A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled (Entyvio), Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of A Study Drug in Participants with Moderately to Severely Active UC...

Study Description

• Patients will be randomly assigned to 1 of 5 study groups:  three groups of active investigational study intervention at differing doses, one group of the active comparator Entyvio (Vedolizumab), and one group of placebo.  
• The study duration will consist of a 4-week screening period, a 54-week treatment period and an 18-week safety follow-up period.  
• The total study period will last up to 72 weeks.  
• The study doctor and study staff will not know if a participant is receiving study drug, Entyvio (vedolizumab) or placebo.  
• Patients will have an 80% chance of getting an active drug.  

Description of Treatment or Intervention (Mechanism of Action)

• The investigational study intervention is believed to reduce inflammation in the colon and could possibly decrease the signs and symptoms of ulcerative colitis. 
• The investigational study intervention will be given to patients who have failed prior treatment, have had good response or have never had treatment with a biologic to see how well the drug works in different UC populations as compared to the active comparator.

Patient Participation Requirements

• Patients will have a total of 19 study visits over the 72-week period.
• After screening, study intervention will be given through a needle in a vein (intravenously) for the first three visits. 
• At all other study visits, the study intervention will be given both intravenously and as an injection under your skin (subcutaneous) every four weeks. 
• Patients will also be asked to complete an electronic diary to record their general health information and UC symptoms from screening until you exit the study.  
• Diaries will be completed at specific intervals from screening until you exit the study.  
• At scheduled clinic visits, patients will also fill out questionnaires.  
• Colonoscopy will be performed at screening and two additional flexible sigmoidosopies will be performed thereafter.  
• Blood and stool samples will also be taken at screening and at specific times during the study.

Possible Risks & Side Effects

The study doctor will review all the possible risks and side effects of the experimental study intervention and active control at screening.