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

Inclusion Criteria:

Part A:

1. Has a confirmed diagnosis of CD at least 3 months before baseline, based onendoscopy results.

2. Has moderately to severely active CD at Screening, defined as a CDAI score ≥220 anda 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 ILantagonist or at least 1 tumor necrosis factor (TNF) antagonist, at doses approvedfor the treatment of CD:

4. Inadequate response after completing the full induction regimen;

5. Loss of response (recurrence of symptoms during scheduled maintenance dosingafter prior clinical benefit); or

6. Intolerance (a significant adverse event that precluded further use, includingbut not limited to serious infection including opportunistic infections,malignancy, infusion-related and hypersensitivity reactions includinganaphylaxis, and liver injury). Note: Participants with primary nonresponse to ≥2 agents are not eligible.Participants with intolerance to 2 agents may be eligible at the investigator'sdiscretion. Part B:

7. Participant is in clinical remission at Week 26. Note: Participants exhibiting aclinical response (defined as a ≥ 100-point decrease in CDAI) at Week 26 may enterPart B at the investigator's discretion.

Exclusion Criteria:

1. A current diagnosis of ulcerative colitis or indeterminate colitis.

2. Clinical evidence of a current abdominal abscess or a history of prior abdominalabscess.

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 ≥ 6months prior to screening.

7. Short bowel syndrome.

8. Any planned surgical intervention for CD, except for seton placement for perianalfistula 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 variableimmunodeficiency, 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 hepatitisB 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 Cvirus 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 addressincell adhesion molecule-1 [MAdCAM-1] antibodies, or rituximab).

18. History of or symptoms of progressive multifocal leukoencephalopathy (PML) in theinvestigator's opinion. If a participant has symptoms consistent with PML, a PMLchecklist must be completed and submitted to the PML independent adjudicationcommittee (IAC). If the PML IAC deems the participant to have PML, the participantis ineligible.