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

Summary

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.

Timeline

Start

2024-08-07

Primary completion

2029-01-03

Completion

2029-02-06

Publications

• Jairath V, Vuyyuru SK, Zou G, Ma C, Neustifter B, Agboton C, Romo Bautista I, Allocca M, An YK, Begun J, Bryant RV, Danese S, Dubinsky M, Feagan BG, Freire M, Novak KL, Panaccione R, Pudipeddi A, Rubin DT, Sands BE, Sparrow MP, Taylor SA, Gecse KB, Wilkens R, Maaser C. Evaluating treatment to a target of transmural healing in patients with moderately to severely active Crohn's disease: rationale, design and protocol for the randomised controlled VECTORS trial. BMJ Open Gastroenterol. 2026 Feb 20;13(1):e002088. doi: 10.1136/bmjgast-2025-002088.

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