GA39925: A Study to Evaluate UTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis (H-43221)
GA39925: A Phase II, Randomized, Parallel-group, Double-blind, Double-dummy, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis. (GA39925)
The purpose of this study is to compare the effects of UTTR1147A versus Placebo (an inactive substance) and versus vedolizumab (ENTYVIO®) on you and your ulcerative colitis.
Inclusion / exclusion criteria. You may qualify for this study if:
- You are a male or female between the ages of 18 and 80;
- You have an established diagnosis of moderate to severe ulcerative colitis (UC) at least 3 months prior to enrollment;
- You are experiencing symptoms of abdominal pain and/or diarrhea; must be bleeding.
- You are unable to tolerate or have had insufficient response to prior immunosuppressant treatment (i.e., AZA, 6-MP, MTX, or TNF inhibitors [maximum of two prior TNF inhibitors, infliximab, adalimumab, golimumab and/or corticosteroid treatment.