A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy (good or bad effects) and safety of ustekinumab in the treatment of patients with moderate to severe psoriasis in China.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centocor, Inc.
• Treatments: Ustekinumab

Criteria

Inclusion Criteria:

• Must be of Chinese ancestry

• Have had a diagnosis of plaque-type psoriasis at least 6 months prior to study start

• Have plaque-type psoriasis covering at least 10% of total BSA at screening and at the time of study start

• Have a Psoriasis Area and Severity Index (PASI) score of 12 or greater at study start

• Must be candidates for phototherapy or systemic treatment of psoriasis (either naive or history of previous treatment)

Exclusion Criteria:

• Currently have nonplaque forms of psoriasis

• Have current drug-induced psoriasis

• Have used any investigational drug within the previous 4 weeks

• Have used any biologic within the previous 3 months

• Be known to be infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis