Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Vedolizumab 300 mg IV; Placebo IV; Vedolizumab 108 mg SC; Placebo SC
Intervention description: Vedolizumab intravenous infusion; Vedolizumab intravenous infusion placebo; Vedolizumab subcutaneous injection; Vedolizumab subcutaneous injection placebo
Intervention MeSH terms: Vedolizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 383.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab
      SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to
      severely active ulcerative colitis (UC) who achieved clinical response following
      administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of ulcerative colitis (UC) established at least 6 months prior to screening,
             by clinical and endoscopic evidence and corroborated by a histopathology report.

          2. Moderately to severely active UC as determined by a complete Mayo score of 6-12 (with
             an endoscopic subscore ≥2)

          3. Evidence of UC extending proximal to the rectum (≥15 cm of involved colon).

          4. Inadequate response with, loss of response to, or intolerance to corticosteroids,
             immunomodulators, or Tumor Necrosis Factor-alpha (TNF-α) antagonists

        Exclusion Criteria:

          1. Evidence of abdominal abscess or toxic megacolon at the initial Screening Visit.

          2. Extensive colonic resection, subtotal or total colectomy.

          3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.

          4. Prior exposure to investigational or approved non-biologic therapies (eg,
             cyclosporine, tacrolimus, thalidomide, methotrexate or tofacitinib) for the treatment
             of underlying disease within 30 days or 5 half-lives of screening (whichever is
             longer).

          5. Prior exposure to any investigational or approved biologic or biosimilar agent within
             60 days or 5 half-lives of screening (whichever is longer).

          6. Prior exposure to vedolizumab

          7. Surgical intervention for UC required at any time during the study.

          8. History or evidence of adenomatous colonic polyps that have not been removed or has a
             history or evidence of colonic mucosal dysplasia.

          9. Suspected or confirmed diagnosis of Crohn's entercolitis, indeterminate colitis,
             ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or
             microscopic colitis.

         10. Active infections

         11. Chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV)
             infection, HIV or tuberculosis (active or latent), identified congenital or acquired
             immunodeficiency. HBV immune participants (ie, being hepatitis B surface antigen
             [HBsAg] negative and hepatitis B antibody positive) may, however, be included.

         12. History of any major neurological disorders, including stroke, multiple sclerosis,
             brain tumor, demyelinating or neurodegenerative disease.