A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis

Exclusion Criteria

• •1. Has Crohn's disease (CD), or CD of the pouch.
• •2. Has irritable pouch syndrome (IPS).
• •3. Has isolated or predominant cuffitis.
• •4. Has mechanical complications of the pouch (e.g., pouch stricture or pouch fistula).
• •5. Currently requires or has a planned surgical intervention for UC during the study.
• •6. Has diverting stoma.
• •2\. Has active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following:
• •1. A diagnostic TB test performed within 30 days of Screening or during the Screening Period that is positive, as defined by:
• •1. A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests. OR
• •2. A tuberculin skin test reaction ≥10 mm (≥5 mm in participants receiving the equivalent of \>15 mg/day prednisone).
• •OR
• •2. Chest X-ray within 3 months prior to Day 1 that is suspicious for pulmonary TB, and a positive or 2 successive indeterminate QuantiFERON test within 30 days prior to Screening or during the Screening Period.
• •3\. Has chronic hepatitis B virus (HBV) infection\* or chronic hepatitis C virus (HCV) infection\*\* or a known history of human immunodeficiency virus (HIV) infection (or is found to be seropositive at Screening) or participant is immunodeficient (e.g., due to organ transplantation, history of common variable immunodeficiency, etc).
• •\* Participants who are positive for hepatitis B virus surface antigen (HBsAg) will be excluded. For participants who are negative for HBsAg but are positive for either surface antibodies and/or core antibodies, HBV Deoxyribonucleic acid (DNA) polymerase chain reaction will be performed and if any test result meets or exceeds detection sensitivity, the participant will be excluded.
• •* If participant is HCV antibody positive, then a viral load test will be performed. If the viral load test is positive then the participant will be excluded.
• •4\. Has evidence of active infection with Clostridium (C) difficile during Screening (to be confirmed by laboratory test)
• •1. Has any prior exposure to vedolizumab, natalizumab, efalizumab, rituximab, etrolizumab, or anti-mucosal addressin cell adhesion molecule-1 (MAdCAM-1) therapy.
• •2. Has a history of hypersensitivity or allergies to vedolizumab or its components.
• •3. Has allergies to and/or contraindications for ciprofloxacin, a history of tendon disorders related to quinolone administration and/or glucose-6-phosphate dehydrogenase (G6PD) deficiency. Further conditions requiring precautions for use of ciprofloxacin have to be considered based on local prescribing information.
• •4. Is taking, has taken, or is required to take any excluded medications.
• •5. Has received any investigational or approved biologic or biosimilar agent within 60 days prior to Randomization.
• •6. Has received an investigational nonbiologic therapy within 30 days prior to Randomization.
• •7. Has received an approved nonbiologic therapy (including 5-aminosalicylate \[5-ASA\], corticosteroid, azathioprine, 6-mercaptopurine \[6-MP\], etc.) in an investigational protocol within 30 days prior to Randomization.
• •8. Has received any live vaccinations within 30 days prior to randomization.
• •9. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist at Screening.
• •10. Has had a kidney, heart, or lung transplant.
• •11. Has a history of malignancy, except for the following: adequately-treated non-metastatic basal cell skin cancer; squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to the Screening visit; and history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to Screening. Participants with a 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 enrollment.
• •12. Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease.
• •13. Has conditions, which in the opinion of the investigator, may interfere with the participant's ability to comply with the study procedures.
• •14. Has any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal (GI), genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurologic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety.
• •15. Has any of the following laboratory abnormalities during the Screening Period:
• •<!-- -->
• •1. Hemoglobin level \<8 g/dL.
• •2. White blood cell (WBC) count \<3 × 10\^9/L.
• •3. Lymphocyte count \<0.5 × 10\^9/L.
• •4. Platelet count \<100 × 10\^9/L or \>1200 × 10\^9/L.
• •5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × the upper limit of normal (ULN).
• •6. Alkaline phosphatase \>3 × ULN.
• •7. Serum creatinine \>2 × ULN.
• •16\. If female, the participant is pregnant or lactating or intending to become pregnant or nurse before, during, or within 18 weeks after the last dose of study medication; or intending to donate ova during such time period.
• •17\. If male, the participant intends to donate sperm or father a child during the course of this study or for 18 weeks after the last dose of study medication.
• •18\. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
• •19\. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to Screening.