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

Exclusion Criteria

• •1. Current or previous treatment with vedolizumab, etrolizumab, or natalizumab;
• •2. 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;
• •3. 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;
• •4. Only have inflammation proximal to the terminal ileum that cannot be reached by ileocolonoscopy;
• •5. Have a CD complication, such as symptomatic strictures in the small bowel with \>3 cm prestenotic dilatation on any imaging modality, requiring procedural intervention;
• •6. Previous extensive colonic resection or missing \>2 segments out of 5 (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum), ileorectal anastomosis, or a proctocolectomy;
• •7. Ostomy or ileoanal pouch;
• •8. Short bowel syndrome;
• •9. Fibrotic-only stricture in the ileum or colon without evidence of active inflammation (in the investigator's judgment), including any impassable stenosis;
• •10. Abscess \>2 cm, detected by IUS or endoscopy; participants with draining fistulas are not excluded;
• •11. Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the participant's ability to participate fully in the study or would compromise participant safety;
• •12. Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin);
• •13. Known HIV or hepatitis B or C infection. If a negative test result is available in the 12 months prior to randomization, retesting is not required;
• •14. Known active or latent tuberculosis (TB); if a negative test result is available in the 12 months prior to randomization, confirmatory testing (per standard of care) is not required before randomization;
• •15. Other systemic or opportunistic infection (including cytomegalovirus), any other clinically significant extraintestinal infection, or recurring infection within 6 months of randomization;
• •16. Has active cerebral/meningeal disease, signs, symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization;
• •17. Hypersensitivity, allergy, or intolerance to any excipient of vedolizumab or any other contraindication to vedolizumab;
• •18. Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection.
• •19. Unwillingness to withhold protocol-prohibited medications during the trial;
• •20. Concurrent or previous participation in another clinical trial and received any investigational therapy within 30 days prior to randomization;
• •21. History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures;
• •22. Prior enrolment in the current study and had received study treatment;
• •23. Pregnant, lactating, or intending to become pregnant/impregnate a partner before, during, or within 18 weeks after the last dose; or intending to donate ova or sperm during such time period;
• •24. Vaccination with a live or live-attenuated vaccine within 4 weeks prior to randomization, or planned vaccination with a live or live-attenuated vaccine during participation in the study;
• •25. Any person performing mandatory military service, deprived of liberty, in a residential care setting, or any person who, due to a judicial decision, cannot take part in clinical studies;
• •26. The person is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling).