A Phase 3 Trial to Look at the Safety and Effectiveness of Ustekinumab in Korean and Taiwanese Subjects With Moderate to Severe Plaque-type Psoriasis

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of Ustekinumab in the treatment of patients with moderate to severe psoriasis in South Korea and Taiwan.

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

Details

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

Criteria

Inclusion Criteria:

• Must be of Taiwanese or Korean ancestry living in Taiwan or South Korea, respectively

• Have a diagnosis of plaque-type psoriasis at least 6 months prior to first administration of study agent (patients with concurrent psoriatic arthritis may be enrolled)

• Have plaque-type psoriasis covering at least 10% of total body surface area at screening and at the time of first study agent administration

• PASI score of 12 or greater at the time of screening and at time of first study agent administration

• Candidate of phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment)

• Be able to adhere to the study visit schedule and other protocol requirements

• Capable of giving informed consent prior to any study related procedures.

Exclusion Criteria:

• Currently have a non-plaque form of psoriasis

• Have current drug-induced psoriasis

• Are pregnant or nursing or planning pregnancy (both men and women) while enrolled in the study

• Have used any investigational drug within the previous 4 weeks or 5 times the half life of the investigational agent, whichever is longer

• Have used any biologic within the previous 3 months or 5 times the half life of the biologic, whichever is longer

• Have been hospitalized in the past 3 years for asthma, ever required intubation for treatment of asthma, currently require oral corticosteroids for the treatment of asthma, or required more than one short-term course of oral corticosteroids for asthma within the previous year

• Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis prior to screening.