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, including for female partners of male study subjects
• 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