Conditions: Psoriasis
Keywords: Moderate to Severe Plaque-Type Psoriasis Psoriasis Plaque-type psoriasis CNTO 1959 adalimumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 293
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: CNTO 1959 5 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40 arm 2: CNTO 1959 15 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40 arm 3: CNTO 1959 50 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40 arm 4: CNTO 1959 100 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40 arm 5: CNTO 1959 200 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40 arm 6: Adalimumab 80 mg at week 0 followed by 40 mg at week 1 and every second week through Week 39 (i.e., Weeks 3, 5, 7, etc.) arm 7: Placebo at weeks 0, 4, and 8; then crossover to CNTO 1959 100 mg at Week 16, then every 8 weeks through Week 40

Interventions: intervention 1: CNTO 1959 (5 mg) intervention 2: CNTO 1959 (15 mg) intervention 3: CNTO 1959 (50 mg) intervention 4: CNTO 1959 (100 mg) intervention 5: CNTO 1959 (200 mg) intervention 6: Adalimumab intervention 7: Placebo
Intervention descriptions: intervention 1: Subcutaneous (SC) injections intervention 2: SC injections intervention 3: SC injections intervention 4: SC injections intervention 5: SC injections intervention 6: SC injections intervention 7: SC injections

Protocol document: