A new clinical study validating the first prognostic test for inflammatory bowel disease (IBD) has started in the US.
The study is being jointly funded by the Crohn’s & Colitis Foundation and PredictImmune, a UK developer of prognostic tools for guiding treatment options and improving patient outcomes in immune-mediated diseases.
The PRECIOUS study is a multi-centre, observational study of patients with active Crohn’s disease or ulcerative colitis, who are not receiving systemic steroids, immunomodulators or biologics.
It will recruit up to 200 patients from about 15 centres across the US. The patients recruited by New York University/Bellevue are the first to join the study, which will continue to recruit. Patients’ progress will be tracked up for up to 12 months following initial blood sample collection.
Study patients will be classified at diagnosis into high-risk and low-risk cohorts using PredictImmune’s PredictSURE IBD biomarker.
PredictSURE IBD stratifies patients based on their risk of subsequently experiencing a severe disease course, which is characterised by the requirement for multiple escalations in treatment due to frequently relapsing or chronically active disease.
The study will provide important data towards validation of PredictSURE IBD in a diverse US patient population.
PredictSURE IBD is based on 10 years of extensive research into gene expression profiling of CD8+ T cells by researchers at Professor Ken Smith’s laboratory at the University of Cambridge, UK.
The start of the study follows the recent announcement that PredictImmune has entered into an exclusive commercial partnership with KSL Biomedical (KSL), to promote and provide PredictSURE IBD, throughout North America.