A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: UTTR1147A; UTTR1147A Placebo; Vedolizumab; Vedolizumab Placebo
Intervention description: UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.; The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.; Vedolizumab will be administered IV, as specified in the prescribing information.; The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.
Intervention MeSH terms: Vedolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 195.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A
      compared with vedolizumab and with placebo in the treatment of participants with moderate to
      severe UC. This study will consist of two parts, Part A and Part B. Part A will test the
      induction of clinical remission and Part B will test the durability of clinical remission.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of UC

          -  Confirmation of moderately to severely active UC, defined by the Mayo Clinic Score

          -  Inadequate response, loss of response, or intolerance to prior immunosuppressant
             treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis
             factor [TNF] inhibitors [maximum of 2 prior TNF inhibitors]) and/or corticosteroid
             treatment

          -  Use of highly effective contraception as defined by the protocol

        Exclusion Criteria:

          -  History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders
             requiring oral corticosteroids, immunosuppressants, or biological therapy within the
             previous year; or primary sclerosing cholangitis

          -  History of cancer as defined by the protocol

          -  Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic,
             endocrine, or gastrointestinal disorders (excluding UC)

          -  Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or
             planned surgery for UC

          -  Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis or toxic
             megacolon within 12 months prior to screening

          -  Suspicion of ischemic colitis, radiation colitis, or microscopic colitis

          -  Current fistula or history of fistula, pericolonic abscess and stricture (stenosis) of
             the colon

          -  History or current evidence of unresectable colonic mucosal dysplasia or history of
             high-grade colonic mucosal dysplasia

          -  Prior treatment with UTTR1147A

          -  Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other
             anti-integrin agents

          -  Prior treatment with rituximab

          -  Use of prohibited therapies, as defined by the protocol, prior to randomization

          -  Congenital or acquired immune deficiency

          -  Evidence or treatment of infections or history of infections, as defined by the
             protocol