Key Inclusion Criteria:
Male or female aged 18 – 75 years old.
Confirmed
diagnosis of CD for at least 3 months prior to Baseline.
Simplified endoscopic score for CD (SES-CD) excluding the presence of narrowing component, ≥ 6 (or ≥ 4 for subjects with isolated ileal disease), confirmed by a central reader.
Average daily very soft/liquid stool frequency (SF) ≥ 4 and/or average daily abdominal pain (AP) score ≥ 2 at Baseline.
Demonstrated intolerance or inadequate response to one or more of the following categories of drugs :
M14-431: biologic therapy (adalimumab, certolizumab, infliximab, natalizumab, ustekinumab and/or vedolizumab)
M14-433: aminosalicylates, oral locally acting steroids, systemic steroids, immunomodulators (prior biologic use without failure or intolerance is allowed in up to 30% of subjects)
ABT-494 CD- SEV Training | 11May2017 | Copyright © 2016 AbbVie