RecruitingPhase 2NCT06029972

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

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

Sponsor

Gilead Sciences

Enrollment

176 participants

Start Date

Dec 5, 2023

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called tilpisertib fosmecarbil for people with moderate to severe ulcerative colitis (UC) — a condition where the lining of the large intestine becomes inflamed, causing abdominal pain, diarrhea, and bleeding. This drug targets a specific inflammatory signaling pathway. This trial is for people who have already tried at least one advanced UC therapy but it either stopped working or didn't work well enough. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed ulcerative colitis of at least 90 days duration, extending at least 15 cm into the colon - Your UC is moderately to severely active based on endoscopy and symptom scores - You have tried at least one advanced therapy for UC (e.g., biologics or JAK inhibitors) but it failed or you lost response **You may NOT be eligible if...** - You have Crohn's disease or colitis limited to the rectum only - You have a current serious infection or recent infection requiring IV antibiotics - You have acute severe or fulminant colitis, or toxic megacolon - You have a history of opportunistic infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTilpisertib Fosmecarbil

Tablets administered orally

DRUGPlacebo

Tablets administered orally

Locations(129)

GI Alliance

Sun City, Arizona, United States

GastroSb Weight Loss Clinic

Chula Vista, California, United States

Southern California Research Centers

Coronado, California, United States

VVCRD Research

Garden Grove, California, United States

UC San Diego Health System

La Jolla, California, United States

Gastro Care Institute

Lancaster, California, United States

Om Research LLC

Lancaster, California, United States

United Medical Doctors

Murrieta, California, United States

University of California, Davis

Sacramento, California, United States

University of California San Francisco

San Francisco, California, United States

Amicis Research Center

Valencia, California, United States

Luna Research

Coral Gables, Florida, United States

University of Florida

Gainesville, Florida, United States

The Medici Medical Research

Hollywood, Florida, United States

Encore Medical Research, LLC

Hollywood, Florida, United States

Clinical Research of Osceola

Kissimmee, Florida, United States

Florida Research Institute

Largo, Florida, United States

Wellness Research Center

Miami, Florida, United States

IMIC Inc

Miami, Florida, United States

Reserka LLC

Miami, Florida, United States

GI PROS Research

Naples, Florida, United States

Clinical One Research

Orlando, Florida, United States

Digestive and Liver Center of Florida, LLC

Orlando, Florida, United States

Advanced Medical Research Center

Port Orange, Florida, United States

Gastroenterology Associates of Florida - GI Alliance

Wellington, Florida, United States

Atlanta Center For Gastroenterology P.C.

Decatur, Georgia, United States

Corewell Health

Grand Rapids, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Gastroenterology Associates of North Mississippi

Oxford, Mississippi, United States

Digestive Health Specialists

Tupelo, Mississippi, United States

St. Charles Clinical Research

St Louis, Missouri, United States

Ellipsis Research Group

Brooklyn, New York, United States

NYU Langone Long Island Clinical Research Associates

Great Neck, New York, United States

Gastroenterology & Hepatology Specialists Inc

Canton, Ohio, United States

Ohio Gastroenterology & Liver Institute

Cincinnati, Ohio, United States

The Ohio State University Wexner Medical Centre

Columbus, Ohio, United States

Dayton Gastroenterology, LLC

Dayton, Ohio, United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, United States

Hightower Clinical

Oklahoma City, Oklahoma, United States

Skyline Gastroenterology of West Tennessee

Jackson, Tennessee, United States

Gastroenterology Research of Hill Country

Boerne, Texas, United States

Gastroenterology Research of America

El Paso, Texas, United States

DHAT Research Institute

Garland, Texas, United States

Southwest Clinical Trials

Houston, Texas, United States

GI Alliance

Lubbock, Texas, United States

GI Associates and Endoscopy Center - GI Alliance

Mansfield, Texas, United States

Clinical Associates in Research Therapeutics of America

San Antonio, Texas, United States

Gastroenterology Research of San Antonio

San Antonio, Texas, United States

Tyler Research Institute, LLC

Tyler, Texas, United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Emeritas Group Research

Lansdowne Town Center, Virginia, United States

Gastroenterology Consultants of Southwest Virginia

Roanoke, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Mater Adult Hospital

South Brisbane, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Queen Elizabeth Hospital

Woodville, South Australia, Australia

Monash Medical Centre

Clayton, Victoria, Australia

Northern Health

Epping, Victoria, Australia

Footscray Hospital

Footscray, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Medical University of Innsbruck

Innsbruck, Austria

University of Salzburg, Universitätsklinik für Innere Medizin III

Salzburg, Austria

Universitätsklinikum St. Pölten

Sankt Pölten, Austria

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

Vienna, Austria

Universitaire Ziekenhuis Leuven

Leuven, Belgium

London Health Sciences Centre-University Hospital

London, Canada

Physician's Clinical Research, Inc. (PCRI)

Toronto, Canada

Mount Sinai Hospital

Toronto, Canada

TDDA Speciality Research

Vaughan, Canada

Centre Hospitalier Universitaire Grenoble

Grenoble, France

Hôpital Claude Huriez

Little Cedex, France

Hopital Saint Eloi

Montpellier, France

Centre Hospitalier Universitaire de Nantes

Nantes, France

Institut des MICI

Neuilly-sur-Seine, France

CHU de Saint Etienne - Hopital Nord

Saint-Etienne, France

Hopital Rangueil

Toulouse, France

CHRU Nancy

Vandœuvre-lès-Nancy, France

Charite Universitaetsmedizin Berlin Campus CVK, Department of Hepatology and Gastroenterology

Berlin, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitatsklinikum Schleswig-Holstein

Kiel, Germany

Eugastro Gmbh

Liepzig, Germany

Universitaetsklinikum Ulm Klinik fur Innere Medizin I CED Studien Ambulanz

Ulm, Germany

Tolna Megye Balassa Janos Korhaz

Beri Balogh, Hungary

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

Budapest, Hungary

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

Catanzaro, Italy

IRCCS Istituto Clinico Humanitas

Milan, Italy

Azienda Ospedaliera San Camillo Forlanini

Roma, Italy

Istituto Clinico Humanitas

Rozzano, Italy

Azienda Sanitaria Universitaria Friuli Centrale

Udine, Italy

Hyogo Medical University Hospital

Hyōgo, Japan

Fukuoka University Hospital

Jonan-ku, Japan

The Jikei University Hospital

Minatoku, Japan

Kitasato University Kitasato Institute Hospital

Minatoku, Japan

Kyorin University Hospital

Mitaka-shi, Japan

Nagasaki University Hospital

Nagasaki, Japan

Ishida Clinic of IBD and Gastroenterology

Ōita, Japan

Saga University Hospital

Sagaken, Japan

Kitasato University Hospital

Sagamihara, Japan

Sapporo Medical University Hospital

Sapporo, Japan

Ginza Central Clinic

Tokyo, Japan

Institute of Science Tokyo Hospital

Toukiyouto, Japan

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

Katowice, Poland

Gabinet Endoskopii Przewodu Pokarmowego

Krakow, Poland

Medrise Sp. z o.o. Centrum Badań Klinicznych

Lublin, Poland

SOLUMED Centrum Medyczne

Poznan, Poland

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

Rzeszów, Poland

Specjalistyczna Praktyka Lekarska Leszek Bryniarski

Sopot, Poland

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

Torun, Poland

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

Warsaw, Poland

Nzoz Vivamed

Warsaw, Poland

Specjalistyczne Gabinety Lekarskie Body Clinic

Warsaw, Poland

Centrum Medyczne Oporow

Wroclaw, Poland

Yonsei University Severance Hospital

Seodaemun-Gu, VIC, South Korea

Inje University

Busan, South Korea

Yeungnam University Hospital

Daegu, South Korea

Kyungpook National University Hospital

Junggu, South Korea

Kyung Hee University Medical Center

Seoul, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Hanyang University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Wonju Severance Christian Hospital

Wŏnju, South Korea

Intesto, Gastroenterologische Praxis Crohn-Colitis-Zentrum

Bern, Switzerland

Fairfield General Hospital

Bury, United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Barts Health NHS Trust

London, United Kingdom

Norfolk and Norwich University Hospital Nhs Foundation Trust

Norwich, United Kingdom

University Hospital Southampton Nhs Foundation Trust

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06029972

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