Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab
      SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to
      severely active ulcerative colitis (UC) who achieved clinical response following
      administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
    

Detailed description: 
      The drug being tested in this study is called vedolizumab subcutaneous (vedolizumab SC).
      Vedolizumab SC is being tested to treat people who have moderate to severely active
      ulcerative colitis. This study will look at clinical remission as well as mucosal healing,
      durable clinical response, durable clinical remission, and corticosteroid free remission in
      participants with UC who receive vedolizumab SC maintenance therapy after having achieved a
      clinical response to vedolizumab IV induction therapy.

      The study enrolled 383 patients. All participants will enter into a 6-week Induction Phase
      where they will be administered open-label vedolizumab IV 300 mg via intravenous infusion
      (IV) at Week 0 (Day 1) and Week 2 (Day 15), and will then be assessed for a clinical response
      at Week 6. Participants who achieve a clinical response at Week 6 will be randomly assigned
      to one of the three treatment groups:

      Vedolizumab SC 108 mg Q2W and Placebo IV Q8W Vedolizumab IV 300 mg Q8W and Placebo SC Q2W
      Placebo SC Q2W and Placebo IV Q8W

      Participants who do not achieve a clinical response at Week 6 will not be randomized in to
      the Maintenance Period, and will receive a third infusion of vedolizumab IV 300 mg at Week 6.

      This multi-center trial will be conducted worldwide. The overall time to participate in this
      study is up to 71 weeks (up to 4 weeks of screening, 52 weeks of treatment and 18 weeks of
      safety follow-up). Participants will make multiple visits to the clinic, plus a final visit
      18 weeks after last dose of study drug for a follow-up assessment. Participants will also
      participate in a long-term safety follow-up, by phone, at 6 months after the last dose of
      study drug.

      After the Week 52 assessments, participants meeting protocol-defined criteria were eligible
      to enroll in Study MLN0002SC-3030 (NCT02620046; 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 MLN0002SC-3030. Participants who did not enroll into Study MLN0002SC-3030
      were to complete a final on-study safety assessment at Week 68 (or final safety visit 18
      weeks after the last dose) in the Maintenance Phase of Study MLN0002SC-3027.
    

Intervention name(s): Vedolizumab 300 mg IV; Placebo IV; Vedolizumab 108 mg SC; Placebo SC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Vedolizumab intravenous infusion; Vedolizumab intravenous infusion placebo; Vedolizumab subcutaneous injection; Vedolizumab subcutaneous injection placebo
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy