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

Korábbi kezelés

• Previous extensive bowel resection with 2 entire segments missing, of the following: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
• 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) for the treatment of CD.

Más betegség

• Known fistula (other than perianal fistula) or phlegmon.
• Known perianal fistula with abscess.
• Short bowel syndrome.
• Any planned surgical intervention for CD, except for seton placement for perianal fistula without abscess.
• Any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency infection).
• Active or latent tuberculosis (TB), regardless of treatment history.
• 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.
• 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).
• 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. If the PML IAC deems the participant to have PML, the participant is ineligible.

Egyéb

• CDAI score > 450.
• A current diagnosis of ulcerative colitis or indeterminate colitis.
• Clinical evidence of an abdominal abscess.
• Ileostomy, colostomy, or severe, or symptomatic stenosis of the intestine.
• History or evidence of adenomatous colonic polyps that have not been removed.
• History or evidence of colonic mucosal dysplasia.
• Intolerance or contraindication to ileocolonoscopy.

• Part A:
• Has a confirmed diagnosis of CD at least 3 months before screening, based on endoscopy results.
• Has moderately to severely active CD at Screening, defined as an SES-CD >=6 (>=4 if isolated ileal disease).
• 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:
  • Inadequate response after completing the full induction regimen;
  • Loss of response (recurrence of symptoms during scheduled maintenance dosing after prior clinical benefit); or
  • 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).
  • Note: Participants with an inadequate response to >2 classes of advanced therapies or >1 agent in the same class are not eligible. Participants who discontinued a third class of advanced therapy for reasons other than inadequate response may be eligible after discussion with the Medical Monitor.
  • Part B:
• In the investigator's opinion, the participant exhibits a therapeutic benefit at Week 26.