Conditions: Psoriasis
Keywords: Psoriasis CNTO 1959 Guselkumab Placebo
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 192
Healthy volunteers: no

Brief summary:
The purpose of this study is to demonstrate the superiority of CNTO 1959 (guselkumab) to placebo in the treatment of participants with moderate to severe plaque-type psoriasis (A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches).

Detailed description:
A Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know about the study treatment), placebo-controlled (a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect) study of CNTO 1959 (Guselkumab) in the treatment of participants with moderate to severe plaque-type psoriasis. Participants will receive either treatment of CNTO 1959 (guselkumab) 50 milligram (mg) or 100 mg or Placebo 50 mg or 100 mg. Participants will primarily be assessed for Investigator's Global Assessment (IGA) Score and Psoriasis Area and Severity Index (PASI). Participants' safety will be monitored throughout the study.

Arms:
arm 1: Participants will receive subcutaneous injection of CNTO 1959 50 milligram (mg) and placebo 100 mg at Week 0, 4 and then every 8 weeks thereafter. arm 2: Participants will receive subcutaneous injection of CNTO 1959 100 milligram (mg) and placebo 50 mg at Week 0, 4 and then every 8 weeks thereafter. arm 3: Participants will receive subcutaneous injection of placebo 50 mg and 100 mg at Weeks 0, 4 and 12. At Week 16, participants will be randomized in sub-group 3a to receive either CNTO1959 50 mg and placebo 100 mg at Week 16, 20 and then every 8 weeks thereafter or sub-group 3b to receive CNTO 1959 100 mg and placebo 50 mg at Week 16, 20 and then every 8 weeks thereafter.

Interventions: intervention 1: CNTO 1959 50 mg intervention 2: CTNO 1959 100 mg intervention 3: Placebo 50 mg intervention 4: Placebo 100 mg
Intervention descriptions: intervention 1: Participants will receive subcutaneous injection of CNTO 1959 50 mg. intervention 2: Participants will receive subcutaneous injection of CNTO 1959 100 mg. intervention 3: Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 50 mg. intervention 4: Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 100 mg.

Protocol document: