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.
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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

Elena van Hest

31205630316

elena.vanhest@alimentiv.com

CONTACT