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

Recruiting now · Phase 4

Conditions studied: Moderately to Severely Active Crohn's Disease, Crohn Disease, Disease Crohn

In brief

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.

Key facts

Study ID: NCT06257706
Run by: Alimentiv Inc.
People needed: 304
Starts: 2024-08-07
Expected to finish: 2029-02-06
Last updated by the study team: 2026-01-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adults aged 18 to 80 years, inclusive, at the time of consent;
Moderately to severely active CD at baseline defined by a CDAI score of 220 to 450 inclusive and SES-CD, excluding the presence of narrowing component, ≥6 (or ≥4 for participants with isolated ileal disease);
BWT on IUS of >4.0 mm in the terminal ileum or any colonic segment (excluding the rectum) as assessed by the mean of 2 longitudinal and 2 cross-sectional measurements of the same segment;
Biologic-naïve or have previous exposure (within the last 5 years of the screening date) to no more than 1 advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their CD. Note: only approximately 15% to 30% of the enrolled population will have had prior exposure to an advanced therapeutic;
Participants may continue stable dose (initiated at least 4 weeks prior to Screening) of 5-ASA for CD;
Persons of childbearing potential must have a negative serum pregnancy test prior to randomization and must use a highly effective method of contraception throughout the study. Females unable to bear children must have documentation of such in the source records;
Able to participate fully in all aspects of this clinical trial;
Written informed consent must be obtained and documented.

You may not qualify if…

Current or previous treatment with vedolizumab, etrolizumab, or natalizumab;
Previously exposed to 2 or more compounds or classes of an advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their CD;
Change to oral corticosteroid therapy dosing within 2 weeks prior to randomization or a corticosteroid dose of >40 mg of prednisone or equivalent at randomization;
Only have inflammation proximal to the terminal ileum that cannot be reached by ileocolonoscopy;
Have a CD complication, such as symptomatic strictures in the small bowel with >3 cm prestenotic dilatation on any imaging modality, requiring procedural intervention;
Previous extensive colonic resection or missing >2 segments out of 5 (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum), ileorectal anastomosis, or a proctocolectomy;
Ostomy or ileoanal pouch;
Short bowel syndrome;
Fibrotic-only stricture in the ileum or colon without evidence of active inflammation (in the investigator's judgment), including any impassable stenosis;
Abscess >2 cm, detected by IUS or endoscopy; participants with draining fistulas are not excluded;
Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the participant's ability to participate fully in the study or would compromise participant safety;
Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin);
Known HIV or hepatitis B or C infection. If a negative test result is available in the 12 months prior to randomization, retesting is not required;
Known active or latent tuberculosis (TB); if a negative test result is available in the 12 months prior to randomization, confirmatory testing (per standard of care) is not required before randomization;
Other systemic or opportunistic infection (including cytomegalovirus), any other clinically significant extraintestinal infection, or recurring infection within 6 months of randomization;
Has active cerebral/meningeal disease, signs, symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization;
Hypersensitivity, allergy, or intolerance to any excipient of vedolizumab or any other contraindication to vedolizumab;
Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection.
Unwillingness to withhold protocol-prohibited medications during the trial;
Concurrent or previous participation in another clinical trial and received any investigational therapy within 30 days prior to randomization;
History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures;
Prior enrolment in the current study and had received study treatment;
Pregnant, lactating, or intending to become pregnant/impregnate a partner before, during, or within 18 weeks after the last dose; or intending to donate ova or sperm during such time period;
Vaccination with a live or live-attenuated vaccine within 4 weeks prior to randomization, or planned vaccination with a live or live-attenuated vaccine during participation in the study;
Any person performing mandatory military service, deprived of liberty, in a residential care setting, or any person who, due to a judicial decision, cannot take part in clinical studies;

Where it is running

Herlev Hospital — Herlev, Capital Region, Denmark (enrolling)
Nordsjaellands Hospital - Hillerod — Hillerød, Capital Region, Denmark (enrolling)
Concord Repatriation General Hospital — Concord, New South Wales, Australia (enrolling)
Mater Misericordiae Ltd — South Brisbane, Queensland, Australia (enrolling)
Houston Methodist Hospital — Houston, Texas, United States (enrolling)
Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
The Queen Elizabeth Hospital — Woodville, South Australia, Australia (enrolling)
Northern Hospital Epping — Epping, Victoria, Australia (enrolling)
Austin Health — Heidelberg, Victoria, Australia (enrolling)
The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
Calvary Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
Harry Perkins institute of Medical Research - Fiona Stanley Hospital — Murdoch, Western Australia, Australia (enrolling)
VITAZ - AZ Nikolaas — Sint-Niklaas, Antwerpen, Belgium (enrolling)
Imelda Ziekenhuis Bonheiden — Bonheiden, Antwerp, Belgium (enrolling)
University Hospital Ghent — Ghent, East Flanders, Belgium (enrolling)
UZ Leuven-University Hospital Gasthuisberg — Leuven, Flemish Brabant, Belgium (enrolling)
AZ Delta - Rumbeke Campus — Roeselare, West Flanders, Belgium (enrolling)
ULB Hopital Erasme — Brussels, Belgium (enrolling)
University of Calgary — Calgary, Alberta, Canada (enrolling)
University of Alberta, Dept of Medicine, Division of Gastroenterology — Edmonton, Alberta, Canada (enrolling)
Viable Clinical Research - Bridgewater — Bridgewater, Nova Scotia, Canada (enrolling)
LHSC - University Campus — London, Ontario, Canada (enrolling)
Royal Melbourne Hospital — Melbourne, Victoria, Australia (enrolling)
Toronto Immune and Digestive Health Institute Inc. (TIDHI) — Toronto, Ontario, Canada (enrolling)
Bispebjerg Hospital — Copenhagen NV, Capital, Denmark (enrolling)

Full record on ClinicalTrials.gov

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