Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease.
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Vedolizumab IV; Placebo
Intervention description: Vedolizumab IV infusion; Vedolizumab placebo-matching
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: 215.0
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 safety and efficacy of vedolizumab intravenous
      (IV) infusion as induction treatment in Chinese participants with moderately to severely
      active Crohn's disease (CD) at Week 10.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has a diagnosis of Crohn's disease (CD) established at least 3 months prior to
             Screening by clinical and endoscopic evidence corroborated by a histopathology report.
             Cases of CD established at least 6 months prior to randomization for which a
             histopathology report is not available will be considered based on the weight of
             evidence supporting the diagnosis and excluding other potential diagnosis, and must be
             discussed with the sponsor on a case-by-case basis prior to randomization.

          2. Has moderately to severely active CD as determined by a Crohn's Disease Activity Index
             (CDAI) score of 220 to 400 within 7 days prior to the first dose of study drug and 1
             of the following:

               -  C-reactive protein (CRP) level >2.87 mg/L during the Screening Phase, OR

               -  Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic
                  ulcerations (each >0.5 cm in diameter) or 10 aphtous ulcerations (involving a
                  minimum of 10 contiguous cm of intestine) consistent with CD, within 4 months
                  prior to randomization, OR

               -  Fecal calprotectin >250 μg/g stool during the Screening Phase 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), within 4 months prior to
                  Screening

          3. Has CD involvement of the ileum and/or colon, at a minimum.

          4. Has extensive colitis or pancolitis of >8 years duration or limited colitis of >12
             years duration must have documented evidence that a surveillance colonoscopy was
             performed within 12 months prior to initial screening (may be performed during
             Screening if not performed in previous 12 months).

          5. Has a family history of colorectal cancer, personal history of increased colorectal
             cancer risk, age >50 years, or other known risk factor must be up-to-date on
             colorectal cancer surveillance (may be performed during Screening).

          6. Has demonstrated an inadequate response to, loss of response to, or intolerance of at
             least 1 of the following agents as defined below:

               -  Corticosteroids.

               -  Immunomodulators.

               -  Tumor necrosis factor-alpha (TNF-α) antagonists.

        Exclusion Criteria:

          1. Has evidence of abdominal abscess at the initial Screening Visit.

          2. Has had extensive colonic resection, subtotal or total colectomy.

          3. Has a history of >3 small bowel resections or diagnosis of short bowel syndrome.

          4. Has had ileostomy, colostomy, known fixed symptomatic stenosis of the intestine, or
             evidence of fixed stenosis, or small bowel stenosis with prestenotic dilation.

          5. Has had previous exposure to approved or investigational anti-integrins (e.g.,
             natalizumab, efalizumab, etrolizumab, or AMG-181), or MAdCAM-1 antagonists, or
             rituximab.

          6. Has used topical (rectal) treatment with 5-ASA, corticosteroid enemas/suppositories or
             traditional Chinese medications for CD treatment within 2 weeks of the administration
             of the first dose of study drug.

          7. Requires currently or is anticipated to require surgical intervention for CD during
             the study.

          8. Has a history or evidence of adenomatous colonic polyps that have not been removed.

          9. Has a history or evidence of colonic mucosal dysplasia including low or high-grade
             dysplasia, as well as indeterminate for dysplasia.

         10. Has a suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis,
             ischemic colitis, and radiation colitis.

         11. Has evidence of treatment for C.difficile infection or other intestinal pathogen with
             28 days prior to first dose of study drug.

         12. Has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV)
             infection.

         13. Has active or latent tuberculosis.

         14. Has any identified congenital or acquired immunodeficiency (e.g., common variable
             immunodeficiency, human immunodeficiency virus [HIV] infection, organ
             transplantation).

         15. Has any history of malignancy, except for the following: (a) adequately-treated
             nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been
             adequately treated and that has not recurred for at least 1 year prior to
             randomization; and (c) history of cervical carcinoma in situ that has been adequately
             treated and that has not recurred for at least 3 years prior to randomization.
             Participants with remote history of malignancy (e.g., >10 years since completion of
             curative therapy without recurrence) will be considered based on the nature of the
             malignancy and the therapy received and must be discussed with the sponsor on a
             case-by-case basis prior to randomization.

         16. Has a history of any major neurological disorders, including stroke, multiple
             sclerosis, brain tumor, or neurodegenerative disease.

         17. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom
             checklist at Screening or prior to the administration of the first dose of study drug
             at Week 0.