A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Condition: Colitis, Ulcerative; Inflammatory Bowel Diseases
MeSH terms: Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer
Intervention: Placebo IV; Placebo SC; Ustekinumab IV; Ustekinumab SC
Intervention description: Placebo will be administered as intravenous infusion.; Placebo will be administered Subcutaneously.; Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.; Ustekinumab will be administered as subcutaneously.
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 961.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ustekinumab; Inflammatory Bowel Diseases (IBD); Colitis, Ulcerative

Summary:

      The purpose of this study is to evaluate the efficacy and safety of ustekinumab as
      intravenous (IV: into the vein) infusion in induction study in participants with moderately
      to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in
      maintenance study in participants with moderately to severely active Ulcerative Colitis (UC)
      who have demonstrated a clinical response to Induction treatment with IV ustekinumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a clinical diagnosis of Ulcerative Colitis (UC) at least 3 months before Screening

          -  Has moderately to severely active UC, defined as a Baseline (Week 0) Mayo score of 6
             to 12, including a Screening endoscopy subscore of the Mayo score greater than or
             equal to (>=) 2 as determined by a central reading of the video endoscopy

          -  Have failed biologic therapy, that is, have received treatment with 1 or more tumour
             necrosis factor (TNF) antagonists or vedolizumab at a dose approved for the treatment
             of UC, and have a documented history of failure to respond to or tolerate such
             treatment; OR Be naïve to biologic therapy (TNF antagonists or vedolizumab) or have
             received biologic therapy but have not demonstrated a history of failure to respond
             to, or tolerate, a biologic therapy and have a prior or current UC medication history
             that includes at least 1 of the following: a. Inadequate response to or failure to
             tolerate current treatment with oral corticosteroids or immunomodulators
             (6-mercaptopurine [6-MP] or azathioprine [AZA]) OR b. History of failure to respond
             to, or tolerate, at least 1 of the following therapies: oral or IV corticosteroids or
             immunomodulators (6-MP or AZA) OR c. History of corticosteroid dependence (that is, an
             inability to successfully taper corticosteroids without a return of the symptoms of
             UC)

          -  Before the first administration of study agent, the following conditions must be met:
             vedolizumab must have been discontinued for at least 4 months and anti-tumor necrosis
             factors (TNFs) for at least 8 weeks

        Exclusion Criteria:

          -  Has severe extensive colitis and is at imminent risk of colectomy

          -  Has UC limited to the rectum only or to < 20 centimeters (cm) of the colon

          -  Presence of a stoma or history of a fistula

          -  Participants with history of extensive colonic resection (for example, less than 30 cm
             of colon remaining) that would prevent adequate evaluation of the effect of study
             agent on clinical disease activity

          -  Participants with history of colonic mucosal dysplasia. Participants will not be
             excluded from the study because of a pathology finding of "indefinite dysplasia with
             reactive atypia''