This is a Phase 3, randomized, double-blind, placebo-controlled induction study to evaluate the efficacy and safety of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult subjects with moderately to severely active CD.
Subjects who consent and meet all of the inclusion criteria and none of the exclusion criteria will be enrolled into this study, which encompasses 2 parts: (Part 1) a randomized, double-blind, placebocontrolled induction; and (Part 2) an Extended Treatment Period for non-responders from Part 1.
Subjects will be randomized in a 2:1 ratio to upadacitinib 45 mg once daily (QD) or matching placebo for 12 weeks.
Visits during the study will occur at Baseline and Weeks 2, 4, 8, and 12/Premature Discontinuation to collect clinical, endoscopic and laboratory assessments of disease activity.
At Week 12, subjects achieving clinical response may be eligible to enter the 52-week, double-blind, maintenance portion of Study M14-430.
All subjects who do not achieve clinical response at Week 12 will be eligible to participate in Part 2 (Extended Treatment Period) to receive double-blind upadacitinib until Week 24/PD.