Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

Inclusion Criteria:

1. Age 18 to 75 years, inclusive.

2. Established diagnosis of UC, based on clinical history, exclusion of infectiouscauses, and characteristic endoscopic and histologic findings.

3. Active mild or moderate UC with an ulcerative colitis disease activity index (UCDAI)score ≥4 and ≤10, with a mucosal appearance score of ≥1, and physician's rating ofdisease activity of 1 or 2.

4. Experiencing active UC (flare) despite a therapeutic dose of an oral 5-ASA (forexample, mesalamine ≥2.4 g/day for ≥6 weeks prior to randomization, or equivalent). Atscreening, photographic evidence of active UC based on mucosal appearance must beobtained.

5. Women of childbearing potential or men of reproductive potential must be willing touse an acceptable form of contraception.

6. Able to comprehend the full nature and purpose of the study, including possible risksand side effects, and also able to comply with all requirements of the study. Must beable to understand and voluntarily sign an informed consent prior to any studyprocedures.

Exclusion Criteria:

1. Limited distal proctitis (from anal verge to 15 centimeters [cm] above the pectinealline).

2. Severe UC (UCDAI >10 or physician global assessment [PGA] >2), or non-active UC (UCDAI <4).

3. Infectious colitis or any recent history of infectious colitis (within 30 days ofScreening).

4. Active malignancy or carcinoma in situ within the last 5 years (treated non-melanomaskin cancers are not exclusionary).

5. Active ulcer or bleeding disorder that may affect evaluation of blood in the stool.

6. Evidence or history of toxic megacolon or bowel resection.

7. Crohn's disease or indeterminate colitis.

8. Known hypersensitivity to budesonide or any ingredients of the budesonide MMX tablets.

9. Active tuberculosis or other active systemic or local bacterial, fungal, or viralinfection.

10. Liver cirrhosis, evident hepatic or renal disease or insufficiency, or significantimpairment of the biohumoral parameters (≥2.5upper limit of normal [ULN] for alanineaminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, or ≥2ULNfor creatinine). Elevations in bilirubin due to benign conditions such as Gilbert'ssyndrome are not exclusionary.

11. Severe diseases in other organs or systems.

12. Local or systemic complications or other pathological states requiring therapy withcorticosteroids and/or immunosuppressive agents.

13. Type 1 diabetes.

14. Glaucoma or with a family history of glaucoma in first-degree relatives.

15. Known hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), according tothe local privacy policy.

16. Severe anemia (<9 g/deciliter [dL] hemoglobin), leukopenia (<2.510^9 white bloodcells [WBC]/liter [L]), or granulocytopenia (<1.210^9 cells/L).

17. Participants with a history of pancolitis (disease that extends to the hepatic flexureor beyond) for ≥8 years or left-sided colitis (disease confined to the left colon [that is, distal to the splenic flexure]) ≥15 years who have not yet completed asurveillance colonoscopy for dysplasia/colorectal cancer screening within the pastyear.

18. Prior budesonide MMX treatment.

19. Use of oral corticosteroids including other budesonide formulations within the last 4weeks prior to randomization.

20. Use of any rectal 5-ASA or corticosteroid formulations within the last 2 weeks priorto randomization.

21. Use of immunosuppressive agents within the last 8 weeks prior to randomization.

22. Use of anti-tumor necrosis factor-alpha (TNFα) agents or other biologic therapieswithin the last 3 months prior to randomization.

23. Participation in experimental therapeutic studies within 30 days of randomization (orwithin the last 3 months if in an anti-TNFα or biologic agent study). Note:participants who participated in observational-only studies (and who did not receivestudy therapy) are not excluded.

24. Any other medical condition that, in the Principal Investigator's opinion, would makethe administration of the study drug or study procedures hazardous to the participantor obscure the interpretation of adverse events (AEs) by the appropriate independentethics committee/institutional review board.