Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative Colitis

Inclusion Criteria:

1. Male or female Chinese patients aged ≥18 to ≤ 70 years

2. Newly diagnosed or recurrent active ulcerative colitis (A gold standard for thediagnosis of ulcerative colitis is not available. The diagnosis should be establishedby a combination of medical history, clinical evaluation, and typical endoscopic andhistological findings. An infective cause should be excluded. Where there is doubtabout the diagnosis, endoscopic and histological confirmation is necessary after aninterval.)

3. Extent of colonic involvement and endoscopy subscore of Mayo score as confirmed bycolonoscopy (it should be done within 15 days prior to randomization)

4. Total Mayo score of at least 4 and a score of ≥ 2 for colonoscopy

5. Oralthe stability dose of 5-ASA medicine 14days.

6. Negative stool test at screening to rule out parasites and bacterial pathogens

7. The patient is compliant with Patient Daily Diary

8. Women with childbearing potential must have an efficacious contraception as judged bythe investigators and must have a negative pregnancy test result at screening

9. Signed Informed Consent obtained before any trial-related procedures.

Exclusion Criteria:

1. Severe/fulminant ulcerative colitis or toxic dilatation of the colon

2. Prior bowel resection surgery

3. Known infection of human immunodeficiency virus (HIV), Hepatitis B virus (HBV) orHepatitis C virus (HCV) (Note active Hepatitis B patients should be excluded from thestudy e.g. HBeAg positive or HBV DNA positive, with the exception for inactive HBsAgcarrier)

4. Take the following treatment:

5. Any 5-ASA enema or suppository therapy during the 14 days prior to screening

6. Corticosteroids (oral, intravenous, intramuscular, or rectal ) within 7 daysprior to screening

7. Any immunomodulating/suppressive agents during the 60 days prior to screening

8. Any Anti-TNF therapy during the 6 months prior to screening

9. Antibiotics (metronidazole and ciprofloxacin) within 7 days prior to screening

10. Loperamide, nicotine patch and mucilages within 7 days prior to screening

11. Traditional Chinese Medicine for the treatment of UC (any pharmaceutical form)within 7 days prior to screening

12. Patients allergic to 5-ASA and derivative, any of the excipients, aspirin, orsalicylates

13. Known significant hepatic function abnormalities, defined as the values of serum ALTor AST are equal to or more than twice of the upper limit of normal value

14. Women who are planning or actual pregnancy or lactation during study period

15. Alcohol addiction (>40 g of alcohol/day equivalent to >1 L of beer/day, 0.5 L ofwine/day, or 6 glasses (2 centiliter, cl) of liquor/day)

16. Drug addiction confirmed by patients' medical history

17. History of disease that would interfere with their participation in the trial,including malignant diseases, bleeding disorders, active gastric or active duodenalulcers, autoimmune diseases, and mental or emotional disorder

18. Patient participating or having participated in another clinical study 30 days priorto screening

19. Patient who are unlikely to comply with the protocol as judged by the investigator

20. Patients who are unable to fill in the Patient Daily Diary or follow data-capturingprocedures

21. Patients with one or more of the diseases: bacillary dysentery, amebic dysentery,chronic schistosomiasis, intestinal tuberculosis and Crohn's disease

22. Patients with any other disease or condition which might interfere with studyassessment as judged by the investigator.