Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories

Inclusion Criteria:

• Male or non pregnant, non lactating females aged 18 years and older.

• Subjects with a confirmed diagnosis of active UC of the rectum, extending no morethan 15 centimeters (cm) (5.9 inches) proximal to the anal verge as assessed bycolonoscopy performed at Visit 2. Note: Subjects may have a history of moreextensive UC (e.g., pancolitis), but have active disease only in the rectum at thetime of enrollment.

• Modified Mayo sub score for stool frequency of 1 3.

• Modified Mayo sub score for rectal bleeding of 0 2.

• Modified Mayo endoscopic sub score of 2 3.

• Total Modified Mayo Score (without physician global assessment) of 4-8.

Exclusion Criteria:

• History or current diagnosis of bacterial or other infectious colitis, radiationenteritis and radiation proctitis, Crohn's disease, collagenous colitis andindeterminate colitis.

• Prior gastrointestinal surgery except appendectomy, cholecystectomy, and hernia.

• Concomitant active lower gastrointestinal disease (except Irritable Bowel Syndrome)or distortion of intestinal anatomy.

• Bleeding hemorrhoids at the time of enrollment.

• Acute diverticulitis at the time of enrollment.

• Acute or chronic pancreatitis at the time of enrollment.

• Unmanaged celiac disease at the time of enrollment.

• Positive stool test for enteric pathogens, Clostridium difficile, or presence of ovaand parasites.

• Taking a prohibited medication.