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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
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03398148
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Inclusion Criteria:
Entry and completion of Study M16-067
Achieved clinical response after M16-067 treatment
If female must continue practicing birth control
Subject must be able and willing to give written informed consent
Exclusion Criteria:
Subject has high grade colonic dysplasia or colon cancer
Subject who has a known hypersensitivity to risankizumab
Confirmed positive urine pregnancy test
Subject with any active or chronic recurring infections
Have a known history of lymphoproliferative disease
Digestive Systems & Liver Disease
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Location
Hershey, PA