Study of GS-5290 in Participants With Ulcerative Colitis
Research type
Research Study
Full 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
IRAS ID
1006827
Contact name
Ingrid Chang
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Research summary
Inflammatory bowel diseases (IBD), which include Crohn’s disease (CD) and Ulcerative Colitis (UC), are chronic inflammatory diseases of the gastrointestinal tract characterized by periods of relapses and remissions. In UC, the inflammation is limited to the mucosa of the colon and rectum. Crohn’s disease and UC are thought to result from an inappropriate immune response to intestinal microbiota in genetically susceptible hosts, with environmental factors triggering disease initiation and reactivation. The most common presentations of UC are blood in the stool and diarrhoea.
Moderately to severely active UC represents a serious, life-threatening disease for which new therapies are needed to interrupt the inflammatory process to prevent disease progression, restore quality of life, and reduce the risks of hospitalization and urgent colectomy, as well as long-term risks of colon cancer.
The goal of the study is to demonstrate if GS-5290 is effective and safe in treating people with moderate to severe Ulcerative Colitis. The study will compare people in different treatment groups treated with GS-5290 with people treated with placebo.
GS-5290 or placebo are film coated white tables that will be administered orally at the study site or at the participants’ home. One does per day will be administered by the participants.
Approximately 176 adult participants who meet all eligibility criteria will take part in this study. This study will be done in approximately 125 study sites located in around 15 countries in Asia, Europe, Australia and North America.
The total time participants spend in the study will be a maximum of 64 weeks.REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0011
Date of REC Opinion
19 Oct 2023
REC opinion
Further Information Favourable Opinion