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NCT06029972PHASE2Recruiting

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

Gilead Sciences

Start Date

12/5/2023

Completion Date

2/1/2028

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 Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

Tilpisertib Fosmecarbil

DRUG

Placebo

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Conditions

Ulcerative Colitis

Locations

GI Alliance

Sun City, Arizona 85351

United States

GastroSb Weight Loss Clinic

Chula Vista, California 91910

United States

Southern California Research Centers

Coronado, California 92118

United States

VVCRD Research

Garden Grove, California 92845

United States

UC San Diego Health System

La Jolla, California 92037

United States

Gastro Care Institute

Lancaster, California 93534

United States

Om Research LLC

Lancaster, California 93534

United States

United Medical Doctors

Murrieta, California 92563

United States

University of California, Davis

Sacramento, California 95817

United States

University of California San Francisco

San Francisco, California 94115

United States

Amicis Research Center

Valencia, California 91355

United States

Luna Research

Coral Gables, Florida 33134

United States

University of Florida

Gainesville, Florida 32610

United States

The Medici Medical Research

Hollywood, Florida 33021

United States

Encore Medical Research, LLC

Hollywood, Florida 33024

United States

Clinical Research of Osceola

Kissimmee, Florida 34741

United States

Florida Research Institute

Largo, Florida 33771

United States

Wellness Research Center

Miami, Florida 33135

United States

IMIC Inc

Miami, Florida 33176

United States

Reserka LLC

Miami, Florida 33176

United States

GI PROS Research

Naples, Florida 34102

United States

Clinical One Research

Orlando, Florida 32807

United States

Digestive and Liver Center of Florida, LLC

Orlando, Florida 32825

United States

Advanced Medical Research Center

Port Orange, Florida 32127

United States

Gastroenterology Associates of Florida - GI Alliance

Wellington, Florida 33414

United States

Atlanta Center For Gastroenterology P.C.

Decatur, Georgia 30033

United States

Corewell Health

Grand Rapids, Michigan 49546

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Gastroenterology Associates of North Mississippi

Oxford, Mississippi 38655

United States

Digestive Health Specialists

Tupelo, Mississippi 38801

United States

St. Charles Clinical Research

St Louis, Missouri 63141

United States

Ellipsis Research Group

Brooklyn, New York 11215

United States

NYU Langone Long Island Clinical Research Associates

Great Neck, New York 11021

United States

Gastroenterology & Hepatology Specialists Inc

Canton, Ohio 44718

United States

Ohio Gastroenterology & Liver Institute

Cincinnati, Ohio 45249

United States

The Ohio State University Wexner Medical Centre

Columbus, Ohio 43210

United States

Dayton Gastroenterology, LLC

Dayton, Ohio 45145

United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio 44060

United States

Hightower Clinical

Oklahoma City, Oklahoma 73134

United States

Skyline Gastroenterology of West Tennessee

Jackson, Tennessee 38301

United States

Gastroenterology Research of Hill Country

Boerne, Texas 78006

United States

Gastroenterology Research of America

El Paso, Texas 79936

United States

DHAT Research Institute

Garland, Texas 75044

United States

Southwest Clinical Trials

Houston, Texas 77074

United States

GI Alliance

Lubbock, Texas 79410

United States

GI Associates and Endoscopy Center - GI Alliance

Mansfield, Texas 76063

United States

Clinical Associates in Research Therapeutics of America

San Antonio, Texas 78212

United States

Gastroenterology Research of San Antonio

San Antonio, Texas 78229

United States

Tyler Research Institute, LLC

Tyler, Texas 75701

United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia 23320

United States

Emeritas Group Research

Lansdowne Town Center, Virginia 20176

United States

Gastroenterology Consultants of Southwest Virginia

Roanoke, Virginia 24014

United States

Swedish Medical Center

Seattle, Washington 98122

United States

Sunshine Coast University Hospital

Birtinya, Queensland 4575

Australia

Mater Adult Hospital

South Brisbane, Queensland 4101

Australia

Princess Alexandra Hospital

Woolloongabba, Queensland 4102

Australia

Royal Adelaide Hospital

Adelaide, South Australia 5000

Australia

Queen Elizabeth Hospital

Woodville, South Australia 5011

Australia

Monash Medical Centre

Clayton, Victoria 3168

Australia

Northern Health

Epping, Victoria 3076

Australia

Footscray Hospital

Footscray, Victoria 3011

Australia

Fiona Stanley Hospital

Murdoch, Western Australia 6150

Australia

Medical University of Innsbruck

Innsbruck, 6020

Austria

University of Salzburg, Universitätsklinik für Innere Medizin III

Salzburg, 5020

Austria

Universitätsklinikum St. Pölten

Sankt Pölten, 3100

Austria

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

Vienna, 1090

Austria

Universitaire Ziekenhuis Leuven

Leuven, 3000

Belgium

London Health Sciences Centre-University Hospital

London, N6A 5A5

Canada

Physician's Clinical Research, Inc. (PCRI)

Toronto, M2K 2W2

Canada

Mount Sinai Hospital

Toronto, MSG 1X5

Canada

TDDA Speciality Research

Vaughan, L4L 4Y7

Canada

Centre Hospitalier Universitaire Grenoble

Grenoble, 38043

France

Hôpital Claude Huriez

Little Cedex, 59037

France

Hopital Saint Eloi

Montpellier, 34295

France

Centre Hospitalier Universitaire de Nantes

Nantes, 44000

France

Institut des MICI

Neuilly-sur-Seine, 92200

France

CHU de Saint Etienne - Hopital Nord

Saint-Etienne, 42055

France

Hopital Rangueil

Toulouse, 31059

France

CHRU Nancy

Vandœuvre-lès-Nancy, 54500

France

Charite Universitaetsmedizin Berlin Campus CVK, Department of Hepatology and Gastroenterology

Berlin, 13353

Germany

Medizinische Hochschule Hannover

Hanover, 30625

Germany

Universitatsklinikum Schleswig-Holstein

Kiel, 24105

Germany

Eugastro Gmbh

Liepzig, 4103

Germany

Universitaetsklinikum Ulm Klinik fur Innere Medizin I CED Studien Ambulanz

Ulm, 89081

Germany

Tolna Megye Balassa Janos Korhaz

Beri Balogh, 7100

Hungary

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

Budapest, 1033

Hungary

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

Catanzaro, 88100

Italy

IRCCS Istituto Clinico Humanitas

Milan, 20089

Italy

Azienda Ospedaliera San Camillo Forlanini

Roma, 00152

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

Azienda Sanitaria Universitaria Friuli Centrale

Udine, 33100

Italy

Hyogo Medical University Hospital

Hyōgo, 663-8501

Japan

Fukuoka University Hospital

Jonan-ku, 814-0180

Japan

The Jikei University Hospital

Minatoku, 105-8471

Japan

Kitasato University Kitasato Institute Hospital

Minatoku, 108-8642

Japan

Kyorin University Hospital

Mitaka-shi, 181-8611

Japan

Nagasaki University Hospital

Nagasaki, 852-8501

Japan

Ishida Clinic of IBD and Gastroenterology

Ōita, 870-0823

Japan

Saga University Hospital

Sagaken, 849-8501

Japan

Kitasato University Hospital

Sagamihara, 252-0375

Japan

Sapporo Medical University Hospital

Sapporo, 060-8543

Japan

Ginza Central Clinic

Tokyo, 104-0061

Japan

Institute of Science Tokyo Hospital

Toukiyouto, 113-8519

Japan

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

Katowice, 40-659

Poland

Gabinet Endoskopii Przewodu Pokarmowego

Krakow, 31-009

Poland

Medrise Sp. z o.o. Centrum Badań Klinicznych

Lublin, 20-852

Poland

SOLUMED Centrum Medyczne

Poznan, 60-425

Poland

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

Rzeszów, 35-210

Poland

Specjalistyczna Praktyka Lekarska Leszek Bryniarski

Sopot, 81-756

Poland

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

Torun, 87-100

Poland

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

Warsaw, 00-728

Poland

Nzoz Vivamed

Warsaw, 03-580

Poland

Specjalistyczne Gabinety Lekarskie Body Clinic

Warsaw, 03-712

Poland

Centrum Medyczne Oporow

Wroclaw, 52-416

Poland

Yonsei University Severance Hospital

Seodaemun-Gu, VIC 3772

South Korea

Inje University

Busan, 48108

South Korea

Yeungnam University Hospital

Daegu, 42415

South Korea

Kyungpook National University Hospital

Junggu, 41944

South Korea

Kyung Hee University Medical Center

Seoul, 02447

South Korea

Kangbuk Samsung Hospital

Seoul, 03181

South Korea

Hanyang University Hospital

Seoul, 04763

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Wonju Severance Christian Hospital

Wŏnju, 26426

South Korea

Intesto, Gastroenterologische Praxis Crohn-Colitis-Zentrum

Bern, 3012

Switzerland

Fairfield General Hospital

Bury, BL9 7TD

United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ

United Kingdom

Barts Health NHS Trust

London, E1 2AJ

United Kingdom

Norfolk and Norwich University Hospital Nhs Foundation Trust

Norwich, NR4 7UZ

United Kingdom

University Hospital Southampton Nhs Foundation Trust

Southampton, SO16 6YD

United Kingdom