Study Evaluating Treatment Targets Including Transmural Healing in Adults With Moderate to Severe Crohns Disease Using Vedolizumab

What this Trial Is About

Researchers are investigating treatment strategies for adults with moderately to severely active Crohns disease CD. The study focuses on transmural healing TMH, a promising but not yet formal treatment target, assessed using noninvasive intestinal ultrasound IUS. The aim is to determine if treating patients to achieve corticosteroid-free IUS outcomes combined with clinical symptoms and biomarkers improves corticosteroid-free endoscopic remission better than targeting symptoms and biomarkers alone. Participants will be randomly assigned to one of two treatment groups for 48 weeks. Group 1 aims for corticosteroid-free remission based on IUS outcomes, clinical symptoms, and biomarkers, with specific IUS response assessments at weeks 22 and 30 and a final TMH target at week 38. Group 2 aims for corticosteroid-free clinical and biomarker remission without IUS targets. All participants receive vedolizumab infusions starting with an induction regimen followed by maintenance infusions every 8 weeks, with treatment adjustments at weeks 22, 30, and 38 based on target assessments. Throughout the study, participants will undergo regular assessments including IUS imaging, symptom evaluations, biomarker testing, and endoscopic scoring up to week 48 and beyond. Key measures include corticosteroid-free endoscopic remission, TMH rates, clinical remission, and biomarker responses. Safety and adverse events will be monitored, with follow-up visits extending to week 96. Participation involves adherence to study visits and treatment schedules to evaluate the impact of different treatment targets on disease activity.

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