A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects with Moderately to Severely Active Crohn’s Disease

Crohn's disease

Achievement of CDAI clinical remission (defined as CDAI < 150) at Week 12, Achievement of endoscopic response (defined as decrease in SES-CD > 50% from baseline or for subjects with isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline, as scored by blinded central reviewer) at Week 12

Achievement of SF/APS Clinical remission (defined as average daily SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline) at Week 12, Achievement of endoscopic remission (defined as SES-CD ≤ 4 and at least a 2-point reduction versus Baseline and no subscore greater than 1 in any individual variable, as scored by a blinded central reviewer) at Week 12, Achievement of ulcer-free endoscopy (defined as SES-CD ulcerated surface subscore of 0 in subjects with SESCD ulcerated surface subscore ≥ 1 at Baseline, as scored by a blinded central reviewer) at Week 12, Change from Baseline in FACIT-Fatigue at Week 12, Achievement of CR-100 CDAI clinical response (defined as at least a 100-point reduction from Baseline in CDAI) at Week 4

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