This is a multicentre, prospective, randomised, controlled, open-label study to assess the efficacy, safety, and cost-effectiveness of epigenome-guided treatment selection compared to usual standard-of-care (SOC) treatment selection in patients initiating biologic therapy for the treatment of their active Crohn's Disease (CD).
Aged 18 years or older at the time of informed consent.
Documented diagnosis of ileal, ileocolonic, or colonic CD (may be confirmed at baseline study endoscopy).
Active CD, as defined by HBI > 6 and SES-CD ≥ 6 for colitis/ileocolitis and ≥ 4 for ileitis only.
Eligible to receive either VDZ and/or UST therapy for the treatment of CD per the approved drug label requirements and in the opinion of the treating physician.
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.
Ileorectal anastomosis (rectum < 15 cm), or a proctocolectomy.
Short bowel syndrome.
Alimentiv Inc.
Lead sponsor
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborator
Horizon Europe
Collaborator
Stichting Amsterdam UMC
Collaborator