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New pill could tame ulcerative colitis Flare-Ups

NCT ID NCT06029972

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study tests an experimental oral drug called GS-5290 (tilpisertib fosmecarbil) in 176 adults with moderate to severe ulcerative colitis. Participants are randomly assigned to receive either the drug or a placebo for 12 weeks. The main goal is to see if the drug can improve symptoms like diarrhea, bleeding, and inflammation better than placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GS-5290 (tilpisertib fosmecarbil) tablets taken by mouth
What this could lead to
If successful, this could lead to a new oral treatment option for people with moderate to severe ulcerative colitis, helping control symptoms and reduce disease activity.
What could go wrong
This is an early Phase 2 trial with only 176 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 176 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

Contacts and locations

Locations

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

    Catanzaro, 88100, Italy

  • Advanced Medical Research Center

    Port Orange, Florida, 32127, United States

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 00152, Italy

  • Barts Health NHS Trust

    London, E1 2AJ, United Kingdom

  • CHRU Nancy

    Vandœuvre-lès-Nancy, 54500, France

  • CHU de Saint Etienne - Hopital Nord

    Saint-Etienne, 42055, France

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ, United Kingdom

  • Centre Hospitalier Universitaire Grenoble

    Grenoble, 38043, France

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44000, France

  • Centrum Medyczne Oporow

    Wroclaw, 52-416, Poland

  • Charite Universitaetsmedizin Berlin Campus CVK, Department of Hepatology and Gastroenterology

    Berlin, 13353, Germany

  • Clinical Associates in Research Therapeutics of America

    San Antonio, Texas, 78212, United States

  • Clinical One Research

    Orlando, Florida, 32807, United States

  • Clinical Research of Osceola

    Kissimmee, Florida, 34741, United States

  • Corewell Health

    Grand Rapids, Michigan, 49546, United States

  • Digestive Health Specialists

    Tupelo, Mississippi, 38801, United States

  • Digestive and Liver Center of Florida, LLC

    Orlando, Florida, 32825, United States

  • Emeritas Group Research

    Lansdowne Town Center, Virginia, 20176, United States

  • Eugastro Gmbh

    Liepzig, 4103, Germany

  • Fairfield General Hospital

    Bury, BL9 7TD, United Kingdom

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150, Australia

  • Florida Research Institute

    Largo, Florida, 33771, United States

  • Fukuoka University Hospital

    Jonan-ku, 814-0180, Japan

  • GI Alliance

    Sun City, Arizona, 85351, United States

  • GI Alliance

    Lubbock, Texas, 79410, United States

  • GI PROS Research

    Naples, Florida, 34102, United States

  • Gabinet Endoskopii Przewodu Pokarmowego

    Krakow, 31-009, Poland

  • Gastro Care Institute

    Lancaster, California, 93534, United States

  • GastroSb Weight Loss Clinic

    Chula Vista, California, 91910, United States

  • Gastroenterology & Hepatology Specialists Inc

    Canton, Ohio, 44718, United States

  • Gastroenterology Associates of North Mississippi

    Oxford, Mississippi, 38655, United States

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320, United States

  • Gastroenterology Consultants of Southwest Virginia

    Roanoke, Virginia, 24014, United States

  • Gastroenterology Research of Hill Country

    Boerne, Texas, 78006, United States

  • Gastroenterology Research of San Antonio

    San Antonio, Texas, 78229, United States

  • Ginza Central Clinic

    Tokyo, 104-0061, Japan

  • Hanyang University Hospital

    Seoul, 04763, South Korea

  • Hopital Rangueil

    Toulouse, 31059, France

  • Hopital Saint Eloi

    Montpellier, 34295, France

  • Hyogo Medical University Hospital

    Hyōgo, 663-8501, Japan

  • Hôpital Claude Huriez

    Little Cedex, 59037, France

  • IRCCS Istituto Clinico Humanitas

    Milan, 20089, Italy

  • Inje University

    Busan, 48108, South Korea

  • Institut des MICI

    Neuilly-sur-Seine, 92200, France

  • Institute of Science Tokyo Hospital

    Toukiyouto, 113-8519, Japan

  • Intesto, Gastroenterologische Praxis Crohn-Colitis-Zentrum

    Bern, 3012, Switzerland

  • Ishida Clinic of IBD and Gastroenterology

    Ōita, 870-0823, Japan

  • Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Kitasato University Hospital

    Sagamihara, 252-0375, Japan

  • Kitasato University Kitasato Institute Hospital

    Minatoku, 108-8642, Japan

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

    Rzeszów, 35-210, Poland

  • Kyorin University Hospital

    Mitaka-shi, 181-8611, Japan

  • Kyungpook National University Hospital

    Junggu, 41944, South Korea

  • London Health Sciences Centre-University Hospital

    London, N6A 5A5, Canada

  • Luna Research

    Coral Gables, Florida, 33134, United States

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101, Australia

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

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

    Warsaw, 00-728, Poland

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

    Vienna, 1090, Austria

  • Medical University of Innsbruck

    Innsbruck, 6020, Austria

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Medrise Sp. z o.o. Centrum Badań Klinicznych

    Lublin, 20-852, Poland

  • Mount Sinai Hospital

    Toronto, MSG 1X5, Canada

  • NYU Langone Long Island Clinical Research Associates

    Great Neck, New York, 11021, United States

  • Nagasaki University Hospital

    Nagasaki, 852-8501, Japan

  • Norfolk and Norwich University Hospital Nhs Foundation Trust

    Norwich, NR4 7UZ, United Kingdom

  • Northern Health

    Epping, Victoria, 3076, Australia

  • Om Research LLC

    Lancaster, California, 93534, United States

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Queen Elizabeth Hospital

    Woodville, South Australia, 5011, Australia

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • SOLUMED Centrum Medyczne

    Poznan, 60-425, Poland

  • Saga University Hospital

    Sagaken, 849-8501, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sapporo Medical University Hospital

    Sapporo, 060-8543, Japan

  • Skyline Gastroenterology of West Tennessee

    Jackson, Tennessee, 38301, United States

  • Southern California Research Centers

    Coronado, California, 92118, United States

  • Specjalistyczna Praktyka Lekarska Leszek Bryniarski

    Sopot, 81-756, Poland

  • Specjalistyczne Gabinety Lekarskie Body Clinic

    Warsaw, 03-712, Poland

  • St. Charles Clinical Research

    St Louis, Missouri, 63141, United States

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575, Australia

  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

    Budapest, 1033, Hungary

  • TDDA Speciality Research

    Vaughan, L4L 4Y7, Canada

  • The Jikei University Hospital

    Minatoku, 105-8471, Japan

  • The Medici Medical Research

    Hollywood, Florida, 33021, United States

  • The Ohio State University Wexner Medical Centre

    Columbus, Ohio, 43210, United States

  • Tolna Megye Balassa Janos Korhaz

    Beri Balogh, 7100, Hungary

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701, United States

  • UC San Diego Health System

    La Jolla, California, 92037, United States

  • Universitaetsklinikum Ulm Klinik fur Innere Medizin I CED Studien Ambulanz

    Ulm, 89081, Germany

  • Universitaire Ziekenhuis Leuven

    Leuven, 3000, Belgium

  • Universitatsklinikum Schleswig-Holstein

    Kiel, 24105, Germany

  • University Hospital Southampton Nhs Foundation Trust

    Southampton, SO16 6YD, United Kingdom

  • University of California San Francisco

    San Francisco, California, 94115, United States

  • University of California, Davis

    Sacramento, California, 95817, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • University of Salzburg, Universitätsklinik für Innere Medizin III

    Salzburg, 5020, Austria

  • Universitätsklinikum St. Pölten

    Sankt Pölten, 3100, Austria

  • VVCRD Research

    Garden Grove, California, 92845, United States

  • Yeungnam University Hospital

    Daegu, 42415, South Korea

  • Yonsei University Severance Hospital

    Seodaemun-Gu, VIC, 3772, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.