A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease

Eligibility Criteria

• 1. Has a confirmed diagnosis of CD at least 3 months before baseline, based on endoscopy results.
• 2. Has moderately to severely active CD at Screening, defined as a CDAI score ≥220 and a SES-CD ≥6 (≥4 if isolated ileal disease).
• 3. Has demonstrated at least 1 of the following (a, b, or c) to at least 1 IL antagonist or at least 1 tumor necrosis factor (TNF) antagonist, at doses approved for the treatment of CD:
• 1. Inadequate response after completing the full induction regimen;
• 2. Loss of response (recurrence of symptoms during scheduled maintenance dosing after prior clinical benefit); or
• 3. Intolerance (a significant adverse event that precluded further use, including but not limited to serious infection including opportunistic infections, malignancy, infusion-related and hypersensitivity reactions including anaphylaxis, and liver injury).
• 4. Participant is in clinical remission at Week 26. Note: Participants exhibiting a clinical response (defined as a ≥ 100-point decrease in CDAI) at Week 26 may enter Part B at the investigator's discretion.
• 1. A current diagnosis of ulcerative colitis or indeterminate colitis.
• 2. Clinical evidence of a current abdominal abscess or a history of prior abdominal abscess.
• 3. Known fistula (other than perianal fistula) or phlegmon.
• 4. Known perianal fistula with abscess.
• 5. Ileostomy, colostomy, or severe, or symptomatic stenosis of the intestine.
• 6. Previous extensive colon resection with ≥2 colonic segments remaining, performed ≥ 6 months prior to screening.
• 7. Short bowel syndrome.
• 8. Any planned surgical intervention for CD, except for seton placement for perianal fistula without abscess.
• 9. History or evidence of adenomatous colonic polyps that have not been removed.
• 10. History or evidence of colonic mucosal dysplasia.
• 11. Intolerance or contraindication to ileocolonoscopy.
• 12. Any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection).
• 13. Active or latent tuberculosis (TB), regardless of treatment history.
• 14. A positive test for hepatitis B virus (HBV) as defined by the presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) test.
• 15. A positive test for hepatitis C virus (HCV), as defined by a positive hepatitis C virus antibody (HCVAb) test and detectable HCV ribonucleic acid (RNA).
• 16. Primary nonresponse to ≥2 IL antagonists (Cohort 1) or ≥2 TNF antagonists (Cohort 2) for the treatment of CD.
• 17. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \[AMG 181\], anti- mucosal addressin cell adhesion molecule-1 \[MAdCAM-1\] antibodies, or rituximab).
• 18. History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion. If a participant has symptoms consistent with PML, a PML checklist must be completed and submitted to the PML independent adjudication committee (IAC). If the PML IAC deems the participant to have PML, the participant is ineligible.