Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UC Davis UCSD UCSF
Dates
study started
completion around

Description

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.

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

Keywords

Ulcerative Colitis, Colitis, Ulcer, Tilpisertib Fosmecarbil

Eligibility

You can join if…

Open to people ages 18-75

  • 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 CAN'T join 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.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Locations

  • UC San Diego Health System accepting new patients
    La Jolla California 92037 United States
  • University of California, Davis accepting new patients
    Sacramento California 95817 United States
  • University of California San Francisco accepting new patients
    San Francisco California 94115 United States
  • Southern California Research Centers accepting new patients
    Coronado California 92118 United States
  • VVCRD Research accepting new patients
    Garden Grove California 92845 United States
  • GastroSb Weight Loss Clinic accepting new patients
    Chula Vista California 91910 United States
  • Amicis Research Center accepting new patients
    Valencia California 91355 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Related Info
ID
NCT06029972
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 176 study participants
Last Updated