Summary:
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Inclusion Criteria:
- Sex - Male or Female
- Age - 18 to 80 years of age
- Diagnosis of CD for at least 3 months prior to baseline
- Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
- Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
Exclusion Criteria:
- Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or short bowel syndrome
- Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
- Have a stoma, ileoanal pouch or ostomy
- Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline
- Have a diagnosis of Hepatitis B, Hepatitis C, HIV