Recruiting
Phase 2

Tilpisertib Fosmecarbil

Sponsor:

Gilead Sciences

Code:

NCT06029972

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tilpisertib Fosmecarbil

Placebo

Study Details

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

Study ID

NCT06029972

Start date

Dec 5, 2023

Status verified date

Feb, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

176 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tilpisertib Fosmecarbil Dose A

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.

experimental: Tilpisertib Fosmecarbil Dose B

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.

experimental: Tilpisertib Fosmecarbil Dose C

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.

placebo comparator: Tilpisertib Fosmecarbil Placebo

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.

Interventions

Tilpisertib Fosmecarbil

Tablets administered orally

Placebo

Tablets administered orally

Primary outcome measure

  • Proportion of Participants Achieving Clinical Response Per Modified Mayo Clinic Score at Week 12 [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Gilead Clinical Study Information Center

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

Locations

GI Alliance

Recruiting

Sun City, Arizona, United States, 85351

GastroSb Weight Loss Clinic

Recruiting

Chula Vista, California, United States, 91910

Southern California Research Centers

Recruiting

Coronado, California, United States, 92118

VVCRD Research

Recruiting

Garden Grove, California, United States, 92845

UC San Diego Health System

Recruiting

La Jolla, California, United States, 92037

Gastro Care Institute

Recruiting

Lancaster, California, United States, 93534

Om Research LLC

Recruiting

Lancaster, California, United States, 93534

University of California, Davis

Recruiting

Sacramento, California, United States, 95817

University of California San Francisco

Recruiting

San Francisco, California, United States, 94115

Luna Research

Recruiting

Coral Gables, Florida, United States, 33134

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

The Medici Medical Research

Recruiting

Hollywood, Florida, United States, 33021

Clinical Research of Osceola

Recruiting

Kissimmee, Florida, United States, 34741

Florida Research Institute

Recruiting

Largo, Florida, United States, 33771

GI PROS Research

Recruiting

Naples, Florida, United States, 34102

Clinical One Research

Recruiting

Orlando, Florida, United States, 32807

Digestive and Liver Center of Florida, LLC

Recruiting

Orlando, Florida, United States, 32825

Advanced Medical Research Center

Recruiting

Port Orange, Florida, United States, 32127

Corewell Health

Recruiting

Grand Rapids, Michigan, United States, 49546

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Gastroenterology Associates of North Mississippi

Recruiting

Oxford, Mississippi, United States, 38655

Digestive Health Specialists

Recruiting

Tupelo, Mississippi, United States, 38801

St. Charles Clinical Research

Recruiting

St Louis, Missouri, United States, 63141

NYU Langone Long Island Clinical Research Associates

Recruiting

Great Neck, New York, United States, 11021

Gastroenterology & Hepatology Specialists Inc

Recruiting

Canton, Ohio, United States, 44718

The Ohio State University Wexner Medical Centre

Recruiting

Columbus, Ohio, United States, 43210

Dayton Gastroenterology, LLC

Recruiting

Dayton, Ohio, United States, 45145

Great Lakes Gastroenterology Research, LLC

Recruiting

Mentor, Ohio, United States, 44060

Gastroenterology Research of Hill Country

Recruiting

Boerne, Texas, United States, 78006

GI Alliance

Recruiting

Lubbock, Texas, United States, 79410

GI Associates and Endoscopy Center - GI Alliance

Recruiting

Mansfield, Texas, United States, 76063

Clinical Associates in Research Therapeutics of America

Recruiting

San Antonio, Texas, United States, 78212

Gastroenterology Research of San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Tyler Research Institute, LLC

Recruiting

Tyler, Texas, United States, 75701

Gastroenterology Associates of Tidewater

Recruiting

Chesapeake, Virginia, United States, 23320

Emeritas Group Research

Recruiting

Lansdowne Town Center, Virginia, United States, 20176

Gastroenterology Consultants of Southwest Virginia

Recruiting

Roanoke, Virginia, United States, 24014

London Health Sciences Centre-University Hospital

Recruiting

London, Canada, N6A 5A5

Mount Sinai Hospital

Recruiting

Toronto, Canada, MSG 1X5

TDDA Speciality Research

Recruiting

Vaughan, Canada, L4L 4Y7

More Information

Sponsor

Gilead Sciences

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Gilead Sciences on 2026-02-11.