RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-05
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06029972

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * 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).
  4. * 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.
  5. * A surveillance colonoscopy for dysplasia is required prior to randomization if indicated by regional guidelines for individuals with UC.
  1. * Current diagnosis of Crohn's Disease (CD) or diagnosis of indeterminate colitis due to an enteric pathogen, lymphocytic or collagenous colitis.
  2. * Individuals with disease limited to the rectum (ulcerative proctitis) during screening endoscopy.
  3. * Requirement for ongoing therapy with or prior use of any prohibited medications.
  4. * Active clinically significant infection, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 8 weeks.
  5. * History of opportunistic infection.
  6. * Current diagnosis of acute severe colitis, fulminant colitis, or toxic megacolon.

Contacts and Locations

Study Contact

Gilead Clinical Study Information Center
CONTACT
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Principal Investigator

Gilead Study Director
STUDY_DIRECTOR
Gilead Sciences

Study Locations (Sites)

Arizona Digestive Health
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
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
Revival Clinical Research
Orlando, Florida, 32807
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
Mayo Clinic
Rochester, Minnesota, 55905
United States
St. Charles Clinical Research
Saint Louis, Missouri, 63141
United States
Ellipsis Research Group
Brooklyn, New York, 11215
United States
Ohio Gastroenterology & Liver Institute
Cincinnati, Ohio, 45249
United States
The Ohio State University Wexner Medical Centre
Columbus, Ohio, 43210
United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
United States
Hightower Clinical
Oklahoma City, Oklahoma, 73134
United States
Hill Country Digestive Health
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
Lubbock Digestive Disease Associates
Lubbock, Texas, 79410
United States
GI Associates and Endoscopy Center - GI Alliance
Mansfield, Texas, 76063
United States
LinQ Research LLC
Pearland, Texas, 77584
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
Swedish Medical Center
Seattle, Washington, 98122
United States

Collaborators and Investigators

Sponsor: Gilead Sciences

  • Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-05
Study Completion Date2027-05

Study Record Updates

Study Start Date2023-12-05
Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

  • Ulcerative Colitis