VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease
Recruiting
Phase 4
Interventional Study
Moderately to Severely Active Crohn's Disease
Crohn Disease
Disease Crohn
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 304 (estimated)
- Sponsor
- Alimentiv Inc. · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Adults aged 18 to 80 years, inclusive, at the time of consent;
2. 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);
3…
Contacts