A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis (X-PLORE)

• Psoriasis Area and Severity Index (PASI) 75% or greater improvement from baseline [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  Overall assessment of induration, scaling, and erythema and body surface area involved by the disease
• The difference in the PGA score of cleared (0) or minimal (1) response rate between CNTO 1959 treatment groups and adalimumab treatment group [ Time Frame: Weeks 16 and 40 ] [ Designated as safety issue: No ]
  Overall assessment of induration, scaling, and erythema
• The change from baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  Assessment of the impact of the disease on a subject's quality of life

The purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the treatment of patients with moderate to severe plaque psoriasis.

This is a multicenter, dose-ranging study of CNTO 1959 in patients with moderate to severe plaque psoriasis. Patients who satisfy all inclusion and exclusion criteria will be assigned by chance to one of 7 treatment groups: a placebo group (a placebo is a treatment identical in appearance to CNTO 1959 but does not contain active drug), 1 of 5 dose groups for CNTO 1959, or adalimumab. Patients assigned to adalimumab will be dosed according to the labeled dosing for psoriasis. At Week 16, patients initially assigned to placebo will begin receiving CNTO 1959. Patients initially assigned to CNTO 1959 will continue to receive the same assigned dose level of study agent from Week 16 through Week 40. Patients receiving adalimumab will continue the labeled dosing regimen. All patients will be reassessed for clinical response every 4 weeks from Week 4 through Week 40. Patients will continue dosing through Week 40, with a subsequent efficacy and safety follow-up visit at Week 52. Patient safety will be monitored throughout the study.

• Drug: CNTO 1959 (5 mg)
  CNTO 1959: type=exact number, unit=mg, number=5, form=solution for injection, route=subcutaneous use, at Wks 0, 4, and 16, then every 12 weeks through Wk 40.
• Drug: CNTO 1959 (15 mg)
  CNTO 1959: type=exact number, unit=mg, number=15, form=solution for injection, route=subcutaneous use, Wks 0, 8, and 16, then every 8 weeks through Wk 40.
• Drug: CNTO 1959 (50 mg)
  CNTO 1959: type=exact number, unit=mg, number=50, form=solution for injection, route=subcutaneous use, Wks 0, 4, and 16, then every 12 weeks through Wk 40.
• Drug: CNTO 1959 (100 mg)
  CNTO 1959: type=exact number, unit=mg, number=100, form=solution for injection, route=subcutaneous use, Wks 0, 8, and 16, then every 8 weeks through Wk 40.
• Drug: CNTO 1959 (200 mg)
  CNTO 1959: type=exact number, unit=mg, number=200, form=solution for injection, route=subcutaneous use, Wks 0, 4, and 16, then every 12 weeks through Wk 40.
• Drug: Adalimumab
  Adalimumab: type=exact, unit=mg, form=solution for injection, route=subcutaneous use, number=80, Wk 0; number=40, Wk 1 and every second week through Wk 39 (e.g., Wks 3, 5, 7, etc.)
• Drug: Placebo to CNTO 1959 (100 mg)
  Form=solution for injection, route=subcutaneous use, Wks 0, 4, and 8; then crossover to CNTO 1959, 100 mg, at Week 16, then every 8 weeks through Wk 40.

• Experimental: CNTO 1959 (5 mg)
  Intervention: Drug: CNTO 1959 (5 mg)
• Experimental: CNTO 1959 (15 mg)
  Intervention: Drug: CNTO 1959 (15 mg)
• Experimental: CNTO 1959 (50 mg)
  Intervention: Drug: CNTO 1959 (50 mg)
• Experimental: CNTO 1959 (100 mg)
  Intervention: Drug: CNTO 1959 (100 mg)
• Experimental: CNTO 1959 (200 mg)
  Intervention: Drug: CNTO 1959 (200 mg)
• Active Comparator: Adalimumab (approved psoriasis dosing)
  Intervention: Drug: Adalimumab
• Placebo Comparator: Placebo to CNTO 1959 (100 mg)
  Intervention: Drug: Placebo to CNTO 1959 (100 mg)

Inclusion Criteria:

• Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent
• Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)
• Must be considered, in the opinion of the investigator, suitable candidates for adalimumab therapy
• If a woman, she must be postmenopausal, or if premenopausal, she must be either surgically sterile, practicing a highly effective method of birth control, or not heterosexually active during the study and for 5 months after receiving the last dose of study drug
• If a man, he must agree to use a double-barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study and for 5 months after receiving the last dose of study drug.

Exclusion Criteria:

• History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
• Has a contra-indication to anti-TNF therapy
• Has a history of chronic or recurrent infectious disease
• Has a nonplaque form of psoriasis or has drug-induced psoriasis
• Has been previously treated with adalimumab
• Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23, (including but not limited to ustekinumab, briakinumab [ABT-874], AIN457, and SCH900222) within 6 months of the first administration of study agent.