Effectiveness and Safety of 3 Dosing Regimens of CP-690,550 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

• Drug: CP-690,550
  
  tablets, 2 mg BID for 12 weeks
• Drug: CP-690,550
  
  tablets, 5 mg BID for 12 weeks
• Drug: CP-690,550
  
  tablets, 15 mg BID for 12 weeks
• Drug: Placebo
  
  tablets, BID for 12 weeks

• Experimental: 1
  
  Intervention: Drug: CP-690,550
• Experimental: 2
  
  Intervention: Drug: CP-690,550
• Experimental: 3
  
  Intervention: Drug: CP-690,550
• Placebo Comparator: 4
  
  Intervention: Drug: Placebo

• Valenzuela F, Papp KA, Pariser D, Tyring SK, Wolk R, Buonanno M, Wang J, Tan H, Valdez H. Effects of tofacitinib on lymphocyte sub-populations, CMV and EBV viral load in patients with plaque psoriasis. BMC Dermatol. 2015 May 8;15:8. doi: 10.1186/s12895-015-0025-y.
• Menter A, Papp KA, Tan H, Tyring S, Wolk R, Buonanno M. Efficacy of tofacitinib, an oral janus kinase inhibitor, on clinical signs of moderate-to-severe plaque psoriasis in different body regions. J Drugs Dermatol. 2014 Mar;13(3):252-6.
• Bushmakin AG, Mamolo C, Cappelleri JC, Stewart M. The relationship between pruritus and the clinical signs of psoriasis in patients receiving tofacitinib. J Dermatolog Treat. 2015 Feb;26(1):19-22. doi: 10.3109/09546634.2013.861891. Epub 2013 Dec 2.
• Strober B, Buonanno M, Clark JD, Kawabata T, Tan H, Wolk R, Valdez H, Langley RG, Harness J, Menter A, Papp K. Effect of tofacitinib, a Janus kinase inhibitor, on haematological parameters during 12 weeks of psoriasis treatment. Br J Dermatol. 2013 Nov;169(5):992-9. doi: 10.1111/bjd.12517.
• Papp KA, Menter A, Strober B, Langley RG, Buonanno M, Wolk R, Gupta P, Krishnaswami S, Tan H, Harness JA. Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a Phase 2b randomized placebo-controlled dose-ranging study. Br J Dermatol. 2012 Sep;167(3):668-77. doi: 10.1111/j.1365-2133.2012.11168.x.

Inclusion Criteria:

• Have been diagnosed with plaque psoriasis for at least 6 months.
• Have plaque psoriasis covering at least 15% of their total body.
• Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).
• Be willing and able to comply with scheduled visits, treatment plan and other study procedures.

Exclusion Criteria:

• Currently have non-plaque forms of psoriasis or drug-induced psoriasis.
• Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy.
• Subject is participating in another trial using an investigational agent or procedure.
• Women who are pregnant or breast-feeding or considering becoming pregnant.