M16-067: A Study to Evaluate Risankizumab in Subjects with Ulcerative Colitis Who Have Failed Prior Biologic Therapy (Inspire) (H-43035)
M16-067: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy (Inspire)
The purpose of this study is to evaluate the efficacy and safety of different doses of risankizumab and determine how well it works in subjects with moderate to severe ulcerative colitis. This study will also evaluate how the body metabolizes and eliminates the study drug.
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 unable to tolerate or have had insufficient response to treatment with medications that help reduce the inflammation associated with UC such as infliximab, adalimumab, vedolizumab, certolizumab , golimumab.