A PrOspective RandoMIsed Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults with CROHN’s Disease: OMICROHN (OMICROHN)

Research summary

This study will test if a new software program called EpiPredict can predict which biologic therapy might work best for treating Crohn’s disease (CD). This study will include about 378 participants from 6 countries in Europe, and about 98 participants in the United Kingdom (UK). EpiPredict will predict how well two biologics for CD (vedolizumab and ustekinumab) will work. Both vedolizumab and ustekinumab are approved for use in people with CD as part of their usual care. This study is testing if the EpiPredict software can better identify which of these 2 biologics will work for people with CD than usual care, which would be based on doctor’s medical opinion and guidelines for treating CD. The goal of this study is to see if participant’s epigenome (chemicals in the body which interact with genes and how they are expressed but are not part of the genetic code itself) can predict which biologic will work better and if it can reduce healthcare costs. If the EpiPredict software is better at predicting a biologic that works, it could help doctors choose the right treatment sooner. During screening, a blood sample will be taken to "map" participant’s epigenome. Participants will be randomly assigned to either the EpiPredict treatment or the usual care treatment group. After a screening period of up to 6 weeks, participants will come back to the study site to start the biologic therapy recommended by either the EpiPredict software or the study doctor. This study includes three more visits to the clinic during the treatment observation period. After that, participants will complete online questionnaires about their quality of life, healthcare expenses, and work productivity every six months for the next 18 months. The study is paid for by a Horizon Europe Health Grant from the European Commission and the Helmsley Charitable Trust.

Principal Investigator

Prof Jack Satsangi

Contact us

Email: ctf.research@ouh.nhs.uk

IRAS number

345937