Cure8 trial brief
This trial tests whether an epigenetic blood test plus decision-support software can guide selection between two approved biologics (vedolizumab and ustekinumab) to improve remission and endoscopic outcomes in Crohn's disease. If successful, it could personalize first-line biologic choices for people starting therapy.
Adults with Crohn's disease starting biologics (VDZ or UST), gastroenterologists and IBD clinicians, and researchers in biomarkers/personalized medicine.
This is a registered, multicenter, randomized, open-label interventional trial comparing epigenome-guided biologic selection versus usual standard-of-care biologic selection for adults with active Crohn's disease who are starting vedolizumab (VDZ) or ustekinumab (UST).
The study uses a hybrid capture–based DNA methylation assay and EpiPredict machine-learning software to predict which of the two biologics has the higher probability of response; investigators receive the single recommended biologic for participants in the epigenome-guided arm.
About the study design: 378 participants will be randomized 1:1 (stratified by prior biologic use and corticosteroid use) and followed for a 26-week primary period with longer-term follow-up to 24 months. Primary outcomes compare corticosteroid-free clinical remission (HBI ≤4) and endoscopic response (≥50% decrease in SES-CD) at Week 26 between arms.
All biologic dosing follows product labels and local standard-of-care. What this does and does not show: The registry entry describes the planned trial design, population, interventions, and predefined outcomes; it does not report results.
It tests whether an epigenetic biomarker plus decision-support software can improve biologic selection for Crohn's disease compared with usual care.
Registry entry describes planned study design and outcomes but does not include results. The methylation assay is for research use and EpiPredict recommends a single biologic to investigators; actual treatment still follows product labels and local SOC.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
People with IBD and their clinicians want ways to predict which advanced therapy will work best. This review summarizes current evidence and shows that, despite many studies, no biomarker is reliably ready for routine...
If validated, blood microRNAs could become noninvasive biomarkers to help track inflammation and predict biochemical response to infliximab or vedolizumab in Crohn’s disease, complementing CRP and fecal calprotectin.
Adherence to biologic therapy can affect how well treatment controls IBD; understanding whether self-administered subcutaneous vedolizumab has different adherence than IV infusion could influence treatment choices and...
