An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Vedolizumab; Adalimumab placebo; Adalimumab; Vedolizumab placebo
Intervention description: Vedolizumab infusion; Adalimumab placebo-matching injection; Adalimumab injection; Vedolizumab placebo-matching infusion
Intervention MeSH terms: Adalimumab; Vedolizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 771.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous
      (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment
      period.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has a diagnosis of ulcerative colitis established at least 3 months prior to screening
             by clinical and endoscopic evidence and corroborated by a histopathology report.

          2. Has moderately to severely active ulcerative colitis as determined by a Mayo score of
             6 to 12 with an endoscopic subscore greater than or equal to >=2 within 14 days prior
             to the randomization.

          3. Has evidence of ulcerative colitis proximal to the rectum (>=15 centimeter [cm] of
             involved colon).

          4. With extensive colitis (up to the hepatic flexure) or pancolitis of >8 years duration
             or left-sided colitis of >12 years duration must have documented evidence that a
             surveillance colonoscopy was performed within 12 months of the initial screening visit
             (may be performed during the Screening Period).

          5. The participant:

               1. Has had previous treatment with tumor necrosis factor- alpha (TNF-alpha)
                  antagonists without documented clinical response to treatment (example, due to
                  lack of response [primary nonresponders], loss of response, or intolerance
                  [secondary nonresponders]), or

               2. Has previously used a TNF-alpha antagonists (except adalimumab), and discontinued
                  its use due to reasons other than safety, or

               3. Is naïve to TNF-alpha antagonist therapy but is failing current treatment
                  (example, corticosteroids, 5-aminosalicylate [5-ASA], or immunomodulators).

        Exclusion Criteria:

          1. Clinical evidence of abdominal abscess or toxic megacolon at Screening.

          2. Has had an extensive colonic resection, subtotal or total colectomy.

          3. Has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.

          4. Has a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis,
             radiation colitis, diverticular disease associated with colitis, or microscopic
             colitis.

          5. Has received any of the following for the treatment of underlying disease within 30
             days of randomization:

               1. Non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide) other
                  than those specifically listed in Section Permitted Medications For Treatment of
                  UC.

               2. An approved non-biologic therapy in an investigational protocol.

          6. Has received any investigational or approved biologic or biosimilar agent within 60
             days or 5 half lives prior to the screening (whichever is longer).

          7. Has previously received natalizumab, efalizumab, adalimumab, AMG-181, anti-mucosal
             addressin cell adhesion molecule-1 antibodies, or rituximab.

          8. Has previously received vedolizumab.

          9. Has history or evidence of adenomatous colonic polyps that have not been removed, or
             colonic mucosal dysplasia.

         10. Evidence of an active infection during Screening.

         11. Evidence of, or treatment for, Clostridium difficile (C. difficile) or other
             intestinal pathogen within 28 days prior to the 1st dose of study drug.

         12. Has chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus (HCV)
             infection (* HBV immune participants, ie, being hepatitis B surface antigen [HBsAg],
             may participate).

         13. Has active or latent TB, regardless of treatment history.

         14. Has used a topical (rectal) treatment with (5-ASA) or corticosteroid
             enemas/suppositories within 2 weeks of the administration of the 1st dose of study
             drug.

         15. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom
             checklist prior to the administration of the first dose of study drug.