An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis

Inclusion Criteria:

• Clinical UC diagnosis ≥ 6 months prior to screening with minimum disease extent of ≥ 15cm from anal verge.

• Active UC defined as a TMS of 4-11 (inclusive) with endoscopic subscore of ≥ 2 andrectal bleeding subscore of ≥ 1 at screening.

• Females of childbearing potential must have a negative pregnancy test at screening andbaseline visits and must agree to use acceptable methods of birth control while in thetrial and for 30 days after taking the last dose of study drug.

• May be currently receiving treatment with oral aminosalicylates (ASA) for ≥ 6 weeks ata stable dose for ≥ 3 weeks prior to the screening screening endoscopy and/orthiopurine at a stable dose ≥ 8 weeks prior to the screening endoscopy and/orprednisone (dose 20 mg daily) or equivalent for ≥ 4 weeks and receiving stable dosefor ≥ 2 weeks prior to screening endoscopy

• able to provide written informed consent and be compliant with study procedures.

Exclusion Criteria:

• History of Crohn's disease (CD) or indeterminate colitis or the presence or history offistula consistent with CD.

• Presence of colon polyps.

• Severe extensive disease that in the investigators discretion is likely to requirecolonic surgery during the 8 week double-blind portion of the trial (eg, fulminantcolitis, toxic megacolon, bowel perforation, evidence of acute abdomen).

• History of alcohol or drug abuse within 1 year of randomization.

• History of cancer including solid tumors and hematological malignancies (except basalcell and in situ squamous cell carcinomas of the skin that have been adequatelytreated with no recurrence for ≥ 1 year prior to screening.

• History or currently active primary or secondary immunodeficiency.

• Clinically relevant hepatic, neurologic, pulmonary, ophthalmological,gastrointestinal, endocrine, psychiatric, or other major systemic disease makingimplementation of the study difficult or that would put the subject at risk byparticipating in the study

• Positive test for Clostridium difficile or positive stool culture for entericpathogens or presence of ova or parasites at screening.

• Liver function tests > 1.5 x upper limit of normal (ULN) or direct bilirubin > 1.5 xULN

• Hemoglobin < 8.5 g/dl

• Neutrophils < 1500/mm3

• White blood cell (WBC) count < 3000/mm3

• Platelets < 80000 mm3

• International normalized ratio (INR) > 1.5

• Treatment with an immunosuppressant agent within 8 weeks of screening.

• Previous exposure to ≥ 2 approved or investigational biologic agents to treat UC.

• History of UC treatment with a biologic agent within 12 weeks of screening.

• Treatment with rectal steroids within 2 weeks of screening.

• Treatment with an investigational agent within 30 days of screening.