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

What this study 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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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;

+ 6 more criteria — see the full checklist in the app.

Where this trial is running

• TLC Clinical Research Inc - Los Angeles, Los Angeles, California, United States
• Medical University of South Carolina (MUSC), Charleston, South Carolina, United States
• Houston Methodist Hospital, Houston, Texas, United States
• Concord Repatriation General Hospital, Concord, New South Wales, Australia
• Mater Misericordiae Ltd, South Brisbane, Queensland, Australia
• Calvary Adelaide Hospital, Adelaide, South Australia, Australia
• Royal Adelaide Hospital, Adelaide, South Australia, Australia
• The Queen Elizabeth Hospital, Woodville, South Australia, Australia
• Northern Hospital Epping, Epping, Victoria, Australia
• Austin Health, Heidelberg, Victoria, Australia
• The Alfred Hospital, Melbourne, Victoria, Australia
• Royal Melbourne Hospital, Melbourne, Victoria, Australia

+ 57 more sites.

Who to contact

Elena van Hest · 31205630316 · elena.vanhest@alimentiv.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06257706.