeutics of America

San Antonio, Texas, United States, 78212

Gastroenterology Research of San Antonio

San Antonio, Texas, United States, 78229

Swedish Medical Center

Seattle, Washington, United States, 98122

Mater Adult Hospital

South Brisbane, Queensland, Australia, 4101

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4102

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Queen Elizabeth Hospital

Woodville, South Australia, Australia, 5011

Monash Medical Centre

Clayton, Victoria, Australia, 3168

Northern Health

Epping, Victoria, Australia, 3076

Footscray Hospital

Footscray, Victoria, Australia, 3011

Medical University of Innsbruck

Innsbruck, Austria, 6020

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

Vienna, Austria, 1090

Universitaire Ziekenhuis Leuven

Leuven, Belgium, 3000

London Health Sciences Centre-University Hospital

London, Canada, N6A 5A5

Physician's Clinical Research, Inc. (PCRI)

Toronto, Canada, M2K 2W2

Mount Sinai Hospital

Toronto, Canada, MSG 1X5

TDDA Speciality Research

Vaughan, Canada, L4L 4Y7

Centre Hospitalier Universitaire Grenoble

Grenoble Cedex 9, France, 38043

Hôpital Claude Huriez

Little Cedex, France, 59037

Hopital Saint Eloi

Montpellier, France, 34295

Centre Hospitalier Universitaire de Nantes

Nantes, France, 44000

Institut des MICI

Neuilly Sur Seine, France, 92200

CHU de Saint Etienne - Hopital Nord

Saint-Etienne, France, 42055

Hopital Rangueil

Toulouse, France, 31059

CHRU Nancy

Vandoeuvre Les Nancy, France, 54500

Charite Universitaetsmedizin Berlin Campus CVK, Department of Hepatology and Gastroenterology

Berlin, Germany, 13353

Medizinische Hochschule Hannover

Hannover, Germany, 30625

Universitatsklinikum Schleswig-Holstein

Kiel, Germany, 24105

Eugastro Gmbh

Liepzig, Germany, 4103

Tolna Megye Balassa Janos Korhaz

Beri Balogh, Hungary, 7100

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

Budapest, Hungary, 1033

AZIENDA UNICA OSPEDALIERO-UNIVERSITARIA"RENATO DULBECCO" - AOU"Mater Domini"

Catanzaro, Italy, 88100

IRCCS Istituto Clinico Humanitas

Milano, Italy, 20089

Azienda Ospedaliera San Camillo Forlanini

Roma, Italy, 00152

Istituto Clinico Humanitas

Rozzano, Italy, 20089

Hyogo Medical University Hospital

Hyogo, Japan, 663-8501

Fukuoka University Hospital

Jonan-ku, Japan, 814-0180

The Jikei University Hospital

Minato-ku, Japan, 105-8471

Kitasato University Kitasato Institute Hospital

Minato-ku, Japan, 108-8642

Kyorin University Hospital

Mitaka-shi, Japan, 181-8611

Nagasaki University Hospital

Nagasaki, Japan, 852-8501

Ishida Clinic of IBD and Gastroenterology

Oita-shi, Japan, 870-0823

Saga University Hospital

Sagaken, Japan, 849-8501

Kitasato University Hospital

Sagamihara, Japan, 252-0375

Sapporo Medical University Hospital

Sapporo, Japan, 060-8543

Tokyo Medical And Dental University Hospital

Toukiyouto, Japan, 113-8519

Yonsei University Severance Hospital

Seodaemun-Gu, VIC, Korea, Republic of, 3772

Inje University

Busan, Korea, Republic of, 48108

Yeungnam University Hospital

Daegu, Korea, Republic of, 42415

Kyungpook National University Hospital

Jung-gu, Korea, Republic of, 41944

Kyung Hee University Medical Center

Seoul, Korea, Republic of, 02447

Kangbuk Samsung Hospital

Seoul, Korea, Republic of, 03181

Hanyang University Hospital

Seoul, Korea, Republic of, 04763

Samsung Medical Center

Seoul, Korea, Republic of, 06351

Wonju Severance Christian Hospital

Wonju, Korea, Republic of, 26426

Economicus Sp. z o.o., Niepubliczny Zakład Opieki Zdrowotnej (NZOZ) ALL-MEDICUS

Katowice, Poland, 40-659

Gabinet Endoskopii Przewodu Pokarmowego

Krakow, Poland, 31-009

Kliniczny Szpital Wojewódzki Nr 2 im. Sw. Jadwigi Królowej w Rzeszowie

Rzeszów, Poland, 35-210

Specjalistyczna Praktyka Lekarska Leszek Bryniarski

Sopot, Poland, 81-756

GASTROMED Kopon, Zmudzinski i wspolnicy Sp. J. Specialized Center of Gastroenterology and Endoscopy

Torun, Poland, 87-100

Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus

Warszawa, Poland, 00-728

Nzoz Vivamed

Warszawa, Poland, 03-580

Specjalistyczne Gabinety Lekarskie Body Clinic

Warszawa, Poland, 03-712

Centrum Medyczne Oporow

Wroclaw, Poland, 52-416

Intesto, Gastroenterologische Praxis Crohn-Colitis-Zentrum

Bern, Switzerland, 3012

Fairfield General Hospital

Bury, United Kingdom, BL9 7TD

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom, CB2 0QQ

Barts Health NHS Trust

London, United Kingdom, E1 2AJ

Norfolk and Norwich University Hospital Nhs Foundation Trust

Norwich, United Kingdom, NR4 7UZ

University Hospital Southampton Nhs Foundation Trust

Southampton, United Kingdom, SO16 6YD

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

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