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A Multicenter, Randomized, Double-Blind, Placebo-Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis
There are three sub-studies in this protocol. The first scope of the study is to continue the treatment for Ulcerative colitis with risankizumab versus placebo as maintenance therapy in subjects with moderate to severe UC who responded to IV risankizumab induction treatment (study M16-067).
The second scope evaluates the safety and efficacy of two different dosing regimens for risankizumab as maintenance therapy in subjects who responded to the induction treatment in study M16-067.
The third scope is to evaluate the long-term safety of risankizumab in subjects who completed sub-study 1 or 2 or subjects who responded to induction treatment in study M16-067 with no final endoscopy.
Z Stella Chroneos at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
All
18 year(s) or older
NCT03398148
Digestive Systems & Liver Disease