Vedolizumab Subcutaneous (SC) Versus Intravenous (IV) in Ulcerative Colitis or Crohn's Disease

Inclusion Criteria

• •1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• •2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedure.
• •3. Is aged 18 to 80 years, inclusive.
• •4. The male or female participant is voluntarily able to give informed consent.
• •5. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
• •6. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
• •7. Has a diagnosis of ulcerative colitis (UC) established at least 3 months prior to randomization by clinical and endoscopic evidence and corroborated by a histopathology report.
• •8. Has moderately to severely active UC as determined by a partial Mayo score of 3 to 9 within 7 days prior to the first dose of study drug.
• •9. Has evidence of UC extending proximal to the rectum (≥15 cm of involved colon).
• •10. Participants with extensive colitis or pancolitis of \>8 years duration or left-sided colitis of \>12 years duration must have documented evidence that a surveillance colonoscopy with random and targeted biopsies was performed within 18 months of the initial screening visit (may be performed during screening).
• •11. Participants with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>50 years, or other known risk factor for colorectal cancer must be up-to-date on colorectal cancer surveillance (may be performed during screening).
• •12. Participants may be receiving a therapeutic dose of the following drugs:
• •1. Oral or topical (rectal) 5-aminosalicylate (5-ASA) compounds provided that the dose has been stable for the 2 weeks immediately prior to randomization;
• •2. Oral corticosteroid therapy (prednisone at a stable dose ≤30 mg/day, budesonide at a dose ≤9 mg/day or equivalent steroid) provided that the dose has been stable for the 4 weeks immediately prior to randomization if corticosteroids have just been initiated, or for the 2 weeks immediately prior to randomization if corticosteroids are being tapered;
• •3. Topical (rectal) corticosteroid enemas/suppositories;
• •4. Azathioprine or 6-mercaptopurin provided that the dose has been stable for the 8 weeks immediately prior to randomization;
• •5. Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea;
• •6. Probiotics (eg, Culturelle, S. boulardii) provided that the dose has been stable for the 2 weeks immediately prior to randomization;
• •7. Antibiotics used for the treatment of inflammatory bowel disease (IBD) (ie, ciprofloxacin, metronidazole).
• •13. Has a diagnosis of Crohn's Disease (CD) established at least 3 months prior to randomization by clinical and endoscopic evidence and corroborated by a histopathology report. Cases of CD established at least 3 months prior to randomization for which a histopathology report is not available will be considered based on the weight of the evidence supporting the diagnosis and excluding other potential diagnoses, and must be discussed with the sponsor on a case-by-case basis prior to randomization.
• •14. Has moderately to severely active CD as determined by Crohn's Disease Activity Index (CDAI) score of 220 to 450 within 7 days prior to the first dose of study drug and 1 of the following:
• •1. C-reactive protein (CRP) level \>2.87 mg/L during the Screening Period, OR;
• •2. Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic ulcerations (each \>0.5 cm in diameter) or 10 aphthous ulcerations (involving a minimum of 10 contiguous cm of intestine) consistent with CD, within 4 months prior to randomization, OR;
• •3. Fecal calprotectin \>250 mcg/g stool during the Screening Period in conjunction with Computed Tomography (CT) enterography, magnetic resonance (MR) enterography, contrast-enhanced small bowel radiography, or wireless capsule endoscopy revealing Crohn's ulcerations (aphthae not sufficient), within 4 months prior to screening (participants with evidence of fixed stenosis or small bowel stenosis with prestenotic dilation should not be included).
• •15. Has CD involvement of the ileum and/or colon, at a minimum.
• •16. Participants with extensive colitis or pancolitis of \>8 years duration or limited colitis of \>12 years duration must have documented evidence that a surveillance colonoscopy with random and targeted biopsies was performed within 18 months of randomization (may be performed during screening).
• •17. Participants with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>50 years, or other known risk factor for colorectal cancer must be up-to-date on colorectal cancer surveillance (may be performed during screening).
• •18. Participants may be receiving a therapeutic dose of the following drugs:
• •1. Oral or topical (rectal) 5-ASA compounds provided that the dose has been stable for the 2 weeks immediately prior to randomization;
• •2. Oral corticosteroid therapy (prednisone at a stable dose ≤30 mg/day, budesonide at a dose ≤9 mg/day, or equivalent steroid) provided that the dose has been stable for the 4 weeks immediately prior to randomization if corticosteroids have just been initiated, or for the 2 weeks immediately prior to randomization if corticosteroids are being tapered;
• •3. Topical (rectal) corticosteroid enemas/suppositories;
• •4. Antibiotics used for the treatment of IBD (ie, ciprofloxacin, metronidazole);
• •5. Azathioprine or 6-mercaptopurin provided that the dose has been stable for the 8 weeks immediately prior to randomization;
• •6. Methotrexate provided that the dose has been stable for the 8 weeks immediately prior to randomization;
• •7. Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea;
• •8. Probiotics (eg, Culturelle, S. boulardii) provided that the dose has been stable for the 2 weeks immediately prior to randomization.