Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis

Exclusion Criteria

• •The presence of any of the following will exclude a subject from enrollment:
• •Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis.
• •Ulcerative colitis restricted to the distal 15 cm or less (eg, ulcerative proctitis).
• •Subjects who have had surgery as a treatment for UC or who, in the opinion of the Investigator, are likely to require surgery for UC during the study.
• •Clinical signs suggestive of fulminant colitis or toxic megacolon.
• •Prior use of any tumor necrosing factor (TNF) inhibitor (or any biologic agent).
• •Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine or thalidomide.
• •Use of intravenous (IV) corticosteroids within 2 weeks of the Screening Visit.
• •Use of immunosuppressants (AZA, 6-MP or MTX) within 8 weeks of the Screening Visit.
• •Use of topical treatment with 5-ASA or corticosteroid enemas or suppositories within 2 weeks of the Screening Visit.
• •History of any clinically significant neurological, renal, hepatic, gastrointestinal, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the investigator's opinion, would preclude participation in the study.