NCT02325219

An Efficacy and Safety of CNTO 1959 (Guselkumab) in Participants With Moderate to Severe Plaque-type Psoriasis

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	CNTO 1959 50 mg	Participants will receive subcutaneous injection of CNTO 1959 50 mg.
DRUG	CTNO 1959 100 mg	Participants will receive subcutaneous injection of CNTO 1959 100 mg.
DRUG	Placebo 50 mg	Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 50 mg.
DRUG	Placebo 100 mg	Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 100 mg.

Timeline

• Start date: 2014-12-19
• Primary completion: 2016-03-02
• Completion: 2019-02-08
• First posted: 2014-12-24
• Last updated: 2020-05-22
• Results posted: 2020-05-14

Locations

27 sites across 1 country: Japan