A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Etrolizumab; Infliximab; Placebo (IV); Placebo (Injection)
Intervention description: 105 mg administered by subcutaneous (SC) injection once every 4 weeks (Q4W) until Week 52.; 5 mg/kg of infliximab will be administered by intravenous (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.; Administered by (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.; Administered by SC injection Q4W until Week 52
Intervention MeSH terms: Infliximab; Etrolizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 397.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group
      study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with
      infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are
      naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1
      ratio to receive either etrolizumab 105 milligrams (mg) by subcutaneous (SC) injection once
      every 4 weeks (Q4W) + placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then once
      every 8 weeks [Q8W]) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6,
      then Q8W) + placebo (SC Q4W). Time on treatment is 54 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderately to severely active UC as determined by the Mayo Clinic Score assessment
             (MCS)

          -  Naive to treatment with any anti-TNF inhibitor therapy (including TNF inhibitor
             biosimilars)

          -  An inadequate response to or intolerance of prior corticosteroid and/or
             immunosuppressant treatment

          -  Background regimen for UC may include oral 5-aminosalicylate (5-ASA), oral
             corticosteroids, budenoside multi-matrix system (MMX), probiotics, azathioprine (AZA),
             6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the
             screening period

          -  Use of highly effective contraception during and at least 24 weeks after the last dose
             of study drug

        Exclusion Criteria:

          -  A history of or current conditions and diseases affecting the digestive tract, such as
             indeterminate colitis, suspicion of ischemic, radiation or microscopic colitis,
             Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia,
             intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps

          -  Prior or planned surgery for UC

          -  Past or present ileostomy or colostomy

          -  Have received non-permitted inflammatory bowel disease (IBD) therapies (including
             natalizumab, vedolizumab, efalizumab, and tofactinib)

          -  History of moderate or severe allergic or anaphylactic/anaphylactoid reactions to
             chimeric, human, or humanized antibodies; fusion proteins, or murine proteins;
             hypersensitivity to etrolizumab or any of its excipients

          -  Chronic hepatitis B or C infection, Human deficiency virus (HIV) or tuberculosis
             (active or latent)