Gilead Falcon Study
Research type
Research Study
Full title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis
IRAS ID
272325
Contact name
Ian Beales
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2019-001430-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 29 days
Research summary
Summary of Research
This study is to test an experimental drug called GS-4875 in Ulcerative colitis (UC). UC is an inflammatory disease of the large intestine characterised by periods of relapses and remission. UC is thought to result from an inappropriate immune response to intestinal microbiota (bacteria and other organisms) in genetically susceptible people, with environmental factors triggering disease initiation and reactivation. Goals of treatment include improved quality of life, reduction in long-term corticosteroid (a medicine used to lower inflammation) use, and minimisation of cancer risk. Mild to moderately active UC may be treated with oral aminosalicylates, mesalamine, or steroids (all of which are medicines to lower inflammation). For moderately active disease, oral corticosteroids, and immunomodulators (medicines to regulate the immune system) may be used. For more moderately to severely active disease, patients are commonly treated with disease-modifying antirheumatic drugs (to lower inflammation). Despite the number of available therapeutic options for patients with UC, there remains an unmet medical need because existing agents are limited by low efficacy and safety concerns. 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 risk of colorectal cancer. GS-4875 is a first-in-class inhibitor of Tumour progression locus 2 (TPL2) is a substance found in our cells that drives the production of proteins that cause an immune response including inflammation. Therefore, TPL2 inhibition by GS-4875 has the potential to re-establish a proper balance between intestinal microbiota in the gut and the immune system, potentially enabling the resolution of chronic intestinal inflammation in UC patients. Globally the study plans to recruit 180 participants. Participants will be randomly assigned to receive either GS-4875 100mg, GS-4875 300mg or a placebo (a dummy drug that has no medicine).When all randomized subjects have either completed the Blinded Treatment phase Week 10 visit and all associated efficacy and safety assessments,or discontinued the study before Week 10, a Week 10 safety and efficacy analysis will be performed to inform study discontinuation or further development of GS 4875 for the treatment of UC
Summary of Results
The conclusions from Study GS-US-365-4237 are as follows:
-Due to limited participant enrolment in the study, the primary efficacy endpoint, key secondary efficacy endpoints, and exploratory efficacy endpoints were not described in this report.
-Treatment with GS-4875 300-mg and GS-4875 100-mg were well tolerated during the Blinded Treatment phase and GS-4875 300-mg was well tolerated during the OL Treatment phase.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
20/EE/0074
Date of REC Opinion
5 May 2020
REC opinion
Further Information Favourable Opinion