Clinical Trials

Inclusion Criteria:

• Diagnosis of ileal, ileo-colonic, or colonic Crohn's Disease (CD) for > 3 months prior to screening - Men or women age 18 - 80 years at the time of screening - Moderate to severely active CD, as defined by Crohn's Disease Activity Index (CDAI) AND endoscopic demonstration of inflammation - Stable dose of medications for Crohn's disease therapy -Prior treatment failure or intolerance with at least one Anti Tumor Necrosis Factor-Alpha Therapy (anti-TNF α) agent. -Effective contraception from screening, and for 36 weeks after the last dose of investigational product -No known history of active tuberculosis (TB) & negative assessment for TB/latent TB

Exclusion Criteria:

• Severe underlying immunosuppression
• Severe gastrointestinal complications; e.g., short bowel syndromes, obstructing strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation
• Significant infections at screening; Infected abscess, positive for Clostridium difficile, recent infectious hospitalization,
• Recent treatment with approved or investigational biologic therapy for Crohn's disease
• Recent or planned live attenuated vaccine
• History of cancer, except for basal cell carcinoma or CIS of the cervix with apparent cure ≥ 12 months before screening
• Pregnancy/breast feeding
• Drug abuse