*Dose-finding study of SAR443122 in adult patients with ulcerative colitis
Research type
Research Study
Full title
A randomized, double-blind, placebo controlled, dose-finding study to assess the efficacy and safety of SAR443122 in adult patients with moderate to severe ulcerative colitis
IRAS ID
1005627
Contact name
Chloe Outin
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Clinicaltrials.gov Identifier
Research summary
Ulcerative colitis (UC) is a chronic immune-mediated disease of the colon. It is a progressive and disabling condition that is disruptive to the daily life of patients, places considerable demands on healthcare services and is associated with increased healthcare costs. Despite the availability of several treatment options, a significant number of patients are non-responders or partial responders. About 50% of patients will have a relapse each year, and, overall, about 20 to 30% of patients need colectomy to remove part of all of their colon. A lack of universal response, the risks of infection, a requirement for administration via injection, the corticosteroid dependence and the development of antidrug antibodies have created the continuous need for safe and effective oral therapies.
Receptor-interacting serine-threonine protein kinase 1 (RIPK1) is an intracellular protein that participates in the regulation of inflammation and cell death in response to various stimuli. SAR443122 is a novel, potent and selective RIPK1 inhibitor for oral administration. SAR443122 selectively inhibits the kinase function of RIPK1 and results in the inhibition of the production of pro-inflammatory cytokines and necroptotic cell death that are thought to be detrimental to the intestinal cell integrity. The purpose of this study is to show that inhibition of RIPK1 kinase activity with SAR443122 may become a novel treatment option for UC patients by suppressing pro inflammatory cytokine production and inflammatory forms of cell death and therefore re-establish conditions that will lead to healing and maintaining the cell integrity of the intestine.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
22/YH/0249
Date of REC Opinion
7 Sep 2022
REC opinion
Further Information Favourable Opinion