Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study was to determine the effect of vedolizumab induction
      treatment on clinical response at 6 weeks and to determine the effect of vedolizumab
      maintenance treatment on clinical remission at 52 weeks.
    

Detailed description: 
      This multicenter, phase 3, randomized, blinded, placebo-controlled study in patients with
      moderately to severely active ulcerative colitis comprises two phases:

        -  The Induction Phase, designed to establish the efficacy and safety of vedolizumab for
           the induction of clinical response and remission.

        -  The Maintenance Phase, designed to establish the efficacy and safety of vedolizumab for
           the maintenance of clinical response and remission.

      The 6-week Induction Phase contained 2 cohorts of participants: Cohort 1 participants were
      randomized and treated with double-blind study drug, and Cohort 2 participants were treated
      with open-label vedolizumab. The second cohort was enrolled to ensure that the sample size of
      Induction Phase responders randomized into the Maintenance Study provided sufficient power
      for the Maintenance Study primary efficacy analysis. These participants did not contribute to
      the efficacy analyses performed for the Induction Study. Participants in both cohorts were
      assessed for treatment response at Week 6.

      In the Maintenance Phase vedolizumab-treated participants from both Cohort 1 and Cohort 2 who
      demonstrated a clinical response were randomized in a 1:1:1 ratio to double-blind treatment
      with vedolizumab administered every 4 weeks (Q4W), vedolizumab administered every 8 weeks
      (Q8W), or placebo. Vedolizumab-treated participants who did not demonstrate response at Week
      6 continued treatment with open-label vedolizumab, administered Q4W. Participants treated
      with double-blind placebo in the Induction Phase continued on double-blind placebo during the
      Maintenance Phase, regardless of treatment response during induction. The Maintenance Phase
      began at Week 6 and concluded with Week 52 assessments.

      After the Week 52 assessments, participants meeting protocol-defined criteria were eligible
      to enroll in Study C13008 (NCT00790933; Long-term Safety) to receive open-label vedolizumab
      treatment. Participants who withdrew early (prior to Week 52) due to sustained nonresponse,
      disease worsening, or the need for rescue medications may also have been eligible for Study
      C13008. Participants who did not enroll into Study C13008 were to complete a final on-study
      safety assessment at Week 66 (or final safety visit 16 weeks after the last dose) in the
      Maintenance Phase of Study C13006.
    

Intervention name(s): vedolizumab; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Vedolizumab for intravenous infusion; Placebo intravenous infusion
Other intervention name(s): Entyvio; MLN0002; MLN02; LDP-02
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment