Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Vedolizumab SC 108 mg; Placebo; Vedolizumab IV 300 mg
Intervention description: Vedolizumab SC Injection.; Vedolizumab placebo-matching SC injection.; Vedolizumab IV Injection.
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: 644.0
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) as maintenance treatment in participants with moderately to severely active CD who
      achieved clinical response following administration of vedolizumab intravenous (vedolizumab
      IV) induction therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of CD established at least 3 months prior to screening by clinical and
             endoscopic evidence corroborated by a histopathology report.

          2. Moderately to severely active CD as determined by a CDAI score of 220 to 450 and 1 of
             the following:

               -  C-reactive protein (CRP) level greater than (>) 2.87 milligram per liter (mg/L)
                  OR

               -  Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic
                  ulcerations (each >0.5 centimeter [cm] in diameter) or 10 aphthous ulcerations
                  (involving a minimum of 10 contiguous cm of intestine) consistent with CD OR

               -  Fecal calprotectin >250 microgram per gram (mcg/g) stool during the screening
                  period in conjunction with computed tomography enterography (CTE), magnetic
                  resonance enterography (MRE), contrast-enhanced small bowel radiography, or
                  wireless capsule endoscopy revealing CD ulcerations (aphthae not sufficient).

          3. CD involvement of the ileum and/or colon, at a minimum.

          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 at Screening.

          2. Extensive colonic resection, subtotal or total colectomy.

          3. History of >3 small bowel resections or diagnosis of short bowel syndrome.

          4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.

          5. Prior exposure to investigational or approved non-biologic therapies (example,
             cyclosporine, tacrolimus, thalidomide, or tofacitinib) for the treatment of underlying
             disease within 30 days or 5 half-lives of screening (whichever is longer).

          6. Prior exposure to any investigational or approved biologic or biosimilar agent within
             60 days or 5 half-lives of screening (whichever is longer).

          7. Prior exposure to vedolizumab.

          8. Surgical intervention for CD required at any time during the study.

          9. History or evidence of adenomatous colonic polyps that have not been removed, or of
             colonic mucosal dysplasia.

         10. Suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis,
             ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or
             microscopic colitis.

         11. Active infections.

         12. Chronic hepatitis B virus (HBV) or C (HCV) infection, tuberculosis (TB) (active or
             latent), or congenital or acquired immunodeficiency. HBV immune participants (that is,
             being hepatitis B surface antigen [HBsAg] negative and hepatitis B antibody positive)
             may, however, be included.

         13. History of any major neurological disorders, including stroke, multiple sclerosis,
             brain tumor, or neurodegenerative disease.