A Placebo-Controlled Double-Blind Comparative Study of CNTO1275 in Patients With Plaque Type Psoriasis

NCT00723528 Phase 3 COMPLETED Results posted

The purpose of this study is to evaluate the safety and efficacy of ustekinumab (CNTO 1275) compared with placebo in participants with moderate to severe plaque type psoriasis.

Details

Lead sponsor	Janssen Pharmaceutical K.K.
Phase	Phase 3
Status	COMPLETED
Enrolment	158
Start date	2008-03
Completion	2010-03

Conditions

• Psoriasis

Interventions

• Placebo (CP)
• Ustekinumab 45 mg (CP)
• Ustekinumab 90 mg (CP)
• Placebo A (After CP)
• Placebo B (After CP)
• Ustekinumab 45 mg (After CP)
• Ustekinumab 90 mg (After CP)

Primary outcomes

• Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score — Week 12
  Percentage of participants with \>=75% improvement in PASI score at Week 12 from Baseline was reported. PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Baseline visit refers to Week 0.

Countries

Japan