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

NCT06029972 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: GS-US-457-64112022-501119-14jRCT2031230403
• Study Type: interventional
• Target: 176
• Locations: 13 countries
• Sites: 125

Brief 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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Achieving Clinical Response Per Modified Mayo Clinic Score at Week 12

  Clinical Response is defined as a decrease from baseline of ≥ 2 points and at least 30% in 3 components of the modified Mayo Clinic Score, Stool Frequency, Rectal Bleeding, and Endoscopic Findings, in addition to a ≥ 1 point decrease from baseline in the Rectal Bleeding subscore or Rectal Bleeding subscore of ≤ 1. The modified Mayo Clinic Score is a scoring system for assessment of UC activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for modified Mayo Clinic Score ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.

  Week 12

Secondary Outcomes (5)

• Proportion of Participants Achieving Clinical Remission Per Modified Mayo Clinic Score at Week 12

  Week 12

• Proportion of Participants Achieving Endoscopic Response at Week 12

  Week 12

• Proportion of Participants Achieving Histologic Endoscopic Mucosal Improvement at Week 12

  Week 12

• Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

  First dose date up to Week 52 (responders) or Week 64 (non-responders) plus 30 days

• Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities

  First dose date up to Week 52 (responders) or Week 64 (non-responders) plus 30 days

Study Arms (4)

Tilpisertib Fosmecarbil Dose A

EXPERIMENTAL

Blinded Treatment Phase: Participants will receive tilpisertib fosmecarbil Dose A for up to 12 weeks. An efficacy assessment will be performed at Week 12. • Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Non-responder Treatment Phase: • Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose A for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug.

Drug: Tilpisertib Fosmecarbil

Tilpisertib Fosmecarbil Dose B

EXPERIMENTAL

Blinded Treatment Phase: Participants will receive tilpisertib fosmecarbil Dose B for up to 12 weeks. An efficacy assessment will be performed at Week 12. • Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Non-responder Treatment Phase: • Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose B for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug.

Drug: Tilpisertib Fosmecarbil

Tilpisertib Fosmecarbil Dose C

EXPERIMENTAL

Blinded Treatment Phase: Participants will receive tilpisertib fosmecarbil Dose C for up to 12 weeks. An efficacy assessment will be performed at Week 12. • Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose C for up to Week 52. Non-responder Treatment Phase: • Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose B for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug.

Drug: Tilpisertib Fosmecarbil

Tilpisertib Fosmecarbil Placebo

PLACEBO COMPARATOR

Blinded Treatment Phase: Participants will receive tilpisertib fosmecarbil placebo for up to 12 weeks. An efficacy assessment will be performed at Week 12. • Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose C for up to Week 52. Non-responder Treatment Phase: • Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose A for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved Clinical Response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve Clinical Response at Non-responder Treatment Phase Week 12 will discontinue study drug.

Drug: Tilpisertib Fosmecarbil; Drug: Placebo

Interventions

Tilpisertib Fosmecarbil DRUG

Tablets administered orally

Also known as: GS-5290

Tilpisertib Fosmecarbil Dose A; Tilpisertib Fosmecarbil Dose B; Tilpisertib Fosmecarbil Dose C; Tilpisertib Fosmecarbil Placebo

Placebo DRUG

Tablets administered orally

Tilpisertib Fosmecarbil Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (129)

GI Alliance

Sun City, Arizona, 85351, United States

RECRUITING

GastroSb Weight Loss Clinic

Chula Vista, California, 91910, United States

RECRUITING

Southern California Research Centers

Coronado, California, 92118, United States

RECRUITING

VVCRD Research

Garden Grove, California, 92845, United States

RECRUITING

UC San Diego Health System

La Jolla, California, 92037, United States

RECRUITING

Gastro Care Institute

Lancaster, California, 93534, United States

RECRUITING

Om Research LLC

Lancaster, California, 93534, United States

RECRUITING

United Medical Doctors

Murrieta, California, 92563, United States

WITHDRAWN

University of California, Davis

Sacramento, California, 95817, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94115, United States

RECRUITING

Amicis Research Center

Valencia, California, 91355, United States

WITHDRAWN

Luna Research

Coral Gables, Florida, 33134, United States

RECRUITING

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

The Medici Medical Research

Hollywood, Florida, 33021, United States

RECRUITING

Encore Medical Research, LLC

Hollywood, Florida, 33024, United States

WITHDRAWN

Clinical Research of Osceola

Kissimmee, Florida, 34741, United States

RECRUITING

Florida Research Institute

Largo, Florida, 33771, United States

RECRUITING

Wellness Research Center

Miami, Florida, 33135, United States

WITHDRAWN

IMIC Inc

Miami, Florida, 33176, United States

WITHDRAWN

Reserka LLC

Miami, Florida, 33176, United States

WITHDRAWN

GI PROS Research

Naples, Florida, 34102, United States

RECRUITING

Clinical One Research

Orlando, Florida, 32807, United States

RECRUITING

Digestive and Liver Center of Florida, LLC

Orlando, Florida, 32825, United States

RECRUITING

Advanced Medical Research Center

Port Orange, Florida, 32127, United States

RECRUITING

Gastroenterology Associates of Florida - GI Alliance

Wellington, Florida, 33414, United States

WITHDRAWN

Atlanta Center For Gastroenterology P.C.

Decatur, Georgia, 30033, United States

WITHDRAWN

Corewell Health

Grand Rapids, Michigan, 49546, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Gastroenterology Associates of North Mississippi

Oxford, Mississippi, 38655, United States

RECRUITING

Digestive Health Specialists

Tupelo, Mississippi, 38801, United States

RECRUITING

St. Charles Clinical Research

St Louis, Missouri, 63141, United States

RECRUITING

Ellipsis Research Group

Brooklyn, New York, 11215, United States

ACTIVE NOT RECRUITING

NYU Langone Long Island Clinical Research Associates

Great Neck, New York, 11021, United States

RECRUITING

Gastroenterology & Hepatology Specialists Inc

Canton, Ohio, 44718, United States

RECRUITING

Ohio Gastroenterology & Liver Institute

Cincinnati, Ohio, 45249, United States

WITHDRAWN

The Ohio State University Wexner Medical Centre

Columbus, Ohio, 43210, United States

RECRUITING

Dayton Gastroenterology, LLC

Dayton, Ohio, 45145, United States

RECRUITING

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060, United States

RECRUITING

Hightower Clinical

Oklahoma City, Oklahoma, 73134, United States

WITHDRAWN

Skyline Gastroenterology of West Tennessee

Jackson, Tennessee, 38301, United States

NOT YET RECRUITING

Gastroenterology Research of Hill Country

Boerne, Texas, 78006, United States

RECRUITING

Gastroenterology Research of America

El Paso, Texas, 79936, United States

WITHDRAWN

DHAT Research Institute

Garland, Texas, 75044, United States

WITHDRAWN

Southwest Clinical Trials

Houston, Texas, 77074, United States

WITHDRAWN

GI Alliance

Lubbock, Texas, 79410, United States

RECRUITING

GI Associates and Endoscopy Center - GI Alliance

Mansfield, Texas, 76063, United States

RECRUITING

Clinical Associates in Research Therapeutics of America

San Antonio, Texas, 78212, United States

RECRUITING

Gastroenterology Research of San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Tyler Research Institute, LLC

Tyler, Texas, 75701, United States

RECRUITING

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States

RECRUITING

Emeritas Group Research

Lansdowne Town Center, Virginia, 20176, United States

RECRUITING

Gastroenterology Consultants of Southwest Virginia

Roanoke, Virginia, 24014, United States

RECRUITING

Swedish Medical Center

Seattle, Washington, 98122, United States

WITHDRAWN

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

RECRUITING

Mater Adult Hospital

South Brisbane, Queensland, 4101, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

RECRUITING

Monash Medical Centre

Clayton, Victoria, 3168, Australia

WITHDRAWN

Northern Health

Epping, Victoria, 3076, Australia

RECRUITING

Footscray Hospital

Footscray, Victoria, 3011, Australia

RECRUITING

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

RECRUITING

Medical University of Innsbruck

Innsbruck, 6020, Austria

RECRUITING

University of Salzburg, Universitätsklinik für Innere Medizin III

Salzburg, 5020, Austria

NOT YET RECRUITING

Universitätsklinikum St. Pölten

Sankt Pölten, 3100, Austria

RECRUITING

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

Vienna, 1090, Austria

RECRUITING

Universitaire Ziekenhuis Leuven

Leuven, 3000, Belgium

RECRUITING

London Health Sciences Centre-University Hospital

London, N6A 5A5, Canada

RECRUITING

Physician's Clinical Research, Inc. (PCRI)

Toronto, M2K 2W2, Canada

WITHDRAWN

Mount Sinai Hospital

Toronto, MSG 1X5, Canada

RECRUITING

TDDA Speciality Research

Vaughan, L4L 4Y7, Canada

RECRUITING

Centre Hospitalier Universitaire Grenoble

Grenoble, 38043, France

RECRUITING

Hôpital Claude Huriez

Little Cedex, 59037, France

RECRUITING

Hopital Saint Eloi

Montpellier, 34295, France

RECRUITING

Centre Hospitalier Universitaire de Nantes

Nantes, 44000, France

RECRUITING

Institut des MICI

Neuilly-sur-Seine, 92200, France

RECRUITING

CHU de Saint Etienne - Hopital Nord

Saint-Etienne, 42055, France

RECRUITING

Hopital Rangueil

Toulouse, 31059, France

RECRUITING

CHRU Nancy

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Charite Universitaetsmedizin Berlin Campus CVK, Department of Hepatology and Gastroenterology

Berlin, 13353, Germany

NOT YET RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

NOT YET RECRUITING

Universitatsklinikum Schleswig-Holstein

Kiel, 24105, Germany

RECRUITING

Eugastro Gmbh

Liepzig, 4103, Germany

RECRUITING

Universitaetsklinikum Ulm Klinik fur Innere Medizin I CED Studien Ambulanz

Ulm, 89081, Germany

NOT YET RECRUITING

Tolna Megye Balassa Janos Korhaz

Beri Balogh, 7100, Hungary

RECRUITING

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

Budapest, 1033, Hungary

RECRUITING

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

Catanzaro, 88100, Italy

RECRUITING

IRCCS Istituto Clinico Humanitas

Milan, 20089, Italy

RECRUITING

Azienda Ospedaliera San Camillo Forlanini

Roma, 00152, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano, 20089, Italy

RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale

Udine, 33100, Italy

WITHDRAWN

Hyogo Medical University Hospital

Hyōgo, 663-8501, Japan

RECRUITING

Fukuoka University Hospital

Jonan-ku, 814-0180, Japan

RECRUITING

The Jikei University Hospital

Minatoku, 105-8471, Japan

RECRUITING

Kitasato University Kitasato Institute Hospital

Minatoku, 108-8642, Japan

RECRUITING

Kyorin University Hospital

Mitaka-shi, 181-8611, Japan

RECRUITING

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

RECRUITING

Ishida Clinic of IBD and Gastroenterology

Ōita, 870-0823, Japan

RECRUITING

Saga University Hospital

Sagaken, 849-8501, Japan

RECRUITING

Kitasato University Hospital

Sagamihara, 252-0375, Japan

RECRUITING

Sapporo Medical University Hospital

Sapporo, 060-8543, Japan

RECRUITING

Ginza Central Clinic

Tokyo, 104-0061, Japan

RECRUITING

Institute of Science Tokyo Hospital

Toukiyouto, 113-8519, Japan

RECRUITING

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

Katowice, 40-659, Poland

WITHDRAWN

Gabinet Endoskopii Przewodu Pokarmowego

Krakow, 31-009, Poland

RECRUITING

Medrise Sp. z o.o. Centrum Badań Klinicznych

Lublin, 20-852, Poland

NOT YET RECRUITING

SOLUMED Centrum Medyczne

Poznan, 60-425, Poland

NOT YET RECRUITING

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

Rzeszów, 35-210, Poland

RECRUITING

Specjalistyczna Praktyka Lekarska Leszek Bryniarski

Sopot, 81-756, Poland

RECRUITING

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

Torun, 87-100, Poland

RECRUITING

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

Warsaw, 00-728, Poland

RECRUITING

Nzoz Vivamed

Warsaw, 03-580, Poland

WITHDRAWN

Specjalistyczne Gabinety Lekarskie Body Clinic

Warsaw, 03-712, Poland

RECRUITING

Centrum Medyczne Oporow

Wroclaw, 52-416, Poland

RECRUITING

Yonsei University Severance Hospital

Seodaemun-Gu, VIC, 3772, South Korea

RECRUITING

Inje University

Busan, 48108, South Korea

RECRUITING

Yeungnam University Hospital

Daegu, 42415, South Korea

RECRUITING

Kyungpook National University Hospital

Junggu, 41944, South Korea

RECRUITING

Kyung Hee University Medical Center

Seoul, 02447, South Korea

RECRUITING

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

RECRUITING

Hanyang University Hospital

Seoul, 04763, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

RECRUITING

Intesto, Gastroenterologische Praxis Crohn-Colitis-Zentrum

Bern, 3012, Switzerland

RECRUITING

Fairfield General Hospital

Bury, BL9 7TD, United Kingdom

RECRUITING

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Barts Health NHS Trust

London, E1 2AJ, United Kingdom

RECRUITING

Norfolk and Norwich University Hospital Nhs Foundation Trust

Norwich, NR4 7UZ, United Kingdom

RECRUITING

University Hospital Southampton Nhs Foundation Trust

Southampton, SO16 6YD, United Kingdom

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0); GileadClinicalTrials@gilead.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: December 5, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (9); US (53); AU (9); IT (5); JP (12); CH (1); FR (8); DE (5); GB (5); HU (2); PL (11); BE (1); CA (4)