Health Trials

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 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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Vedolizumab

Treatment groups

304 Participants
are divided into 2 treatment groups

Locations

69
Australia
Concord Repatriation General Hospital2139, ConcordNew South Wales, Australia
Mater Misericordiae Ltd4101, South BrisbaneQueensland, Australia
Calvary Adelaide Hospital5000, AdelaideSouth Australia, Australia
Royal Adelaide Hospital5000, AdelaideSouth Australia, Australia

Sponsors and collaborators

Alimentiv Inc.

Lead sponsor

Takeda

Collaborator

Source ClinicalTrials.gov