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

Crohn's Disease

SS1: Proportion of subjects with clinical remission at Week 52, SS1: Proportion of subjects with endoscopic response at Week 52, SS3: Evaluation of Long-term safety

Proportion of participants with clinical remission per Crohn's Disease Activity Index (CDAI) at Week 52, Proportion of subjects with clinical remission at Week 52 among the subjects with clinical remission in Week 0, Proportion of subjects with ulcer-free endoscopy at Week 52, Proportion of subjects with endoscopic remission at Week 52, Mean change of IBDQ total score at Week 52 from baseline of induction, Mean change of FACIT fatigue at Week 52 from baseline of induction, Proportion of subjects who discontinued corticosteroid use for 90 days and achieved clinical remission at Week 52 in subjects taking steroids at baseline (of induction)., Proportion of subjects with CDAI clinical response at Week 52, Proportion of subjects with clinical remission and endoscopic response at Week 52, Proportion of subjects with enhanced clinical response at Week 52, Proportion of subjects with deep remission at Week 52, Exposure adjusted occurrence of CD-related hospitalizations from Week 0 through Week 52, Change from baseline of the induction study in Short Form-36 (SF- 36) Physical Component Summary score at Week 52

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Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden