VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease

Transmural healing (TMH) is recognized as a potentially important measure of Crohn's disease (CD) activity but not a formal target. Observational studies suggest that TMH may be associated with better long-term outcomes. The study will evaluate TMH using noninvasive intestinal ultrasound (IUS), a patient-friendly technique that can be performed routinely in clinical practice. The aim of the study is to determine if treating to a target of corticosteroid-free (CS-free) IUS outcomes + clinical symptoms + biomarkers is superior to a target of clinical symptoms + biomarkers alone in achieving CS-free endoscopic remission measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD). Qualified participants will be randomly assigned in a 1:1 ratio to one of 2 different target treatment groups. Group 1: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission. At Week 22 and 30, the IUS-based component of the target will be IUS response and at Week 38, the final treatment target will be TMH. Group 2: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission.

NCT Number	NCT06257706
Lead Sponsor	Alimentiv Inc. Collaborators: Takeda
Conditions	Moderately to Severely Active Crohn's Disease, Crohn Disease, Disease Crohn
Enrollment	304 participants
Start Date	2024-08-07
Primary Completion	2029-01-03 (estimated)
Study Completion	2029-02-06 (estimated)
Updated on ClinicalTrials.gov	2026-01-15