VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Percentage of participants with Corticosteroid-free Endoscopic remission in group 1 and group 2 at week 48 — week 48
Corticosteroid-free is defined as not using corticosteroids at the time of the assessment. Endoscopic remission is defined by a total Simple Endoscopic Score for CD (SES-CD) ≤4 and at least a 2-point reduction versus baseline with no subscore greater than 1 in any individual variable. The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3, with higher scores representing more severe endoscopic disease activity. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. The sum of each variable score ranges from 0 to 15, except for stenosis (ranges from 0 to 11), because 3 represents a stenosis through which a colonoscope cannot be passed and therefore, can only be observed once. Total SES-CD score is then calculated by summing the item scores (range, 0-56 points).
Trial sites (69)
| Facility | City | Region | Status |
|---|---|---|---|
| TLC Clinical Research Inc - Los Angeles | Los Angeles | California | Withdrawn |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | Not Yet Recruiting |
| Houston Methodist Hospital | Houston | Texas | Recruiting |
| Concord Repatriation General Hospital | Concord | New South Wales | Recruiting |
| Mater Misericordiae Ltd | South Brisbane | Queensland | Recruiting |
| Calvary Adelaide Hospital | Adelaide | South Australia | Recruiting |
| Royal Adelaide Hospital | Adelaide | South Australia | Recruiting |
| The Queen Elizabeth Hospital | Woodville | South Australia | Recruiting |
| Northern Hospital Epping | Epping | Victoria | Recruiting |
| Austin Health | Heidelberg | Victoria | Recruiting |
| The Alfred Hospital | Melbourne | Victoria | Recruiting |
| Royal Melbourne Hospital | Melbourne | Victoria | Recruiting |
| Harry Perkins institute of Medical Research - Fiona Stanley Hospital | Murdoch | Western Australia | Recruiting |
| VITAZ - AZ Nikolaas | Sint-Niklaas | Antwerpen | Recruiting |
| Imelda Ziekenhuis Bonheiden | Bonheiden | Antwerp | Recruiting |
| University Hospital Ghent | Ghent | East Flanders | Recruiting |
| UZ Leuven-University Hospital Gasthuisberg | Leuven | Flemish Brabant | Recruiting |
| AZ Delta - Rumbeke Campus | Roeselare | West Flanders | Recruiting |
| ULB Hopital Erasme | Brussels | Belgium | Recruiting |
| University of Calgary | Calgary | Alberta | Recruiting |
| University of Alberta, Dept of Medicine, Division of Gastroenterology | Edmonton | Alberta | Recruiting |
| Viable Clinical Research - Bridgewater | Bridgewater | Nova Scotia | Recruiting |
| LHSC - University Campus | London | Ontario | Recruiting |
| LHSC - Victoria Hospital | London | Ontario | Not Yet Recruiting |
| Toronto Immune and Digestive Health Institute Inc. (TIDHI) | Toronto | Ontario | Recruiting |
| Vojenska nemocnice Brno | Brno | South Moravian | Not Yet Recruiting |
| Fakultni Nemocnice Brno | Brno | South Moravian | Not Yet Recruiting |
| Herlev Hospital | Herlev | Capital Region | Recruiting |
| Nordsjaellands Hospital - Hillerod | Hillerød | Capital Region | Recruiting |
| Bispebjerg Hospital | Copenhagen NV | Capital | Recruiting |
| Hvidovre Hospital | Hvidovre | Capital | Recruiting |
| Aarhus Universitetshospital | Aarhus | Central Denmark | Recruiting |
| Randers Regional Hospital | Randers | Central Denmark | Recruiting |
| Sjaellands Universitets hospitall Koge | Køge | Region Sjælland | Withdrawn |
| Svendborg Hospital | Svendborg | Denmark | Withdrawn |
| Hopital Lyon Sud | Pierre-Bénite | Auvergne-Rhône-Alpes | Recruiting |
| APHM | Marseille | Provence-Alpes-Côte d'Azur Region | Recruiting |
| Groupe Hospitalier Prive Ambroise Pare - Hartmann | Neuilly-sur-Seine | France | Withdrawn |
| Universitatsklinikum Augsburg | Augsburg | Bavaria | Not Yet Recruiting |
| Universitatsklinkum Frankfurt - Goethe Universitat | Frankfurt am Main | Hesse | Withdrawn |
+ 29 more sites — see the full list on the official registry below.
On this site
📄 Entyvio (vedolizumab) drug profile →Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06257706 on ClinicalTrials.gov ↗ ← All trials in Denmark