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 Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991

Brief description of study

The study consists of 3 sub-studies: This study is looking to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991. This study will also look to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in subjects who responded to induction treatment in Study M16-006 or Study M15-991 and to evaluate long-term safety of risankizumab in subjects who completed Sub-study 1 or 2.


Clinical Study Identifier: s17-00779
ClinicalTrials.gov Identifier: NCT03105102
Principal Investigator: David P Hudesman.
Other Investigator: Shannon Chang.


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