Efficacy and Safety of Budesonide Foam for Patients With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study to
assess the efficacy and safety of budesonide foam in subjects with active mild to moderate
proctitis or proctosigmoiditis. Approximately 430 subjects will be enrolled into the study
and receive either placebo foam or budesonide foam twice a day for 2 weeks followed by once
a day for 4 weeks. Participation in the study will last approximately 11 weeks, depending
on the timing of study visits.

During the study, eligible subjects will be allowed to maintain previously established oral
5-ASA treatment at doses up to 4.8g/day. Periodic safety monitoring, including physical
examinations, vitals, laboratory testing, and recording of AEs and concomitant medications,
will be performed during the study

Inclusion Criteria:

- Voluntarily sign written informed consent.

- Male or non-pregnant and non-lactating females ≥18 years of age.

- Confirmed diagnosis (by endoscopy procedure) of active, mild to moderate ulcerative
proctitis or proctosigmoiditis extending no further than 40cm from the anal verge.

- Must possess a baseline MMDAI score between 5 and 10.

- Visible blood in stool.

Exclusion Criteria:

- History or current diagnosis of Crohn's disease and indeterminate colitis.

- Prior gastrointestinal surgery except appendectomy and hernia.

- Concomitant active gastrointestinal disease or distortion of intestinal anatomy.

- History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic
or known gallbladder disease.

- Uncontrolled, previously diagnosed type 1 or 2 diabetes mellitus.

- Uncontrolled abnormal thyroid function.

- Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease.

- Hemoglobin levels < 7.5 g/dL.

- History of sclerosing cholangitis, cirrhosis, or hepatic impairment.

- Renal disease manifested by > 2.0mg/dL serum creatinine.

- History of avascular hip necrosis, active tuberculosis, ocular herpes simplex or
ocular varicella zoster, malignant disease, and HIV or hepatitis B or C.

- Adrenal insufficiency.

- Active systemic or cutaneous infection or toxic megacolon, fistula, perforation or
abscess.

- History of uncontrolled psychiatric disorders or seizure disorders.

- History of asthma requiring ongoing use of inhaled steroids.

- Recent history of drug or alcohol abuse.

- Positive stool test for bacterial pathogens, C diff or O&P.

- Vaccination within 28 days prior to Randomization.

- Allergies to budesonide or to any other items used in its preparation.

- Participation in another clinical trial in the past 30 days.

- Pregnant or at risk of pregnancy.

- Taking a prohibited medication. Some medications to treat UP/UPS are prohibited
during participation in the study, including laxatives and anti-diarrhea medications;
however, oral 5-ASA agents at doses up to 4.8g/day and daily fiber supplements are
allowed. Other medications (e.g., antibiotics, anti-seizure and anti-coagulant
medicines) are also prohibited.