A Prospective Randomised Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults With CROHN's Disease

Exclusion Criteria17

• Participants who meet any of the following criteria are to be excluded from the study:
• Prior treatment with VDZ or UST.
• Prior treatment with more than 1 advanced therapy (eg, any biologic \[ie, anti- tumour necrosis factor (TNF), anti-interleukin, anti-integrin\]) or advanced oral small molecule \[ie, Janus kinase inhibitor\]) for CD.
• CD-related complications that in the opinion of the investigator would interfere with participation in the study, including but not limited to:
• Ileorectal anastomosis (rectum \< 15 cm), or a proctocolectomy.
• Short bowel syndrome.
• All ostomies.
• Symptomatic strictures in the bowel or symptomatic strictures in the ileum or ileocecal valve that have a stenosis.
• Suspected or diagnosed active intra-abdominal or perianal abscess that have not been appropriately treated.
• History or current diagnosis of ulcerative colitis (unless this diagnosis was made erroneously), indeterminate colitis, idiopathic colitis (ie, colitis not consistent with CD), microscopic colitis, or colonic mucosal dysplasia (excluding dysplasia in resected adenomas).
• Increased risk of infectious complications (eg, recent pyogenic infection, any congenital or acquired immunodeficiency, or past organ, bone marrow, or stem cell transplantation).
• Any topical rectal therapy for treatment of CD within 2 weeks prior to the screening endoscopy.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) as chronic treatment, except for cyclooxygenase-2logic selective NSAIDS (celecoxib).
• Faecal microbiota transplant (includes human microbiota-based therapeutics) within 4 weeks prior to randomisation.
• Any major surgery (in the investigator's opinion) performed within 8 weeks prior to randomisation or planned during the study.
• History of excessive alcohol or drug abuse that, in the opinion of the investigator, may interfere with the participant's ability to comply with the study procedures.
• Serious underlying disease other than CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study or would compromise participant safety (such as history of malignancies, major neurological disorders, any unstable or uncontrolled medical disorder, or any known or suspected contraindication to any of the study biologics according to local prescribing information).