A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)

Eligibility Criteria

• 1. Has a confirmed diagnosis of UC established at least 3 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report.
• 2. Has moderately to severely active UC as determined by a complete Mayo score \[including physician's global assessment (PGA)\] of 6 to 12 with a rectal bleeding subscore ≥\>1 and a centrally assessed endoscopic subscore ≥2 at screening.
• 3. Has evidence of UC extending proximally to the rectum \[≥15 centimeter (cm) of involved colon\].
• 4. Participants with extensive colitis or pancolitis of \>8 years duration or left sided colitis \>12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit.
• 5. Participants with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>50 years, or other known risk factors must be up to date on colorectal cancer surveillance.
• 6. Has demonstrated an inadequate response to, loss of response to, or intolerance to no more than 2 TNF antagonists.
• 7. If using corticosteroids must be on a stable dose of oral corticosteroids up to a maximum of 20 milligrams per day (mg/day) of prednisone or equivalent for at least 4 weeks prior to screening endoscopy and must be willing to follow a mandatory taper of corticosteroids from enrollment.