Study of COLAL-PRED to Treat Moderate to Severe Ulcerative Colitis

Inclusion Criteria: * Females must be of non-childbearing potential evidenced by being surgically sterile, postmenopausal for at least 12 months or be using acceptable contraception methods such as contraceptive pill, or two forms of barrier contraception. * Disease Activity Index (DAI) Score of 6-10 (inclusive) at the Baseline Visit. * Previous colonoscopic and biopsy diagnosis of ulcerative colitis with negative evaluation of the ileum within 3 years of the screening visit. * Endoscopic evidence of moderate or severe mucosal disease as assessed by flexible sigmoidoscopy, with a minimum confirmed diagnosis of moderate ulcerative colitis. * The following concomitant prescription medications for ulcerative colitis are permitted if the following conditions are met: 1. Oral 5-aminosalicylic acid (5-ASA )therapy if the following 2 criteria are met: 1. Must be on a stable dose 2 weeks prior to baseline 2. Must maintain the stable dose until treatment end. 2. Azathioprine or 6-mercaptopurine or methotrexate if the 4 following criteria are met: 1. On therapy continually for at least 3 months prior to baseline. 2. And on a stable dose for at least 2 weeks prior to baseline. 3. And must maintain the stable dose until the end of study drug treatment. Exclusion Criteria: * History of colonic or rectal surgery, excluding hemorrhoidal surgery or an appendectomy. * Pregnant or breast-feeding females. * Diagnosis of diabetes, heart failure, unstable angina, hepatic cirrhosis, kidney failure, adrenocortical insufficiency, or any other unstable medical condition. * Known hypersensitivity to corticosteroids * Use of oral 5-aminosalicylic acid (5-ASA) or oral corticosteroids during the immediate screening period. * Use of immunosuppressive drugs or antibiotics at any time within four weeks prior to screening. * Diagnosis of Crohn's disease; indeterminate colitis; microscopic colitis; ischemic, infectious (e.g., salmonella, shigella, etc.), or amebic colitis; or gonococcal proctitis; Clostridium difficile colitis. * History of tuberculosis or HIV * Clinically significant abnormal laboratory test results, unless regarded by the Investigator as related to ulcerative colitis * History of alcohol or drug abuse * Known malignancy or history of malignancy that would reduce life expectancy * Recent immunization with live viral vaccines * History of or active peptic ulcer disease or gastritis * Generalized infections such as systemic fungal or hepatitis B or C * History of steroid induced severe hypertension, steroid-induced psychosis, or any other severe steroid-related adverse reaction