The purpose of this study is to determine whether combining approved treatments (dual therapy) for Crohn’s disease is safe and improves patient outcomes. The treatment combinations referred to as “dual targeted therapy” are vedolizumab given by intravenous (IV) infusion plus adalimumab given by subcutaneous (SC- under the skin) injection, or vedolizumab given by IV infusion plus ustekinumab given by IV infusion for the first dose and SC injection for the rest of the doses. Treatment will consist of a 26-week dual therapy period and then, for some participants, a 26 week vedolizumab monotherapy (single therapy) treatment period. Study visits will consist of physical exams, laboratory tests, endoscopies, and completion of questionnaires. The combined use of vedolizumab, with either adalimumab or ustekinumab, as dual targeted therapy for the treatment of Crohn's disease is investigational.
What is the full name of this clinical trial?
An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Dual Targeted Therapy with Vedolizumab Intravenous and Adalimumab Subcutaneous or Vedolizumab IV and Ustekinumab IV/SC in Moderate to Severe Crohn's Disease