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VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease
NCT06257706 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- BIOLOGICAL Vedolizumab
Study Locations (20)
Victoria
- Northern Hospital Epping — Epping
- Austin Health — Heidelberg
- The Alfred Hospital — Melbourne
- Royal Melbourne Hospital — Melbourne
South Australia
- Calvary Adelaide Hospital — Adelaide
- Royal Adelaide Hospital — Adelaide
- The Queen Elizabeth Hospital — Woodville
California
- TLC Clinical Research Inc - Los Angeles — Los Angeles
South Carolina
- Medical University of South Carolina (MUSC) — Charleston
Texas
- Houston Methodist Hospital — Houston
New South Wales
- Concord Repatriation General Hospital — Concord
Queensland
- Mater Misericordiae Ltd — South Brisbane
Western Australia
- Harry Perkins institute of Medical Research - Fiona Stanley Hospital — Murdoch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2024-08-07 |
| Est. Completion | 2029-02-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06257706
The ClinicalTrials.gov registry entry for NCT06257706 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alimentiv, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Crohn Disease appearing as the primary indexed condition, and to 1 intervention — of which Vedolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06257706 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Victoria, South Australia, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06257706 about?
NCT06257706 is a clinical study titled "VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease". 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 pa...
What is the current status of trial NCT06257706?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 304 participants. The study started on 2024-08-07. Estimated completion is 2029-02-06.
What conditions does trial NCT06257706 study?
This clinical trial studies the following conditions: Crohn Disease, Moderately to Severely Active Crohn's Disease, Disease Crohn. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06257706?
The interventions under investigation include: Vedolizumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06257706?
This trial is sponsored by Alimentiv, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06257706 being conducted?
This trial has 20 study locations across California, South Carolina, Texas, New South Wales, Queensland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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