NCT06257706

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

An Interventional Study to Evaluate Treating to a Target of Transmural Healing in Patients With Moderately to Severely Active Crohn's Disease

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: Alimentiv Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Moderately to Severely Active Crohn's Disease
• Crohn Disease
• Disease Crohn

Interventions

Type	Name	Description
BIOLOGICAL	Vedolizumab	All participants will begin a vedolizumab induction regimen of 300 mg IV at Weeks 0, 2, 6, and 10 followed by vedolizumab 300 mg IV every 8 weeks starting at Week 14. Treatment may be modified at Weeks 22, 30, and/or 38 based on the results of the target assessment at each of these time points.

Timeline

• Start date: 2024-08-07
• Primary completion: 2029-01-03
• Completion: 2029-02-06
• First posted: 2024-02-14
• Last updated: 2026-01-15

Locations

69 sites across 13 countries: United States, Australia, Belgium, Canada, Czechia, Denmark, France, Germany, Italy, Netherlands, Poland, Portugal, United Kingdom

Regulatory

• FDA-regulated drug study