A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.

• Drug: CP- 690 550
  
  Administration via oral route twice daily for the duration of treatment
• Other: placebo
  
  Administration via oral route twice daily for the duration of treatment

• Experimental: 15 mg BID
  
  Intervention: Drug: CP- 690 550
• Experimental: 10 mg BID
  
  Intervention: Drug: CP- 690 550
• Experimental: 3 mg BID
  
  Intervention: Drug: CP- 690 550
• Experimental: 0.5 mg BID
  
  Intervention: Drug: CP- 690 550
• Placebo Comparator: Placebo
  
  Intervention: Other: placebo

• Sandborn WJ, Panés J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.
• Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2019 May 8. pii: S1542-3565(19)30491-4. doi: 10.1016/j.cgh.2019.04.059. [Epub ahead of print]
• Sandborn WJ, Panés J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.
• Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.
• Sandborn WJ, Panés J, Zhang H, Yu D, Niezychowski W, Su C. Correlation Between Concentrations of Fecal Calprotectin and Outcomes of Patients With Ulcerative Colitis in a Phase 2 Trial. Gastroenterology. 2016 Jan;150(1):96-102. doi: 10.1053/j.gastro.2015.09.001. Epub 2015 Sep 12.
• Panés J, Su C, Bushmakin AG, Cappelleri JC, Mamolo C, Healey P. Randomized trial of tofacitinib in active ulcerative colitis: analysis of efficacy based on patient-reported outcomes. BMC Gastroenterol. 2015 Feb 5;15:14. doi: 10.1186/s12876-015-0239-9.
• Sandborn WJ, Ghosh S, Panes J, Vranic I, Su C, Rousell S, Niezychowski W; Study A3921063 Investigators. Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis. N Engl J Med. 2012 Aug 16;367(7):616-24. doi: 10.1056/NEJMoa1112168.

Inclusion Criteria:

• Patients must be at least 18 years of age at screening
• Males and female patients with clinical diagnosis of ulcerative colitis ?3 months prior to entry into the study.
• Male and female patients with active currently moderate to severe ulcerative colitis defined by Mayo score of ?6
• Patients with endoscopic sub-score of ?2 on the Mayo score determined within 7 days of baseline.

Exclusion Criteria:

• Diagnosis of Crohn's disease or diagnosis of indeterminate colitis
• Treatment naive subjects who have not had previous exposure to treatment for ulcerative colitis
• Patients that are currently receiving immunosuppressants, anti-TNF? therapy or interferon