Evaluating novel NOD2 agonists in patients with Crohn's disease v1
Research type
Research Study
Full title
Evaluating the effectiveness of novel NOD2 agonists in a functional in vitro assay using peripheral blood monocytes isolated from whole blood donated by volunteers with Crohn's disease associated NOD2 mutations
IRAS ID
344190
Contact name
David Grainger
Contact email
Sponsor organisation
Imhotex Ltd.
Clinicaltrials.gov Identifier
NBR244, NIHR BioResource Reference Number
Duration of Study in the UK
1 years, 5 months, 0 days
Research summary
This study is designed to test new potential medicines targeting a protein linked with Crohn’s disease.
Crohn’s disease is a chronic condition that affects many people around the world. The disease causes inflammation in the gut, resulting in symptoms including diarrhoea, stomach aches and weight loss. Current treatments include steroid tablets which reduce the inflammation. Sometimes major surgery is required to remove small sections of the affected gut but this is often a temporary fix and the disease reappears within a few years. Whilst the current treatments may help manage the disease, better medicines are needed that can prevent Crohn's disease from recurring.
Approximately one third of patients with Crohn’s disease are known to have inherited a modified form of a gene called NOD2. These changes produce altered forms of the NOD2 protein, which results in the overstimulation of the immune system to natural gut bacteria and ultimately the immune system attacking the gut, causing the symptoms associated with Crohn’s disease.
In this study, the NIHR BioResource will be used to identify volunteers with Crohn’s disease both with and without the known modifications to the NOD2 gene. Volunteers without Crohn’s disease will also be identified. Volunteers will be asked to attend the research site, RxCelerate, to provide a single blood donation after informed consent is obtained. Some of the white blood cells that make up our immune system will be isolated from the blood. These cells will be exposed to several potential new medicines that target NOD2. How these cells respond to these new treatments will be measured and differences due to modification of the NOD2 gene assessed. This analysis will aid identification of the most effective new treatments for further clinical development and is a significant step in developing a new medicine to treat Crohn’s disease in individuals with modified NOD2.
Other than providing a single a blood sample, there is no further involvement for study participants. At the end of the study, participants can, if interested be provided with a short description of the results of the study.
REC name
West of Scotland REC 5
REC reference
24/WS/0072
Date of REC Opinion
4 Jun 2024
REC opinion
Favourable Opinion