Actively Recruiting
VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease
Led by Alimentiv Inc. · Updated on 2026-01-15
304
Participants Needed
69
Research Sites
234 weeks
Total Duration
On this page
Sponsors
A
Alimentiv Inc.
Lead Sponsor
T
Takeda
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Moderately to severely active Crohn's disease with CDAI score 220 to 450 and SES-CD scores excluding severe narrowing
- Bowel wall thickness over 4.0 mm on intestinal ultrasound in the terminal ileum or colon (except rectum)
- Biologic-naive or previous exposure to no more than one advanced therapeutic for Crohn's disease within last 5 years
- Stable dose of 5-ASA for Crohn's disease started at least 4 weeks before screening
- Negative pregnancy test and use of effective contraception for persons who can bear children; documentation if unable to bear children
- Able to fully participate in all study procedures
- Provided written informed consent
You will not qualify if you...
- Previous or current treatment with vedolizumab, etrolizumab, or natalizumab
- Exposure to two or more advanced therapeutic compounds for Crohn's disease
- Recent changes to oral corticosteroid dose within 2 weeks before randomization or corticosteroid dose over 40 mg prednisone equivalent
- Inflammation only proximal to terminal ileum not reachable by ileocolonoscopy
- Complications such as symptomatic strictures with significant prestenotic dilation requiring intervention
- Extensive colonic resection or missing more than two colon segments, ileorectal anastomosis, or proctocolectomy
- Presence of ostomy or ileoanal pouch
- Short bowel syndrome
- Fibrotic-only strictures without active inflammation including impassable stenosis
- Abscess larger than 2 cm detected by ultrasound or endoscopy
- Serious diseases or infections that may affect participation or safety
- Positive Clostridioides difficile stool test
- Known HIV, hepatitis B or C infection without recent negative tests
- Active or latent tuberculosis without recent negative tests
- Other significant systemic or recurring infections within 6 months
- History or signs of progressive multifocal leukoencephalopathy
- Allergy or intolerance to vedolizumab or its components
- Active severe infections such as sepsis or opportunistic infections
- Unwillingness to avoid prohibited medications during the trial
- Participation in another clinical trial or investigational therapy within 30 days
- History of alcohol or drug abuse affecting compliance
- Previous enrollment in this study
- Pregnancy, lactation, or intention to become pregnant/impregnate during or shortly after the study
- Live or live-attenuated vaccination within 4 weeks prior or planned during the study
- Mandatory military service, deprivation of liberty, or judicial limitations
- Immediate family or dependent relationship with study staff involved in this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 69 locations
1
TLC Clinical Research Inc - Los Angeles
Los Angeles, California, United States, 90048
Withdrawn
2
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
3
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
4
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Actively Recruiting
5
Mater Misericordiae Ltd
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
6
Calvary Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
7
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
8
The Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011
Actively Recruiting
9
Northern Hospital Epping
Epping, Victoria, Australia, 3076
Actively Recruiting
10
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
11
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
12
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Actively Recruiting
13
Harry Perkins institute of Medical Research - Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
14
VITAZ - AZ Nikolaas
Sint-Niklaas, Antwerpen, Belgium, 9100
Actively Recruiting
15
Imelda Ziekenhuis Bonheiden
Bonheiden, Antwerp, Belgium, 2820
Actively Recruiting
16
University Hospital Ghent
Ghent, East Flanders, Belgium, 9000
Actively Recruiting
17
UZ Leuven-University Hospital Gasthuisberg
Leuven, Flemish Brabant, Belgium, 3000
Actively Recruiting
18
AZ Delta - Rumbeke Campus
Roeselare, West Flanders, Belgium, 8800
Actively Recruiting
19
ULB Hopital Erasme
Brussels, Belgium, 1070
Actively Recruiting
20
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
Actively Recruiting
21
University of Alberta, Dept of Medicine, Division of Gastroenterology
Edmonton, Alberta, Canada, T6G 2X8
Actively Recruiting
22
Viable Clinical Research - Bridgewater
Bridgewater, Nova Scotia, Canada, B4V 3N2
Actively Recruiting
23
LHSC - University Campus
London, Ontario, Canada, N6A 5A5
Actively Recruiting
24
LHSC - Victoria Hospital
London, Ontario, Canada, N6A 5W9
Not Yet Recruiting
25
Toronto Immune and Digestive Health Institute Inc. (TIDHI)
Toronto, Ontario, Canada
Actively Recruiting
26
Vojenska nemocnice Brno
Brno, South Moravian, Czechia, 615 00
Not Yet Recruiting
27
Fakultni Nemocnice Brno
Brno, South Moravian, Czechia, 625 00
Not Yet Recruiting
28
Herlev Hospital
Herlev, Capital Region, Denmark, 2730
Actively Recruiting
29
Nordsjaellands Hospital - Hillerod
Hillerød, Capital Region, Denmark, 3400
Actively Recruiting
30
Bispebjerg Hospital
Copenhagen NV, Capital, Denmark, 2400
Actively Recruiting
31
Hvidovre Hospital
Hvidovre, Capital, Denmark, 2650
Actively Recruiting
32
Aarhus Universitetshospital
Aarhus, Central Denmark, Denmark, 8200
Actively Recruiting
33
Randers Regional Hospital
Randers, Central Denmark, Denmark, 83930
Actively Recruiting
34
Sjaellands Universitets hospitall Koge
Køge, Region Sjælland, Denmark, 4600
Withdrawn
35
Svendborg Hospital
Svendborg, Denmark
Withdrawn
36
Hopital Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495
Actively Recruiting
37
APHM
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13015
Actively Recruiting
38
Groupe Hospitalier Prive Ambroise Pare - Hartmann
Neuilly-sur-Seine, France
Withdrawn
39
Universitatsklinikum Augsburg
Augsburg, Bavaria, Germany, 86156
Not Yet Recruiting
40
Universitatsklinkum Frankfurt - Goethe Universitat
Frankfurt am Main, Hesse, Germany, 60590
Withdrawn
41
Klinikum Luneburg
Lüneburg, Lower Saxony, Germany, 21339
Actively Recruiting
42
Universitaetsklinikum Schleswig-Holstein (UKSH)- Campus Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Actively Recruiting
43
Universitats Klinikum Freiburg
Freiburg im Breisgau, Germany
Withdrawn
44
Ospedale Casa Sollievo della Sofferenza IRCCS
San Giovanni Rotondo, Foggia, Italy, 71013
Actively Recruiting
45
Ospedale Luigi Sacco
Milan, Lombardy, Italy, 20157
Actively Recruiting
46
Ospedale San Raffaele S.r.I.
Milan, Milan, Italy, 20132
Not Yet Recruiting
47
Policlinico Universitario Agostino Gemelli
Roma, Rome, Italy, 00168
Actively Recruiting
48
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6525
Actively Recruiting
49
Amsterdam UMC - VU Medisch Centrum
Amsterdam, North Holland, Netherlands, 1081HV
Actively Recruiting
50
Erasmus Medisch Centrum (MC)
Rotterdam, South Holland, Netherlands, 3015 GD
Not Yet Recruiting
51
ETZ - St. Elisabeth Hospital
Tilburg, Netherlands
Withdrawn
52
Oddzial Gastroenterologiczny SP ZOZ w Lecznej
Łęczna, Gmina Leczna, Poland, 21-010
Actively Recruiting
53
SOLUMED Centrum Medyczne
Poznan, Greater Poland Voivodeship, Poland, 60-529
Actively Recruiting
54
GASTROMED - Kopon, Zmudzinski I Wspolnicy Sp.j.
Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
Actively Recruiting
55
Melita Medical Sp Zoo
Wroclaw, Lower Silesian Voivodeship, Poland, 53-611
Actively Recruiting
56
Bodyclinic Sp.z.o.o. Sp.K
Warsaw, Masovia, Poland, 03-712
Actively Recruiting
57
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Masovia, Poland, 04-501
Actively Recruiting
58
Centrum Medyczne Medyk
Rzeszów, Podkarpackie Voivodeship, Poland, 35-326
Actively Recruiting
59
Vita Longa Sp. z o.o.
Katowice, Silesian, Poland, 40-748
Actively Recruiting
60
Sonomed Sp. z o.o. - Centrum Medyczne
Szczecin, West Pomerianian, Poland, 71-685
Actively Recruiting
61
Twoja Przychodnia-Centrum Medyczne Opole
Opole, Poland
Withdrawn
62
EuroMediCare (EMC) Instytut Medyczny SA
Wroclaw, Poland, 54-144
Actively Recruiting
63
LisbonCentro Hospitalar Lisboa Norte, EPE- Hospital de Santa Maria
Lisbon, Portugal
Not Yet Recruiting
64
Nottingham University Hospitals NHS Trust - QMC
Nottingham, East Midlands, United Kingdom, NG7 2UH
Actively Recruiting
65
London North West University Healthcare NHS Trust - Northwick Park Hospital
Harrow, Middlesex, United Kingdom, HA1 3UJ
Withdrawn
66
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Not Yet Recruiting
67
Barts Health NHS Trust - The Royal London Hospital
London, United Kingdom, E1 2AJ
Actively Recruiting
68
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2BU
Actively Recruiting
69
Kings College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Actively Recruiting
Research Team
E
Elena van Hest
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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